Trial Outcomes & Findings for Flura-seq for Evaluating the Effects of Different Hyperthermic Intraperitoneal Chemotherapy Regimens on the Transcriptome of Pseudomyxoma Peritonei (NCT NCT06839378)

Last Updated: 2026-01-06

Results Overview

Main index parameters: information on the amount of differentially expressed genes and the magnitude of change between the cisplatin group and the cisplatin+ docetaxel group. The amount of differentially expressed genes is expressed as mean ± standard deviation and statistically analyzed by t-test or rank-sum test, and the comparison between groups is performed by unpaired t-test. Differences are considered statistically significant when P\< 0.05. Based on the statistical results, the efficacy of the two HIPEC regimens (cisplatin or cisplatin+ docetaxel) on PMP will be analyzed. Expected results and clinical interpretation: More changes in newly generated RNA in the tumor tissue indicate a greater impact of HIPEC on the transcriptome of the tumor cells, possibly indicating better efficacy.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

From the initiation of Cytoreductive Surgery (CRS) to the completion of Hyperthermic Intraperitoneal Chemotherapy (HIPEC). CRS takes 4-8 hours, HIPEC takes 1 hour. Pre and post-HIPEC tumor tissues were collected for RNA-sequencing.

Results posted on

2026-01-06

Participant Flow

Recruitment was conducted at a single-center hospital (Beijing Tsinghua Changgung Hospital, Department of Peritoneal Oncology) from February 17, 2025, to August 6, 2025. Potential participants were identified through outpatient clinics and physician referrals. All screened individuals underwent preliminary eligibility assessment based on the study's inclusion and exclusion criteria.

After providing informed consent, 36 enrolled participants entered a screening phase to confirm eligibility based on predefined inclusion/exclusion criteria. All 36 participants successfully completed screening and proceeded to randomization. No participants were excluded or withdrew during this phase. Using a randomization table provided by the Beijing Tsinghua Changgung Hospital Clinical Data Management Center, the 36 participants were randomly assigned to two groups (18 participants per group

Participant milestones

Participant milestones
Measure	Experimental : Cisplatin Group 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor.	Active Comparator : Cisplatin + Docetaxel Group 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor.
Overall Study STARTED	18	18
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flura-seq for Evaluating the Effects of Different Hyperthermic Intraperitoneal Chemotherapy Regimens on the Transcriptome of Pseudomyxoma Peritonei

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental : Cisplatin Group n=18 Participants 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor.	Active Comparator : Cisplatin + Docetaxel Group n=18 Participants 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor.	Total n=36 Participants Total of all reporting groups
Age, Customized Age 18-75 years old	18 Participants n=9 Participants	18 Participants n=6 Participants	36 Participants n=9 Participants
Sex: Female, Male Female	9 Participants n=9 Participants	10 Participants n=6 Participants	19 Participants n=9 Participants
Sex: Female, Male Male	9 Participants n=9 Participants	8 Participants n=6 Participants	17 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	18 Participants n=9 Participants	18 Participants n=6 Participants	36 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) White	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=9 Participants	18 Participants n=6 Participants	36 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Histological characteristics of 36 PMP patients treated with CRS+HIPEC Acellular mucus	0 Participants n=9 Participants	1 Participants n=6 Participants	1 Participants n=9 Participants
Histological characteristics of 36 PMP patients treated with CRS+HIPEC low-grade mucinous carcinoma peritoneum	10 Participants n=9 Participants	12 Participants n=6 Participants	22 Participants n=9 Participants
Histological characteristics of 36 PMP patients treated with CRS+HIPEC high-grade mucinous carcinoma peritoneum	5 Participants n=9 Participants	5 Participants n=6 Participants	10 Participants n=9 Participants
Histological characteristics of 36 PMP patients treated with CRS+HIPEC high-grade mucinous carcinoma peritoneum with sign	3 Participants n=9 Participants	0 Participants n=6 Participants	3 Participants n=9 Participants

PRIMARY outcome

Timeframe: From the initiation of Cytoreductive Surgery (CRS) to the completion of Hyperthermic Intraperitoneal Chemotherapy (HIPEC). CRS takes 4-8 hours, HIPEC takes 1 hour. Pre and post-HIPEC tumor tissues were collected for RNA-sequencing.

Outcome measures

Outcome measures
Measure	Experimental : Cisplatin Group n=18 Participants 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor.	Active Comparator : Cisplatin + Docetaxel Group n=18 Participants 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor.
Changes in RNA in Tumor Tissues Before and After HIPEC	1413 Numbers of changed RNA Standard Deviation 876	1927 Numbers of changed RNA Standard Deviation 992

SECONDARY outcome

This secondary outcome quantifies and compares differentially expressed genes (DEGs) identified via Flura-seq (spatial transcriptomics) and bulk RNA-seq methodologies across all samples collected before and after hyperthermic intraperitoneal chemotherapy (HIPEC).

Outcome measures

Outcome measures
Measure	Experimental : Cisplatin Group n=36 Participants 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor.	Active Comparator : Cisplatin + Docetaxel Group n=36 Participants 5-FU (400 mg/m²) has been injected IV bolus before operation. After CRS, the patients have been treated with cisplatin or cisplatin + docetaxel HIPEC respectively. The tumor tissue samples of patients have been collected before and after HIPEC treatment. The tumor tissue samples before and after HIPEC treatment have been sequenced by Flura-seq using high-throughput sequencing technology, and the changes of newly generated transcripts in tumor tissue during HIPEC have been analyzed. The differentially expressed genes in the cisplatin group and the cisplatin + docetaxel group have been compared to evaluate the effect of different HIPEC regimens on the transient transcriptome of PMP tumor.
Comparison of Transcriptomic Changes Detected by Flura-seq vs. Bulk RNA-seq	1,690 Numbers of changed RNA Standard Deviation 940	340 Numbers of changed RNA Standard Deviation 300

Adverse Events

Cisplatin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cisplatin + Docetaxel Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Yan Li, Director of the Department of Peritoneal Oncology

Tsinghua Changgung Hospital

Phone: +86 18612709123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cisplatin Group n=18 participants at risk After completing CRS, the patient will undergo cisplatin HIPEC treatment. Add 120 mg of cisplatin to 3000 ml of physiological saline, heat to 43 ℃, perfuse at a flow rate of 400 ml/min, and perfuse for 60 minutes.	Cisplatin + Docetaxel Group n=18 participants at risk After completing CRS, the patient will undergo HIPEC treatment with cisplatin and docetaxel. Add 120 mg of docetaxel and 120 mg of cisplatin to 3000 ml of physiological saline, heat to 43 ℃, perfuse at a flow rate of 400 ml/min, and perfuse for 60 minutes.
General disorders Venous Thromboembolism Occurrence (time, symptoms and signs, ultrasound/CTA, measures, prognosis)	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
General disorders Symptomatic Deep - Vein Thrombosis	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Vascular disorders Pulmonary Embolism	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Gastrointestinal disorders Post - operative Gastrointestinal Fistula	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Blood and lymphatic system disorders Bone Marrow Suppression	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Renal and urinary disorders Urinary Fistula	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Renal and urinary disorders Renal Insufficiency	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Blood and lymphatic system disorders Massive Hemorrhage	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Respiratory, thoracic and mediastinal disorders Respiratory system (pneumonia, pleural effusion, pneumothorax)	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Cardiac disorders Circulatory system (arrhythmia, hypotension, ischemic cardiomyopathy, pulmonary edema)	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Nervous system disorders Nervous system (stroke, neurological paralysis)	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Infections and infestations Intra - abdominal Infection	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Skin and subcutaneous tissue disorders Incision dehiscence, infection	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.
Injury, poisoning and procedural complications Venous catheterization (septicemia, embolism, pneumothorax)	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.	0.00% 0/18 • From the end of CRS+HIPEC treatment to 30 days after surgery. The analysis population comprised all 36 enrolled patients who met the pre-specified inclusion and exclusion criteria. This clinical trial mainly collected Grade 3 - 4 serious adverse events. Other non-serious adverse events are not systematically collected or reported.