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Intraperitoneal Chemotherapy Guided by the Detection of DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer

NCT05497739 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-08-11

No results posted yet for this study

Summary

Peritoneal metastasis is a major pattern of gastric cancer recurrence and predicts poor prognosis. In our previous study, we developed a next-generation sequencing technology to detect minimal residual cancer cells in peritoneal lavage fluid with a personalized assay profiling tumor-specific mutations in patients with gastric cancer. With this technology, we predicted all the cases that developed peritoneal metastasis in patients with pT4 disease with 100% sensitivity and 91% specificity. Based on this result, a prospective phase 2 clinical trial is designed to evaluate the efficacy of adjuvant intraperitoneal chemotherapy in patients with positive cancer cell DNA detected in peritoneal lavage fluid by our personalized tumor-specific mutation profiling assay.

Conditions

Interventions

DRUG

Intraperitoneal chemotherapy

5-Fu 1 g/m\^2 on Days 1, 8, 15, and 22; Albumin-paclitaxel 80-100 mg/time on Days 1, 8, 15, and 22; Cisplatin 25 mg/m\^2 on Days 4, 11, 18, and 25; Interleukin-2 2 million units/time on Days 4, 11, 18, and 25.

DRUG

Adjuvant systemic chemotherapy

Oxaliplatin 85 mg/m\^2 on Day 1; S-1 depends on Body Surface Area (BSA), 40 mg Bid, Days 1-10 (BSA \< 1.25 m\^2), 50 mg Bid, Days 1-10 (BSA 1.25-1.50 m\^2), 60 mg Bid, Days 1-10 (BSA \> 1.50 m\^2).

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2024-06-20
Completion
2024-06-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05497739 on ClinicalTrials.gov