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Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer

NCT06499610 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-07-12

No results posted yet for this study

Summary

This study is a single-arm, single-center, exploratory clinical study. It is expected that 44 patients with advanced gastric and gastroesophageal junction adenocarcinoma with first-line treatment failure will be included to receive irinotecan liposomes combined with cindilizumab and renvalatinib. The study unit is the First Affiliated Hospital of Xi'an Jiaotong University. The study included screening period (28 days), treatment period (6 cycles), and follow-up period. Subjects signed the informed consent and underwent baseline examination during the screening period, patients meeting the exclusion criteria entered the treatment period, and all subjects completed the protocol to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. The follow-up period begins after the end of the treatment period.

Conditions

Interventions

DRUG

Irinotecan Hydrochloride Liposome Injection

At the dose of 70mg / m2, for patients homozygous for UGT1A1 \* 28, the first dose of irinotecan was adjusted to 50mg / m2,70mg / m2 if the patient tolerated during the first cycle and 70 mg / m 2 in the subsequent cycle; add 500 mL of 5% glucose injection or 0.9% sodium chloride injection for intravenous infusion within 90 minutes. On the first day of each treatment cycle.

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Enxiao Li, doctor · First Affiliated Hospital of Xian Jiaotong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2027-10-15
Completion
2027-10-15

Countries

  • China

Study Locations

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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 NCT06499610 on ClinicalTrials.gov