drugset / Trial / NCT06499610

Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer

NCT06499610

Phase 4 Not yet recruiting 44 enrolled First Affiliated Hospital Xi'an Jiaotong University
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 70 mg/m2 Intravenous
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Sintilimab Monoclonal antibody 200 mg Intravenous

Indications