NCT06499610

Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer

Prospective, Open-label, Single-arm Clinical Study of Irinotecan Liposomes Combined With Cindilizumab and Lunvalatinib as Second-line Treatment for Adenocarcinoma of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is an exploratory clinical study. It is expected to include 44 patients with second-line advanced gastric and gastroesophageal junction adenocarcinoma, all treated with irinotecan liposome combined with cindilizumab and lunvatinib. The dosing regimen of irinotecan liplex injection was 70 mg / m2, cindilizmab 200mg, and valatinib 8-12mg (dose determined by body weight), every 3 weeks, every 2 treatment cycles (every 6 weeks). The subject is scheduled to receive 6 cycles of treatment, or develop intolerable toxicity, or terminate the study for other reasons. The study included screening period (within 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

• Gastric Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-15
• Primary completion: 2027-10-15
• Completion: 2027-10-15
• First posted: 2024-07-12
• Last updated: 2024-07-12

Locations

1 site across 1 country: China