NCT06437678

Phase II Study of Liposomal Irinotecan for Advanced Refractory Gastric Cancer

A Single-Center, Prospective Phase II Clinical Study of Liposomal Irinotecan Monotherapy for Third-Line and Beyond Recurrent/Refractory Advanced Gastric Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the objective response rate (ORR) and disease control rate (DCR) of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer.

Detailed description

This study is a single-arm, single-center, prospective clinical trial aimed at evaluating the efficacy and safety of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer. The study targets patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. The primary endpoints of the study are objective response rate (ORR) and disease control rate (DCR). It plans to enroll 50 patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. Subjects will sign informed consent and undergo screening for eligibility before enrollment. Subjects will receive the following treatment: Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks. Safety visits will be conducted on Day 1 of each treatment cycle, at the end of the study treatment, and 30 days (±7 days) after the end of the study treatment. Imaging assessments will be performed according to RECIST 1.1 criteria, including chest CT, enhanced CT scans of the abdomen and pelvis, or chest CT plain scan plus abdominal/pelvic MRI scan for patients allergic to contrast agents. Suspected cases of brain metastases will require brain enhanced MRI or enhanced CT. Bone scan examination will be conducted if bone metastases are suspected clinically or radiologically. Patients who discontinue treatment due to reasons other than radiological progression during the treatment period will undergo imaging examination at the end of treatment unless it has been conducted within 28 days. Subjects will undergo survival follow-up every 3 months after the end of treatment to collect and record survival status and subsequent anti-tumor treatment until death or loss to follow-up.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Liposomal Irinotecan Hydrochloride	Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks

Timeline

• Start date: 2024-05-27
• Primary completion: 2025-02-28
• Completion: 2026-02-28
• First posted: 2024-05-31
• Last updated: 2024-05-31

Locations

1 site across 1 country: China