NCT07309185

Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy

Adebrelimab Combined With Famitinib Malate and Irinotecan Versus Irinotecan in Patients With Advanced Gastric Cancer After Failure of First-Line Therapy: A Randomized, Controlled, Exploratory Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Shandong Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study employs a randomized, controlled, exploratory clinical trial design, with a planned enrollment of 66 patients who have previously failed systemic chemotherapy for recurrent/metastatic gastric cancer,

Detailed description

Among these, 6 cases were in the safety run-in period, receiving treatment with Adeberlimab combined with Famitinib and Irinotecan. The safety during the first 3 months of medication was observed to determine whether DLT (Dose-Limiting Toxicity) occurred within the treatment cycle. If ≤ 2 subjects experienced DLT, the study would proceed to the extension treatment phase; if \> 2 subjects experienced DLT, the study would be terminated. DLT is defined as the occurrence of any of the following drug-related events during the first treatment cycle: grade 4 hematologic toxicity; grade 3 neutropenia with fever; grade 3 thrombocytopenia with bleeding; or any other grade 3 non-hematologic toxicity (excluding alopecia). After the safety importation period, patients will enter the extended treatment phase, with an additional 60 cases to be enrolled and randomly assigned in a 1:1 ratio to either the experimental group or the control group. The experimental group received treatment with Adeberlimab combined with famitinib maleate and irinotecan until disease progression, intolerable adverse reactions, or death. The control group received irinotecan treatment until disease progression, unacceptable toxicity, or death.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	Adebrelimab	Adebrelimab Injection: 1200mg, i.v.gtt, d1, Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.
DRUG	Irinotecan	Irinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.
DRUG	Malic acid Famitinib	Malic acid Famitinib: 20mg, po, d1-21.

Timeline

• Start date: 2024-07-24
• Primary completion: 2027-07-31
• Completion: 2028-07-31
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China