NCT06423170

A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs

Camrelizumab Plus Gemcitabine and Oxaliplatin (GEMOX) in Patients for Unresectable Gallbladder Cancer: a Single-arm, Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the efficacy and safety of Camrelizumab combined with gemcitabine and oxaliplatin (GEMOX) for unresectable gallbladder cancer. Patients with unresectable gallbladder cancer were enrolled to receive gemcitabine 1000mg/m2 D1+oxaliplatin 100mg/m2, D1+Camrelizumab 200mg, D1, in 21-day cycles for 6-8 cycles, with serum tumour markers assessed at each course and abdominal CTA performed every two courses, until tumour progression occurs.The primary indicators of this study are radical tumor resection rate; secondary indicators are disease control rate, objective response rate,progression-free survival and overall survival; safety indicators: incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAEv5.0 criteria. 37 patients are expected to be recruited for this study.

Conditions

• Unresectable Gallbladder Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab plus GEMOX	1. Camrelizumab：200mg，D1，intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : oxaliplatin 100mg/m2，D1, gemcitabine1000mg/m2，D1，intravenous infusion. 3. Carrilizumab and GEMOX chemotherapy will be intravenous infused atone day. Three weeks is a course of treatment,a total of 6-8 courses.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-05-21
• Last updated: 2024-05-21

Locations

1 site across 1 country: China