RecruitingPhase 2NCT06423170

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


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

37 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of an immunotherapy drug (camrelizumab) and chemotherapy (gemcitabine and oxaliplatin) is safe and effective for people with gallbladder cancer that cannot be removed by surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with gallbladder cancer that cannot be surgically removed - You have never had chemotherapy or immunotherapy before - You are in reasonably good overall health (able to carry out light activities) - Your liver, kidneys, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have had another type of cancer (with some exceptions like treated skin cancer) - You have uncontrolled high blood pressure - You have severe heart, lung, or kidney problems - You are pregnant or breastfeeding - You have active HIV, hepatitis B, or tuberculosis - You have had gemcitabine-based chemo or a PD-1/PD-L1 immunotherapy drug in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab 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.


Locations(1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06423170