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Gallbladder Cancer

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Gemcitabine

Oxaliplatin

Camrelizumab plus GEMOX was given as conversion therapy for unresectable gallbladder cancer

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.

Camrelizumab plus GEMOX

Zhang Rui, PhD

Ye Yanfang

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.

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

The proportion of patients with negative surgical resection margins in the study group

The proportion of patients whose tumours shrink or remain stable for a certain period of time and includes cases of complete remission (CR), partial remission (PR) and stable (SD).

The time between the start of treatment for disease and the observation of disease progression or the occurrence of death from any cause

The time between the start of the diagnosis of unresectable gallbladder cancerand death from any cause

The proportion of patients whose tumour volume shrinks to a pre-defined value and who are able to maintain the minimum time requirement is the sum of the proportion in complete remission (CR) and partial remission (PR)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs	NCT06423170	Unresectable Ga...	Camrelizumab pl...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs	NCT06423170	Unresectable Ga...	Camrelizumab pl...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs	NCT06423170	Unresectable Ga...	Camrelizumab pl...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for camrelizumab plus gemox