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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab plus GEMOX | Experimental | Camrelizumab plus GEMOX was given as conversion therapy for unresectable gallbladder cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab plus GEMOX | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| radical tumor resection rate | The proportion of patients with negative surgical resection margins in the study group | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate,DCR | 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). | 6 months |
| Progress Free Survival,PFS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Rui, PhD | Contact | 020-34078840 | zhangr95@mail.sysu.edu.cn | |
| Ye Yanfang | Contact | 02081332587 | sysyxllwyh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhang Rui, PhD | Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510288 | China |
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|
The time between the start of treatment for disease and the observation of disease progression or the occurrence of death from any cause
| 6 months |
| Overall Survival,OS | The time between the start of the diagnosis of unresectable gallbladder cancerand death from any cause | 6 months |
| Objective response rate,ORR | 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) | 6 months |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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