SHR-1210 in Combination With GEMOX in Patients With Advanced BTC

Study Overview
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Brief Summary
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This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies. In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled. 28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity.

Official Title
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A Single-arm, Open-label and Exploratory Clinical Study of PD-1 Monoclonal Antibody SHR-1210 in Combination With GEMOX (Gemcitabine Combined Oxaliplatin) in Patients With Advanced Biliary Tract Cancer

Conditions
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Biliary Tract Cancer, Cholangiocarcinoma

Intervention / Treatment
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* Drug: SHR-1210+GEMOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathology confirmed biliary malignancy, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma. Age:18-75 years, male or female. The estimated survival period is more than 3 months. ECOG 0-1. There is at least one measurable lesion, according to the RECIST 1.1 standard. Patients has not been treated by oxaliplatin, gemcitabine and pd-1 / pd-l1 antibody. Patients who have been treated tegafur or capecitabine as adjuvant chemotherapy or first-line treatment may be selected. Exclusion Criteria: There were concurrent malignant tumors, except for the cured skin basal cell carcinoma and cervical carcinoma in situ. Other drug clinical trials have been taken in four weeks. Patients with a history of central nervous system metastasis or central nervous system metastasis are known before the screening. Patients with a history of unstable angina. The urine routine indicated that the urine protein was greater than ++ and confirmed the 24-hour urine protein quantification >1.0 g. Have used immune-targeted therapy drugs. The patient had received a liver transplant. Having a history of chronic autoimmune diseases such as systemic lupus erythematosus. Having a history of immunodeficiency, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR1210+GEMOX<br>This is a single arm trial. Participants will receive SHR1210 + GEMOX treatment. | Drug: SHR-1210+GEMOX<br>* 28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond chemotherapy until the disease progression or untolerable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month Progression Free Survival (PFS) rate | the rate of 6-month progression free survival | from the first drug administration up to 6 months | 
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events | from the first drug administration to within 90 days for the last SHR-1210 dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | the best Objective Response Rate | from the first drug administration up to two years | 
| Duration of response (DOR) | Duration of response | from the first drug administration up to two years | 
| Disease Control Rate (DCR) | the Rate of Disease Control | from the first drug administration up to two years | 
| 12-month Overall survival (OS) rate | Overall Survival rate at 12 months | from the first drug administration up to approximately 12 months | 
| OS | Overall survival | from the first drug administration up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BTC, PD-1 antibody