Advanced Biliary Tract Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. BTC patients confirmed by pathological reports; 3. There is at least 1 measurable lesion defined according to RECIST v1.1 or a measurable lesion with a clear progression after local treatment (based on RECIST V1.1 standards); 4. Liver function is Child-Pugh Class A; 5. ECOG PS<=1; 5. No obvious blood system and immune system defects; 6. Sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Hepatocellular carcinoma or non-biliary tract tumor metastasis; 2. Tumor lesions cannot be assessed; 3. Have received any targeted, immunotherapy or radiotherapy; 4. Have a history of autoimmune diseases or immunodeficiency; 5. Have received other clinical trials within 4 weeks before the first dose; 6. Female patients who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR);Conversion surgery rate;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Event-free survival;Overall survival; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Zhejiang University School of Medicine