Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
- Conditions
- Biliary Tract Neoplasms
- Registration Number
- NCT03478488
- Lead Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 480
Inclusion Criteria:<br><br> - Eighteen years and older;<br><br> - Histological or cytological diagnosis of unresectable or metastatic gallbladder<br> cancer or cholangiocarcinoma;<br><br> - Previously untreated with systemic therapy; Subjects who developed recurrent disease<br> >6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible.<br><br> - Liver function Child-Pugh A or B;<br><br> - Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)<br> Performance Status;<br><br> - Life expectancy of at least 12 weeks;<br><br> - At least one measurable lesion per RECIST 1.1;<br><br> - Adequate organ function<br><br>Exclusion Criteria:<br><br> - Specific anti-tumor treatment prior to 4 weeks;<br><br> - more than 50% liver metastasis ;<br><br> - Patient with other serious diseases or clinical conditions, including but not<br> limited to uncontrolled active infection etc;<br><br> - History of severe hypersensitivity reaction to any monoclonal antibody or chemistry;<br><br> - Women who are pregnant or in the period of lactation;<br><br> - Patients with an active, known or suspected autoimmune disease. Patients are<br> permitted to enrol if they have vitiligo, type I diabetes mellitus, residual<br> hypothyroidism due to autoimmune condition only requiring hormone replacement;
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS);Objective response rate (ORR);Disease control rate (DCR);Duration of Response (DOR);Time to progression (TTP)