Status:
ACTIVE_NOT_RECRUITING
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
Lead Sponsor:
3D Medicines (Sichuan) Co., Ltd.
Conditions:
Biliary Tract Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in t...
Eligibility Criteria
Inclusion
- Eighteen years and older;
- Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma;
- Previously untreated with systemic therapy; Subjects who developed recurrent disease \>6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible.
- Liver function Child-Pugh A or B;
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
- Life expectancy of at least 12 weeks;
- At least one measurable lesion per RECIST 1.1;
- Adequate organ function
Exclusion
- Specific anti-tumor treatment prior to 4 weeks;
- more than 50% liver metastasis ;
- Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc;
- History of severe hypersensitivity reaction to any monoclonal antibody or chemistry;
- Women who are pregnant or in the period of lactation;
- Patients with an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement;
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT03478488
Start Date
April 16 2018
End Date
December 31 2026
Last Update
May 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Chinese people's liberation army (PLA) 81hospital
Nanjing, Jiangsu, China, 210002