Trials / Active Not Recruiting
Active Not RecruitingNCT03478488
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KN035 plus Gemcitabine & oxaliplatin | KN035 a programmed death ligand immune check inhibitor Per Investigator decision |
| DRUG | Gemcitabine & oxaliplatin | The standard of care for the patients with unresectable/metastatic biliary tract cancer |
Timeline
- Start date
- 2018-04-16
- Primary completion
- 2024-09-10
- Completion
- 2026-12-31
- First posted
- 2018-03-27
- Last updated
- 2025-05-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03478488. Inclusion in this directory is not an endorsement.