NCT03478488CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 472 (actual)
- First submitted
- 21 Mar 2018
- Start date
- 16 Apr 2018
- Primary completion date
- 10 Sept 2024
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT03478488
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 472
- From 16 Apr 2018 to the primary completion date, 10 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Specific anti-tumor treatment prior to 4 weeks;
Other illness
- 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;
- 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;
Other
- more than 50% liver metastasis ;
- Women who are pregnant or in the period of lactation;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese people's liberation army (PLA) 81hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.