Overview

Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC

Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
3D Medicines (Sichuan) Co., Ltd.
Treatments:
Gemcitabine
Oxaliplatin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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;