Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC (KN035-BTC)

  • End date
    Jul 30, 2024
  • participants needed
  • sponsor
    3D Medicines (Sichuan) Co., Ltd.
Updated on 14 July 2022
systemic therapy
measurable disease
recurrent disease
metastatic biliary tract carcinoma
biliary tract cancer


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.

Condition Biliary Tract Neoplasms
Treatment KN035 plus Gemcitabine & oxaliplatin, Gemcitabine & oxaliplatin
Clinical Study IdentifierNCT03478488
Sponsor3D Medicines (Sichuan) Co., Ltd.
Last Modified on14 July 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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