For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Eighteen years and older;
  2. Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma;
  3. Previously untreated with systemic therapy; Subjects who developed recurrent disease >6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible.
  4. Liver function Child-Pugh A or B;
  5. Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
  6. Life expectancy of at least 12 weeks;
  7. At least one measurable lesion per RECIST 1.1;
  8. Adequate organ function

EXCLUSION CRITERIA

  1. Specific anti-tumor treatment prior to 4 weeks;
  2. more than 50% liver metastasis ;
  3. Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc;
  4. History of severe hypersensitivity reaction to any monoclonal antibody or chemistry;
  5. Women who are pregnant or in the period of lactation;
  6. 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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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +86(10) 64882533Email iconEmail Study Center

Study’s details


Contition

Biliary Tract Neoplasms

Age

18+

Phase

Phase 3

Participants needed

480

Est. Completion Date

Jul 2024

Treatment type

Interventional


Sponsor

3D Medicines

ClinicalTrials.gov identifier

NCT03478488

Study number

KN035-CN-005

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