KN035 plus Gemcitabine & oxaliplatinGemcitabine & oxaliplatin
KN035 plus Gemcitabine & oxaliplatin: KN035 a programmed death ligand immune check inhibitor Per Investigator decision
Gemcitabine & oxaliplatin: The standard of care for the patients with unresectable/metastatic biliary tract cancer
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;
Primary outcome measure(s)
Overall Survival (OS) — Observed by 12 weeks after progressive disease or end of treatment was defined as the time from randomization to death due to any cause.
Trial sites (1)
Facility
City
Region
Status
The Chinese people's liberation army (PLA) 81hospital
Nanjing
Jiangsu
More 3D Medicines (Sichuan) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.