Biliary Tract Neoplasms
Conditions
Brief 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.
Interventions
DRUGKN035 plus Gemcitabine & oxaliplatin
KN035 a programmed death ligand immune check inhibitor Per Investigator decision
The standard of care for the patients with unresectable/metastatic biliary tract cancer
Sponsors
3D Medicines (Sichuan) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Observed by 6 weeks | was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent Review Committee (BIRC) review. |
| Objective response rate (ORR) | Observed by 6 weeks | was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on BIRC evaluation. |
| Disease control rate (DCR) | Observed by 6 weeks | was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response or stable disease and was assessed using RECIST 1.1 based on BIRC evaluation |
| Duration of Response (DOR) | Observed by 6 weeks | was defined as the time from the first met for complete response/partial response (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study) |
| Time to progression (TTP) | Observed by 6 weeks | was defined as the time from randomization to the first date that progressive disease was objectively documented |
Countries
China
Outcome results
None listed