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Trial Title:
AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer
NCT ID:
NCT06591520
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Cisplatin
Gemcitabine
Durvalumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
AK112, Gemcitabine, Cisplatin
Description:
AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W).
Gemcitabine will be administered at 1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8
cycles. Cisplatin will be administered at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8
cycles.
Arm group label:
AK112 + Gemcitabine + Cisplatin
Intervention type:
Drug
Intervention name:
Durvalumab, Gemcitabine, Cisplatin
Description:
Durvalumab will be administered at 1500mg intravenously (IV) every three weeks (Q3W) for
8 cycles and followed by monotherapy every 4 weeks. Gemcitabine will be administered at
1000 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles. Cisplatin will be administered
at 25 mg/m2, D1, D8, Q3W, intravenously (IV) for 8 cycles.
Arm group label:
Durvalumab + Gemcitabine + Cisplatin
Summary:
This is a phase 3 study. All subjects are patients with unresectable locally advanced or
metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG)
performance status 0-1. The purpose of this study is to evaluate the efficacy and safety
of AK112 in combination with chemotherapy versus durvalumab in combination with
chemotherapy in patients with unresectable locally advanced or metastatic BTC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Be able and willing to provide written informed consent.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of at least 3 months.
- Has a histologically or cytologically confirmed diagnosis of biliary tract cancer
(BTC).
- Has no prior systemic anti-tumor therapy for unresectable locally advanced or
metastatic BTC.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1.
- Has adequate organ function.
Exclusion Criteria:
- Has other malignancies within 5 years prior to enrollment.
- Is currently participating in a study of an investigational agent or using an
investigational device.
- Has known active central nervous system (CNS) metastases.
- Has an active autoimmune disease that has required systemic treatment in the past 2
years.
- Has an active infection requiring systemic therapy.
- Has known active Hepatitis B or Hepatitis C.
- History of myocardial infarction, unstable angina, congestive heart failure within
12 months prior to enrollment.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.
- Has received a live virus vaccine within 30 days of the planned first dose of study
therapy.
- Has any concurrent medical condition that, in the opinion of the Investigator, would
complicate or compromise compliance with the study or the well-being of the subject.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Contact:
Last name:
Tongsen Zheng
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Jian Zhou
Start date:
October 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06591520
