Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy f… (NCT07263360) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
China29 participantsStarted 2026-02-01
Plain-language summary
The primary objective is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) combined with GemOX and lenvatinib as conversion therapy for Initially Potentially Resectable intrahepatic cholangiocarcinoma and gallbladder cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years, male or female.
* Histologically or cytologically confirmed diagnosis of locally advanced or potentially resectable intrahepatic cholangiocarcinoma or gallbladder cancer, defined as T2b-T4 or N1 M0 according to the AJCC 8th edition.
* Expected life expectancy ≥ 12 weeks.
* No prior systemic treatment for biliary tract cancer before the first dose of study medication.
* At least one measurable lesion as defined by RECIST 1.1 criteria.
* ECOG Performance Status of 0 or 1.
* Adequate organ function, without severe dysfunction of the hematologic, cardiac, pulmonary, hepatic, renal, bone marrow, or immune systems.
* Laboratory tests meeting the following requirements: Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug. For men, they must be surgically sterile or agree to use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug.
* Patient voluntarily participates and provides written informed consent.
* Good compliance is anticipated, allowing for efficacy and adverse event follow-up per the protocol.
Exclusion Criteria:
* The subject has received any prior antitumor therapy or any investigational anticancer agents.
* Presence of any active autoimmune disease or a history of autoimmune diseases (e.…
What they're measuring
1
R0 Resection Rate
Timeframe: up to 12 month
Trial details
NCT IDNCT07263360
SponsorTianjin Medical University Cancer Institute and Hospital