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.
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.
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.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [may be enrolled if stable on hormone replacement therapy]). Patients with childhood asthma that has completely resolved in adulthood without any intervention, or vitiligo, may be enrolled. Patients requiring medical intervention with bronchodilators are not eligible.
Known congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection.
Uncontrolled cardiac clinical symptoms or diseases, e.g., NYHA Class II or above heart failure, unstable angina, myocardial infarction within 1 year, or patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
Single group
Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib
DrugIparomlimab and Tuvonralimab Injection:5 mg/kg, intravenous infusion on Day 1 of each 3-week cycle (q3w); for 4 to 6 cycles. Lenvatinib: 8-12 mg, orally once daily (qd). The dose is determined by body weight:8 mg po qd for body weight \< 60 kg;12 mg po qd for body weight ≥ 60 kg GemOX Regimen: Oxaliplatin: 85 mg/m², intravenous infusion on Day 1 of each 3-week cycle (q3w); for a maximum of 6 cycles. Gemcitabine: 1000 mg/m², intravenous infusion on Day 1 and Day 8 of each 3-week cycle (q3w); for a maximum of 6 cycles. Postoperative Treatment for Patients with Successful Conversion: Iparomlimab and Tuvonralimab Injection: 5 mg/kg, intravenous infusion on Day 1 of each 3-week cycle (q3w); for 8 cycles. For Patients without Successful Conversion: Subsequent treatment regimens will be determined by the investigator.
R0 Resection Rate
Conversion Rate
Objective response rate
the percentage of participants in the analysis population who had a CR(Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) usingRECIST 1.1 based on investigator assessment.
Progression-Free Survival
PFS was defined as the time from first dose of study treatment to the firstdocumented PD per REClST 1.1 by investigator assessment, or death due to any cause, whicheveroccurred first.
pathological Complete Response
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