QL1706 Combined with Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors：A Single - Arm, Open - Label, Multi - Center, Prospective Phase II Clinical Trial (Spring Study)
The patient voluntarily participates in the trial, provides full informed consent, signs a written consent form, and demonstrates good compliance.
The patient is aged 18 or older, regardless of gender.
The patient has a histologically confirmed diagnosis of unresectable locally advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intrahepatic and extrahepatic) and gallbladder cancer.
The patient is newly diagnosed with unresectable locally advanced or metastatic biliary tract cancer and has not received prior systemic therapy.
Cholangiocarcinoma of rare histopathological types confirmed by histology or cytology, such as ampullary cancer, small cell cancer, neuroendocrine tumors, sarcoma, and mucinous cystic tumors.
Subjects with other malignancies within 5 years before enrollment, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been cured.
History of leptomeningeal carcinoma, brain metastasis.
Participation in another interventional clinical study within the past 3 months, or concurrent enrollment in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study.
Single group
QL1706
DrugEligible participants will receive QL1706 at 5.0 mg/kg intravenously every 3 weeks, lenvatinib at 8 mg orally once daily every 3 weeks, oxaliplatin at 85 mg/m², and gemcitabine at 1000 mg/m² (on days 1 and 8 of each cycle) for up to 8 cycles. Then, they will continue with QL1706 and lenvatinib until clinical progression, imaging progression per RECIST 1.1, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met.
Objective Response Rate (ORR)
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Disease Control Rate (DCR)
DCR was assessed by investigators per RECIST 1.1
Time to Response (TTR)
TTR was assessed by investigators per RECIST 1.1
Duration of Response (DOR)
DOR was assessed by investigators per RECIST 1.1
Progression-free Survival (PFS)
PFS was assessed by investigators per RECIST 1.1
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