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RecruitingPhase 2NCT06892925

QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors

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Trial Parameters

ConditionBiliary Tract Tumors
SponsorEastern Hepatobiliary Surgery Hospital
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment59
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-06-14
Completion2026-04
Interventions
QL1706

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Brief Summary

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)

Eligibility Criteria

Inclusion Criteria: 1. The patient voluntarily participates in the trial, provides full informed consent, signs a written consent form, and demonstrates good compliance. 2. The patient is aged 18 or older, regardless of gender. 3. The patient has a histologically confirmed diagnosis of unresectable locally advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intrahepatic and extrahepatic) and gallbladder cancer. 4. The patient is newly diagnosed with unresectable locally advanced or metastatic biliary tract cancer and has not received prior systemic therapy. 5. Patients who have previously received radical treatment (surgery, adjuvant chemotherapy, and/or radiotherapy) are allowed, provided disease recurrence is \>6 months after treatment. Those who received adjuvant therapy (chemotherapy and/or radiotherapy) and are \>6 months post-treatment are also eligible. 6. At baseline, the patient has at least one measurable lesion according to RECIST v1.1 that can be repe

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