OncoMatch/Clinical Trials/NCT07733115
QL1706（Iparomlimab/Tuvonralimab) Combined With Gemcitabine and Cisplatin as First-Line Treatment for PD-L1-Positive Biliary Tract Cancer
Is NCT07733115 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Iparomlimab and Tuvonralimab (QL1706) and Gemcitabine and Cisplatin Chemotherapy for biliary tract cancer (btc).
Treatment: Iparomlimab and Tuvonralimab (QL1706) · Gemcitabine and Cisplatin Chemotherapy — The goal of this clinical trial is to evaluate whether QL1706(Iparomlimab/Tuvonralimab) in combination with gemcitabine and cisplatin (GC) is effective and safe as a first-line treatment for patients with advanced biliary tract cancer whose tumors are PD-L1 positive (CPS ≥ 1). This is a multicenter, single-arm, phase II clinical study. A total of 38 eligible patients will be enrolled . The main questions it aims to answer are: what proportion of patients achieve objective response (tumor shrinkage) after receiving QL1706 plus GC, as measured by the objective response rate (ORR)? How long do the treatment benefits last, in terms of disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS)? What is the safety profile of QL1706 combined with GC, including the frequency and severity of adverse events, treatment-related adverse events, serious adverse events, and immune-related adverse events? Participants will receive QL1706 (5 mg/kg, intravenous infusion) once every 3 weeks in combination with gemcitabine (1000 mg/m² on days 1 and 8) and cisplatin (25 mg/m² on days 1 and 8) for up to 8 cycles (each cycle is 3 weeks), and after completing 8 cycles of combination therapy, they will continue QL1706 alone as maintenance therapy (5 mg/kg once every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, or completion of 2 years of treatment, whichever occurs first. Participants will undergo tumor imaging assessments (using CT or MRI) every 9 weeks (±7 days) during the treatment period, with responses evaluated . Participants will also have regular blood tests, physical examinations, electrocardiograms, and other safety assessments at each treatment cycle, and will provide tumor tissue and blood samples before treatment and at various time points during the study for biomarker analyses to explore correlations with treatment response. Finally, participants will be followed for adverse events for 30 days after the last dose, for serious adverse events for 90 days after the last dose, and for survival status every 90 days (±14 days) after the end of treatment until death, study completion, or loss to follow-up. The study is expected to provide valuable evidence on whether the addition of QL1706 to standard GC chemotherapy offers a new treatment option for patients with PD-L1-positive advanced biliary tract cancer, and to identify potential biomarkers that may help predict which patients are most likely to benefit from this combination therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: PD-L1 (CD274) overexpression (CPS ≥ 1)
PD-L1-positive tumor (Combined Positive Score [CPS] ≥ 1)
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG PS score of 0 or 1
Demographics
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior treatment with anti-PD-1/PD-L1 agents
Cannot have received: anti-PD-L1 therapy
Prior treatment with anti-PD-1/PD-L1 agents
Cannot have received: anti-CTLA-4 therapy
Prior treatment with anti-CTLA-4 agents
Cannot have received: antitumor immunotherapy
Prior treatment with ... other antitumor immunotherapies
Cannot have received: cytotoxic chemotherapy
Exception: adjuvant therapy completed >6 months before relapse
No prior systemic therapy (chemotherapy, targeted therapy, or immunotherapy). Patients who relapse more than 6 months after curative surgery, and if they have received adjuvant therapy (chemotherapy and/or radiotherapy), relapse more than 6 months after completion of adjuvant therapy, are eligible.
Cannot have received: targeted therapy
Exception: adjuvant therapy completed >6 months before relapse
No prior systemic therapy (chemotherapy, targeted therapy, or immunotherapy). Patients who relapse more than 6 months after curative surgery, and if they have received adjuvant therapy (chemotherapy and/or radiotherapy), relapse more than 6 months after completion of adjuvant therapy, are eligible.
Cannot have received: immunotherapy
Exception: adjuvant therapy completed >6 months before relapse
No prior systemic therapy (chemotherapy, targeted therapy, or immunotherapy). Patients who relapse more than 6 months after curative surgery, and if they have received adjuvant therapy (chemotherapy and/or radiotherapy), relapse more than 6 months after completion of adjuvant therapy, are eligible.
Lab requirements
Blood counts
ANC ≥ 1.5×10⁹/L; Platelet count ≥ 100×10⁹/L; Hemoglobin > 9 g/dL
Kidney function
Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min
Liver function
Total Bilirubin (TBIL) ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN
Cardiac function
Cardiac enzymes within normal limits (isolated laboratory abnormalities deemed clinically insignificant by the investigator are allowed)
Have adequate organ and bone marrow function. ... Laboratory test results ... meet the following requirements. ... Hematology: ANC ≥ 1.5×10⁹/L; Platelet (PLT) count ≥ 100×10⁹/L; Hemoglobin (HGB) > 9 g/dL. Liver function: Total Bilirubin (TBIL) ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN. Renal function: Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min. Thyroid function: TSH within normal range. ... Cardiac enzymes: Within normal limits (isolated laboratory abnormalities deemed clinically insignificant by the investigator are allowed).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07733115 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages