OncoMatch/Clinical Trials/NCT07726446
Study on Sequential Cryoablation, Relaforp Alpha, and Chemotherapy for Bile Duct Tumors
Is NCT07726446 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies PD-1 and chemotherapy for biliary tract cancer (btc).
Treatment: PD-1 and chemotherapy — This study is a prospective, multicenter, single-arm, open-label Phase II clinical trial, planned to enroll 30 patients with unresectable locally advanced or metastatic iCCA/GBC. Patients will first receive cryoablation treatment, and two weeks after ablation, they will receive 8 cycles of immunotherapy combined with chemotherapy (Relatlimab α plus GC chemotherapy, every 3 weeks). During the maintenance phase, patients will continue with Relatlimab α alone, every 3 weeks, for up to one year. During the combination treatment phase, efficacy will be evaluated every 6 weeks, and during the maintenance phase, every 6 to 9 weeks. From the date of randomization/enrollment, survival follow-ups will be conducted every 3 months (±14 days) for the first 2 years; afterwards, follow-ups will occur every 6 months (±28 days) until the participant dies, is lost to follow-up, or the study ends, whichever comes first.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor treatment
No prior anti-tumor treatment; Previously received systemic anti-tumor treatment
Lab requirements
Blood counts
neutrophils (NEUT) ≥ 1.2×10^9/L; platelets (PLT) ≥ 90×10^9/L; hemoglobin ≥ 90 g/dL
Kidney function
Serum creatinine ≤ 1.5× ULN or creatinine clearance (CrCl) ≥ 30 mL/min (using Cockcroft-Gault formula)
Liver function
AST and ALT ≤ 2.5× ULN; ALP ≤ 2.5×ULN; total bilirubin (TBIL) ≤ 1.5×ULN; if liver metastases, ALT and AST ≤ 5×ULN
Cardiac function
INR ≤ 1.25; exclusion for unstable angina, recent MI, arrhythmias requiring long-term anti-arrhythmic drugs, NYHA class ≥ II heart failure
Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks before first dose), defined as: Blood count: neutrophils (NEUT) ≥ 1.2×10^9/L; platelets (PLT) ≥ 90×10^9/L; hemoglobin ≥ 90 g/dL; Liver function: AST and ALT ≤ 2.5× ULN; ALP ≤ 2.5×ULN; total bilirubin (TBIL) ≤ 1.5×ULN; if liver metastases, ALT and AST ≤ 5×ULN; INR ≤ 1.25; Serum creatinine ≤ 1.5× ULN or creatinine clearance (CrCl) ≥ 30 mL/min (using Cockcroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07726446 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.
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