Safety and Effectiveness of Sequential Cryoablation With Rilafup α and Chemotherapy as First-line Treatment for Intrahepatic Cholangiocarcinoma and Gallbladder Cancer: a Multicenter, Prospective, Single-arm, Phase II Clinical Study
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.
• Age ≥18 years, any gender;
• Histologically confirmed unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma or gallbladder cancer;
• No prior anti-tumor treatment;
• At least one measurable target lesion according to RECIST 1.1 tumor evaluation criteria, and at least one lesion suitable for ablation;
• No active autoimmune disease;
• No concurrent malignancies;
• ECOG performance status 0-1;
• Expected survival ≥ 3 months;
• 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× upper limit of normal (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);
⁃ Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective medical contraception from signing the informed consent until 6 months after the last dose;
⁃ Participants voluntarily join the study, sign the informed consent form, and can comply with scheduled visits and related procedures.