Sequential Cryoablation, Relatlimab alfa, and Chemotherapy for Bile Duct Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm Phase II study enrolling up to 30 adults with unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma or gallbladder cancer. Participants receive cryoablation first, followed by eight cycles of Relatlimab alfa plus GC chemotherapy every three weeks, then maintenance Relatlimab alfa alone for up to one year. Efficacy is assessed every six weeks during combination therapy and at six-to-nine week intervals during maintenance. Survival follow-up occurs every three months for two years, then every six months until study end or death. The study aims to determine safety and preliminary efficacy of this sequential approach in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years, any gender;
2. Histologically confirmed unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma or gallbladder cancer;
3. No prior anti-tumor treatment;
4. At least one measurable target lesion according to RECIST 1.1 tumor evaluation criteria, and at least one lesion suitable for ablation;
5. No active autoimmune disease;
6. No concurrent malignancies;
7. ECOG performance status 0-1;
8. Expected survival ≥ 3 months;
9. Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks before first dose), defined as:

   1. Blood count: neutrophils (NEUT) ≥ 1.2×10\^9/L; platelets (PLT) ≥ 90×10\^9/L; hemoglobin ≥ 90 g/dL;
   2. 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;
   3. INR ≤ 1.25;
   4. Serum creatinine ≤ 1.5× ULN or creatinine clearance (CrCl) ≥ 30 mL/min (using Cockcroft-Gault formula);
10. 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;
11. Participants voluntarily join the study, sign the informed consent form, and can comply with scheduled visits and related procedures.

Exclusion Criteria:

1. Previously received systemic anti-tumor treatment;
2. Active brain metastases; patients with asymptomatic brain metastases can be enrolled; for patients clinically suspected of central nervous system metastasis, a CT or MRI must be performed within 28 days before enrollment to rule out central nervous system metastasis;
3. Had other malignant tumors within 5 years before administration (except tumors cured with radical treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.);
4. Allergic to the study drug (Rilafup Alpha Injection, or other immune checkpoint inhibitors);
5. History of unstable angina; newly diagnosed angina within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmias (including QTcF: men ≥ 450 ms, women ≥ 470 ms) requiring long-term use of anti-arrhythmic drugs and NYHA class ≥ II heart failure;
6. Urinalysis showing protein ≥ and confirmed 24-hour urine protein quantification \> 1.0g;
7. Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, or other conditions requiring corticosteroid therapy; history of chronic autoimmune diseases, such as systemic lupus erythematosus; history of ulcerative colitis, Crohn's disease, or other inflammatory bowel diseases; history of chronic diarrhea conditions like irritable bowel syndrome; history of sarcoidosis or tuberculosis; active hepatitis B or C, and HIV infection;
8. Currently participating in interventional clinical research treatment, or have received other study drugs or devices within 4 weeks before first administration;
9. History of substance abuse that cannot be stopped or mental disorders; Any other situation in which the investigator believes the patient is not suitable for participation in this study.

Where it's running

• Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, Key Laboratory of Cancer Prevention and Therapy, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Tianjin, 300060, China
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Tianqiang T Song, MD
• Email: tjchi@hotmail.com
• Phone: 18622221077

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.