Study on Sequential Cryoablation, Relaforp Alpha, and Chemotherapy for Bile Duct Tumors

NCT07726446 | Recruiting Phase 2

• 1 other identifier: E20260847
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biliary Tract Cancer (BTC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  ORR

  1 year

Secondary Outcomes (6)

• Objective response rate in the subgroup

  1 year

• disease control rate

  1 year

• Progression-free survival

  2 years

• Overall survival

  2 years

• Duration of Response

  1 year

Study Arms (1)

Ablation combined with chemo and immunotherapy

EXPERIMENTAL

Drug: PD-1 and chemotherapy; Procedure: cryoablation

Interventions

PD-1 and chemotherapy DRUG

Rilapafup α: 1800 mg, intravenous infusion, every 3 weeks. Use Rilapafup α injection (same dose as above) for maintenance therapy until disease progression or unacceptable toxicity occurs. Chemotherapy: Gemcitabine 1000 mg/m² IV infusion over 30 minutes on days 1 and 8; Cisplatin 25 mg/m² IV infusion on days 1 and 8; repeat every 3 weeks.

Ablation combined with chemo and immunotherapy

cryoablation PROCEDURE

Cryoablation: Depending on the size and location of the tumor, a cryoprobe is inserted percutaneously into the center of the tumor under ultrasound guidance. Once the probe is in place, the tip is cooled down to -196℃, freezing the tumor for 15 minutes, then warmed up (to about 80℃) for 5 minutes, completing two freeze-thaw cycles.

Ablation combined with chemo and immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previously received systemic anti-tumor treatment;
• 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;
• 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.);
• Allergic to the study drug (Rilafup Alpha Injection, or other immune checkpoint inhibitors);
• 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;
• Urinalysis showing protein ≥ and confirmed 24-hour urine protein quantification \> 1.0g;
• 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;
• Currently participating in interventional clinical research treatment, or have received other study drugs or devices within 4 weeks before first administration;
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

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, 300060, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Drug Therapy; Cryosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Tianqiang T Song, MD

CONTACT

18622221077; tjchi@hotmail.com

Liyu L Sun

CONTACT

17860489096

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)