MedTrace Logo

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

NCT07726446 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-24

No results posted yet for this study

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)

Interventions

DRUG

PD-1 and chemotherapy

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.

PROCEDURE

cryoablation

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-10-31
Completion
2030-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07726446 on ClinicalTrials.gov