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Cryoablation Combined With Lenvatinib Plus Tislelizumab Compared With FOLFOX in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-01)

NCT06860477 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-04-06

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus Tislelizumab compared with FOLFOX in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.

Conditions

  • Intrahepatic Cholangiocellular Carcinoma

Interventions

DRUG

Tislelizumab

Tislelizumab will be administered by IV, 200 mg on day 1 of each 21 day cycle.

DRUG

Lenvatinib

Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily

PROCEDURE

cryoablation

Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone. Lenvatinib plus Tislelizumab will be administered 1-3 days after cryoablation.

DRUG

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

FOLFOX chemotherapy was administered intravenously every 2 weeks for a maximum of 12 cycles (oxaliplatin 85 mg/m², leucovorin, 400 mg/m2, fluorouracil 400 mg/m² \[bolus\], and fluorouracil 2400 mg/m² as a 46-h continuous intravenous infusion

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2027-03-15
Completion
2028-03-15

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT06860477 on ClinicalTrials.gov