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Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

NCT05010668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-02-21

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with advanced intrahepatic Cholangiocarcinoma after progression on first line systemic therapy.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

DRUG

cryoablation

Cryoablation treatment starts at day 0.

DRUG

Sintilimab

Sintilimab will be initiated on day 14 after cryoablation. Sintilimab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

DRUG

lenvatinib

Lenvatinib will be initiated on day 14 after cryoablation. Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Peng Wang, MD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2024-03-02
Completion
2024-03-02

Countries

  • China

Study Locations

More Related Trials

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 NCT05010668 on ClinicalTrials.gov