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Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma

NCT07070700 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-08-12

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus QL1706 (iparomlimab/tuvonralimab) in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.

Conditions

  • Intrahepatic Cholangiocarcinoma (Icc)

Interventions

DRUG

QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

QL1706 will be administered by IV, 5 mg/kg on day 1 of each 21 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

DRUG

Lenvatinib

Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

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 QL1706 will be administered 1-3 days after cryoablation.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2027-08-01
Completion
2027-08-01

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 NCT07070700 on ClinicalTrials.gov