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Efficacy and Safety of Sintilimab Combined With Lenvatinib and HAIC for Neoadjuvant Therapy of Borderline Resectable HCC

NCT06904014 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-01

No results posted yet for this study

Summary

This study is a single-center, randomized controlled exploratory Phase II clinical trial, aiming to assess the efficacy and safety of sintilimab combined with lenvatinib and HAIC for two cycles followed by surgery compared with direct surgery in patients with borderline resectable hepatocellular carcinoma.

After signing the informed consent and meeting the inclusion and exclusion criteria, the eligible subjects were randomly divided into the experimental group and the control group:

* Subjects in the experimental group received 200 mg of sintilimab by intravenous infusion on the first day of every 3 weeks. Lenvatinib 8 mg was orally administered once daily, combined with the HAIC-FOLFOX regimen. After two cycles, the patients' conditions were evaluated for surgery.
* Subjects in the control group underwent surgery directly.

Both groups of subjects received sintilimab monotherapy as adjuvant treatment for half a year (a total of 8 cycles) after surgery. The treatment was terminated if there was disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or other reasons stipulated in the protocol.

Conditions

Interventions

PROCEDURE

HAIC

FOLFOX-hepatic artery infusion

DRUG

Sintilimab

200mg, ivgtt, D1, Q3W

DRUG

Lenvatinib

8 mg，qd，D1-D21,Q3W

PROCEDURE

surgery

surgery

Sponsors & Collaborators

  • Lei ZHAO

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2027-06-30
Completion
2029-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06904014 on ClinicalTrials.gov