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TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC

NCT05250843 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-10-13

No results posted yet for this study

Summary

The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

Conditions

Interventions

PROCEDURE

TACE/HAIC

Within 1-3 days of lenvatinib and sintilimab, start Transarterial chemobolization treatment or FOLFOX-based chemotherapy infusion,after three months,patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection.

DRUG

Lenvatinib

Participants received lenvatinib capsules 8mg for patients weight \<60kg, or 12mg for patients weight more than 60Kg.

DRUG

Sintilimab

Sintilimab Injection will be administered every three weeks (200mg) until surgery or disease progression.

PROCEDURE

liver resection

liver resection is feasible after evaluation by the liver cancer surgery expert group

Sponsors & Collaborators

  • Third Affiliated Hospital, Sun Yat-Sen University

    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
2022-05-30
Primary Completion
2023-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

More Related Trials

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 NCT05250843 on ClinicalTrials.gov