MedTrace Logo

Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for Advanced HCC

NCT05985798 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2023-08-14

No results posted yet for this study

Summary

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus TACE (Sin-Bev-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced stage hepatocellular carcinoma (HCC).

Conditions

  • Hepatocellular Carcinoma Non-resectable

Interventions

DRUG

Sin-Bev-TACE

Sintilimab (200mg I.V. q3w) and bevacizumab (7.5mg/kg I.V. q3w) are administered at 3-7 days after the first TACE. The study treatment of sintilimab and bevacizumab will last up to 24 months. TACE can be repeated on demand.

DRUG

Len-TACE

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated on demand.

Sponsors & Collaborators

  • Affiliated Hospital of Guangdong Medical University

    collaborator OTHER

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Lecong Hospital, Shunde District, Foshan

    collaborator UNKNOWN

  • First People's Hospital of Foshan

    collaborator OTHER

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    collaborator OTHER

  • Second Affiliated Hospital of Guangzhou Medical 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
2023-08-01
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

More Related Trials

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 NCT05985798 on ClinicalTrials.gov