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Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients

NCT05213221 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-06-13

No results posted yet for this study

Summary

This study is a single-center, open, single-arm, phase II clinical trial. Eligible HCC patients, after signing informed consent, will receive TACE treatment. Envafolimab combined with Lenvatinib will be started on the day of TACE, and the subsequent TACE will be performed on demand. Patients will receive the treatment continuously until disease progression or intolerance. Tumor imaging evaluation will be performed according to RECIST V1.1 criteria every 6 weeks. Safety will be assessed with CTCAE 5.0. Adverse events throughout and within 30 days of the end of the study will be recorded (severe adverse events or adverse events associated with Envafolimab will be recorded within 90 days after the end of treatment).Treatment will last for 2 years or until disease progression, withdrawal of informed consent, loss of visit, or death.

Conditions

Interventions

DRUG

Envafolimab

300mg, subcutaneous injection, q3w

PROCEDURE

TACE

The first TACE will be started on d1, and the subsequent TACE will be performed on demand.

DRUG

Lenvatinib

8mg,QD (body weight \<60kg); 12mg, QD (body weight ≥ 60kg)

Sponsors & Collaborators

  • Zhejiang University

    lead OTHER

Principal Investigators

  • Tingbo Liang, PhD · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2022-09-01
Completion
2023-06-01

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 NCT05213221 on ClinicalTrials.gov