NCT05213221

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

Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients: an Open, Single Arm, Phase II Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-03-14
• Primary completion: 2022-09-01
• Completion: 2023-06-01
• First posted: 2022-01-28
• Last updated: 2023-06-13

Locations

1 site across 1 country: China