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Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma

NCT05389527 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-07-11

No results posted yet for this study

Summary

This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab as a neoadjuvant therapy in subjects with resectable hepatocellular carcinoma (HCC).

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Pembrolizumab+Lenvatinib

After enrollment, subjects receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for 9 weeks: Lenvatinib 8 mg (body weight \<60 kg) or 12 mg (body weight ≥60 kg) orally once daily for 9 weeks. Subjects conduct surgery 1 week after the last dose of Lenvatinib. 4 weeks after surgery, Pembrolizumab and Lenvatinib will restart as adjuvant treatment for up to 1 year.

Sponsors & Collaborators

Principal Investigators

  • Huichuan Sun · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-12-15
Completion
2025-07-31

Countries

  • China

Study Locations

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Entities

Companies

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 NCT05389527 on ClinicalTrials.gov