MedTrace Logo

Efficacy and Safety Comparison Between Intensified Therapy and Conversion Therapy For Advanced HCC After Failure of First-line

NCT07501351 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-30

No results posted yet for this study

Summary

Although immunotherapy-based therapies (including targeted-immunotherapy or dual-immunotherapy protocols) have become the first-line standard treatment for advanced hepatocellular carcinoma (HCC), there remains a lack of high-level evidence to guide the selection of second-line therapies following progression in immune checkpoint inhibitors (ICIs). Additionally, direct comparative data are scarce for combination treatment modalities such as "continuation of the original first-line regimen with added agents" or "switching to agents with different mechanisms".

To address this clinical need and explore novel second-line treatment strategies for advanced HCC, we plan to conduct an exploratory clinical trial to investigate the efficacy and safety comparison between intensified therapy (plus lenvatinib) and conversion therapy (regorafenib combined with PD-1 inhibitor) for advanced hepatocellular carcinoma after failure of fFirst-line bevacizumab plus sintilimab.

Conditions

  • Hepatocellulcar Carcinoma

Interventions

DRUG

Intensified Therapy

Bevacizumab, 15mg/kg, iv drip, q3w; Sintilimab, 200mg/dose, iv drip, q3w; Lenvatinib, for weight ≤60 kg, 8 mg/d, po, qd; for weight \>60 kg, 12 mg/d, po, qd.

DRUG

Conversion Therapy

Regorafenib, 160mg/d, po, qd; PD-1 inhibitor (Sintilimab, Camrelizumab, Tislelizumab, Toripalimab, Pembrolizumab), 200mg/dose, iv drip, q3w.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2026-10-31
Completion
2026-12-31

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 NCT07501351 on ClinicalTrials.gov