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Regorafenib Plus Tislelizumab as First-line Systemic Therapy for Patients With Advanced Hepatocellular Carcinoma

NCT04183088 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2020-12-23

No results posted yet for this study

Summary

Combination of anti-angiogenic molecular targeted therapy and anti- programmed cell death -1 immune checkpoint inhibitor (ICI) therapy has shown promising antitumor activity in multiple cancer types, including patients with advanced hepatocellular carcinoma (HCC). The safety profile and optimal dosage of targeted therapy should be carefully evaluated by clinical trials. Regorafenib is one of the standard second-line systemic therapy for advanced HCC. The present study will test the safety and efficacy of combination of regorafenib and tislelizumab, an anti-programmed cell death-1 ICI. The investigator(s) thus hypothesized that combination of tislelizumab and regorafenib is a tolerable regimen and may improve treatment efficacy for patients with advanced HCC. The present study will explore safety and efficacy of the combination of tislelizumab plus regorafenib as first-line therapy for advanced HCC.

Conditions

Interventions

DRUG

Tislelizumab+regorafenib for part 1;Tislelizumab+regorafenib for group 1 of part 2; Regorafenib for group 2 of part 2.

There will be no dose reduction for tislelizumab in this study. In the part 1(safety cohort), if the subjects do not experience grade 2 or greater regorafenib-related adverse events after 2 cycles (6 weeks) of treatment, the dosage of regorafenib may be escalated. For subjects who escalate the regorafenib dosage to Level 2, if the subjects do not experience grade 2 or greater regorafenib-related adverse events after 2 cycles of study drug treatment, the dosage of regorafenib may be further escalated to Level 3. During study drug treatment, dose delay/ interruption of regorafenib will be done depending on the occurrence and severity of regorafenib-related adverse events. After dose reduction of regorafenib, if the subjects tolerate the reduced dose of regorafenib well, the investigators may consider re-escalation of regorafenib to the previous dose level, depending on the types and severity of adverse events that led to dose reduction.

Sponsors & Collaborators

  • National Taiwan University Hospital, Yun-Lin Branch

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Ann-Lii Cheng, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2024-03-01
Completion
2025-03-01

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT04183088 on ClinicalTrials.gov