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Checkpoint Inhibitor

Regorafenib + Pembrolizumab vs. Loco-Regional Therapy for Liver Cancer (REPLACE Trial)

Phase 3

Recruiting

Research Sponsored by Translational Research in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not amenable to curative treatment

Disease amenable to TACE or TARE and no contradiction to intra-arterial treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3.5 years

Awards & highlights

REPLACE Trial Summary

This trial evaluates a new treatment for people with liver cancer, comparing regorafenib and pembrolizumab to existing treatments. 496 patients will be studied worldwide.

Who is the study for?

This trial is for adults with confirmed intermediate-stage hepatocellular carcinoma (HCC) who haven't had prior systemic or loco-regional therapy. They should be in good physical condition, have liver cancer that's not curable by surgery, and can't have certain autoimmune diseases or recent major surgeries. Women must not be pregnant and participants must agree to use effective contraception.Check my eligibility

What is being tested?

The REPLACE trial compares Regorafenib with pembrolizumab (Rego-Pembro) against transarterial chemoembolization (TACE) or radioembolization (TARE). It aims to find out which treatment is better as a first-line option for liver cancer. Patients will continue treatments until disease progression or unacceptable side effects occur.See study design

What are the potential side effects?

Possible side effects include fatigue, diarrhea, high blood pressure from Regorafenib; immune-related reactions like skin issues, thyroid changes from pembrolizumab; and abdominal pain or fever post TACE/TARE procedures. Side effects vary based on the individual's reaction to the treatment.

REPLACE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition cannot be cured with treatment.

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My condition can be treated with TACE or TARE and I have no issues with treatments given through arteries.

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My liver cancer is confined to the liver and has multiple nodules.

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My liver functions well despite my illness.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have not had any treatment for liver cancer before.

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I have been diagnosed with liver cancer.

REPLACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS) Assessed by the Investigator as per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for HCC

Secondary outcome measures

Change from Baseline in Health-Related Quality of Life as Assessed by the EuroQol's 5-level EQ-5D Health Questionnaire (EQ-5D-5L)

Change from Baseline in Health-related Quality of Life in Hepatocellular Carcinoma as Assessed by European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire for HCC (EORTC QLQ-HCC18)

Change from Baseline in the Physical Functioning Sub-scale Score and Global Health Status/Quality of Life Scale Score as assessed by European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)

+7 more

REPLACE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Regorafenib + PembrolizumabExperimental Treatment1 Intervention

Investigational arm: regorafenib at a dose of 90 mg orally once per day (on days 1 to 21 of a 28-day cycle), in combination with pembrolizumab 400 mg using a 30-minute intravenous infusion, on day 1 of a 6-week cycle.

Group II: Loco-regional therapyActive Control1 Intervention

Control arm: Patients will be treated with TACE or TARE "on-demand" according to site's standard of practice.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor

2,240 Previous Clinical Trials

25,332,281 Total Patients Enrolled

17 Trials studying Hepatocellular Carcinoma

2,769 Patients Enrolled for Hepatocellular Carcinoma

Translational Research in OncologyLead Sponsor

21 Previous Clinical Trials

6,181 Total Patients Enrolled

1 Trials studying Hepatocellular Carcinoma

70 Patients Enrolled for Hepatocellular Carcinoma

Peter R Galle, MDStudy ChairUniversity Medical Center, Mainz, Germany

2 Previous Clinical Trials

195 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants currently involved in this experiment?

"Affirmative. Clinicaltrials.gov attests that this investigation is actively recruiting, having initially been posted on October 11th 2023 and modified most recently on the 12th of the same month. 496 participants are required from a single site for participation in this research endeavour."

Answered by AI

Has the FDA OK'd Regorafenib in conjunction with Pembrolizumab?

"Prior studies have generated data indicating Regorafenib + Pembrolizumab's efficacy and safety, thus our team rated the drug combination a 3 on the scale."

Answered by AI

Are there any remaining opportunities for patients to participate in this trial?

"Correct. According to the clinicaltrials.gov site, this investigation is in need of participants and was initially posted on October 11th 2023 with a last update occurring on December 10th 2023. In total, 496 patients are necessary from 1 medical centre for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7

2023. "Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04777851.

All > Hcc > Hepatocellular Carcinoma