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Regorafenib-pembrolizumab vs. TACE/TARE in intermediate-stage HCC beyond up-to-7.
EU CTIS ID: 2022-501969-42-00
What this study is testing
Compare PFS for Rego-Pembro versus TACE/TARE in patients with intermediate-stage HCC, based on Investigator´s assessment (using mRECIST for HCC).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated Patient Informed Consent Form (PICF).
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.
- Women of childbearing potential (CBP) must have confirmed negative serum pregnancy test.
- Use of highly-effective contraceptive methods in women of CBP and men.
- Patients with hepatitis C virus (HCV) or hepatitis B virus (HBV) infection are eligible if they meet criteria as defined within the protocol.
- ≥ 18 years-old at the time of PICF signature.
You likely can't join if
- No measurable tumor of a diffuse infiltrative HCC type.
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed ≤ 2 years before randomization.
- Persistent proteinuria of NCI-CTCAE v5.0 Grade 3.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
- Fibrolamellar HCC, sarcomatoid HCC or mixed hepatocellular/ cholangiocarcinoma subtypes.
- Clinically meaningful ascites.
See the full eligibility criteria
- Signed and dated Patient Informed Consent Form (PICF).
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.
- Women of childbearing potential (CBP) must have confirmed negative serum pregnancy test.
- Use of highly-effective contraceptive methods in women of CBP and men.
- Patients with hepatitis C virus (HCV) or hepatitis B virus (HBV) infection are eligible if they meet criteria as defined within the protocol.
- ≥ 18 years-old at the time of PICF signature.
- Confirmed diagnosis of HCC.
- Intermediate-stage HCC, defined as follows: 1. Multinodular HCC localized to the liver, 2. No evidence of MVI or EHS, 3. Not amenable to curative treatment, 4. Child-Pugh Class A, 5. ECOG PS 0 or 1, 6. ALBI grade 1 or 2.
- Beyond up-to-seven criteria.
- Disease amenable to TACE or TARE and no contradiction to intra-arterial treatment.
- Measurable disease by CT or MRI as per RECIST 1.1.
- No prior systemic therapy or loco-regional therapy for HCC.
- Adequate hematologic and organ function.
- No measurable tumor of a diffuse infiltrative HCC type.
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed ≤ 2 years before randomization.
- Persistent proteinuria of NCI-CTCAE v5.0 Grade 3.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
- Fibrolamellar HCC, sarcomatoid HCC or mixed hepatocellular/ cholangiocarcinoma subtypes.
- Clinically meaningful ascites.
- Prior treatment with regorafenib, a PD-1, PD-L1/PD-L2, or cytotoxic T lymphocyte associated protein 4 (CTLA-4) inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to randomization.
- Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids.
- Requirement of systemic treatment with either corticosteroids or other immunosuppressive medications ≤ 14 days prior to randomization.
- Interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, or clinically significant acute lung diseases.
- Cardiovascular conditions as defined within the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Korea, Republic of
- Turkey
- United States
- Georgia
- Serbia
- Taiwan
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; Korea, Republic of; Turkey; United States; Georgia; Serbia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.