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Clinical Trials List

Protocol NumberTRIO041
Active

2023-10-31 - 2027-08-31

Phase III

Not yet recruiting7

Recruiting1

ICD-10C22.0

Liver cell carcinoma

ICD-10C22.2

Hepatoblastoma

ICD-10C22.3

Angiosarcoma of liver

ICD-10C22.4

Other sarcomas of liver

ICD-10C22.7

Other specified carcinomas of liver

ICD-10C22.8

Malignant neoplasm of liver, primary, unspecified as to type

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9155.0

Malignant neoplasm of liver, primary

A Phase III, Multicenter, Randomized, Open-label Trial to Evaluate the Safety and Efficacy of Systemic Therapy With Regorafenib and Pembrolizumab Versus Locoregional Therapy With Transarterial Chemoembolization or Transarterial Radioembolization, for the First-line Treatment of Intermediate-stage Hepatocellular Carcinoma With Beyond Up-to-7 Criteria

  • Trial Applicant

    QPS

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator PEI-JER CHEN Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chang-Fang Chiu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shi-Ming Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TENG-YU LEE Digestive System Department
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Jing-Houng Wang Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ming-Chih Hou 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Carcinoma, Hepatocellular

Objectives

The usual treatment for patients with intermediate-stage liver cancer is TACE (transhepatic arterial chemoembolization) or TARE (transhepatic arterial radioembolization). In a TACE procedure, chemotherapy drugs are passed directly into the tumor through a catheter (a tube-shaped medical device placed in a blood vessel) through the blood vessels that supply the liver. The blood vessels are then blocked, allowing the drugs to stay in the liver longer. In the TARE procedure, small beads containing radioactive material are delivered to the tumor in the liver through a catheter in the blood vessels of the liver. However, not all patients with intermediate-stage liver cancer can benefit from this type of locoregional therapy, especially cases with large tumor burden. The overall purpose of this trial is to compare the efficacy and safety of these locoregional therapies (TACE/TARE) with a systemic therapy combination (regorafenib/pembrolizumab) in patients with intermediate-stage liver cancer to determine whether systemic therapy is more effective than TACE/TARE. .

Test Drug

Regorafenib
Keytruda injection/Keytruda

Active Ingredient

Regorafenib
Pembrolizumab

Dosage Form

tablet
injection

Dosage

30mg
100mg/4mL

Endpoints

Experimental: Regorafenib + Pembrolizumab
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.

Inclution Criteria

Inclusion Criteria:

Signed and dated Patient Informed Consent Form (PICF)
≥ 18 years-old at the time of PICF signature
Confirmed diagnosis of HCC
Intermediate-stage HCC, defined as follows:

Multinodular HCC localized to the liver
No evidence of MVI or EHS
Not amenable to curative treatment
Child-Pugh Class A
ECOG PS 0 or 1
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
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

Exclusion Criteria

Exclusion Criteria:

No measurable tumor of a diffuse infiltrative HCC type.
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.
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.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    496 participants

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