A Phase III Randomized Study of TACE Plus an Oral Triple-Agent Cocktail Versus TACE Plus First-Line Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma (Cocktail-001)

Fudan University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Capecitabine; Drug: Apatinib; Drug: Compound cantharides capsule; Drug: Thalidomide (drug); Drug: Camrelizumab; Device: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT07309419

B2025-745R

Details and patient eligibility

About

This is a prospective, multicenter, randomized, open-label phase 3 study evaluating the efficacy and safety of transarterial chemoembolization (TACE) combined with a triple oral cocktail regimen versus TACE combined with targeted therapy plus immunotherapy as first-line treatment for unresectable hepatocellular carcinoma (HCC).

Enrollment: 222 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years at the time of enrollment.
• Diagnosis of hepatocellular carcinoma (HCC) established according to the Chinese National Liver Cancer (CNLC) guidelines, based on imaging findings and/or histopathological confirmation.
• Not eligible for curative treatment, including surgical resection, local ablation, or liver transplantation.
• No prior treatment for HCC, including any locoregional or systemic anticancer therapies.
• Child-Pugh liver function class A or B 7.

Exclusion criteria

• Participants who had another previous or current malignant tumor, except for early-stage cancer with low risk of recurrence or a malignant tumor curatively treated >5 years prior to enrolment with no recurrence
• Participants who have severe allergy to iodine, and unable to receive TACE
• Participants who have undergone a liver transplant or allogeneic bone marrow transplantation, or those who are in the waiting list for liver or bone marrow transplantation
• Participants who had congenital or acquired immune deficiency, such as HIV infection
• Participants who had a history of gastrointestinal bleeding within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding
• Participants who had undergone arterial thromboembolism within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding, such as cerebrovascular accident, ≥ CTCAE grade 3 deep vein thrombosis and pulmonary embolism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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222 participants in 2 patient groups

Arm A: apatinib + camrelizumab + TACE

Active Comparator group

Description:

Participants will receive apatinib plus camrelizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.

Treatment:

Device: TACE

Drug: Camrelizumab

Drug: Apatinib

Arm B: Thalidomide + Capecitabine + Compound cantharides capsule + TACE

Experimental group

Description:

Participants assigned to this arm will receive an oral triple-agent regimen consisting of thalidomide, capecitabine, and compound cantharides capsules. The oral regimen will be initiated immediately after the initial transarterial chemoembolization (TACE) procedure and administered continuously thereafter.

Treatment:

Device: TACE

Drug: Compound cantharides capsule

Drug: Thalidomide (drug)

Drug: Capecitabine