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

NCT07309419 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: B2025-745R
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival is defined as the time from randomization to death from any cause. OS will be assessed in the intention-to-treat (ITT) population, which includes all randomized participants.

  Up to ~4 years

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Up to ~2 years

• Time to Progression (TTP)

  Up to ~2 years

• Objective Response Rate (ORR)

  Up to ~2 years

• Duration of Response (DOR)

  Up to ~2 years

• Health-Related Quality of Life (HRQoL)

  Up to ~2 years

Study Arms (2)

Arm A: apatinib + camrelizumab + TACE

ACTIVE COMPARATOR

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

Drug: Apatinib; Drug: Camrelizumab; Device: TACE

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

EXPERIMENTAL

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.

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

Interventions

Apatinib DRUG

Apatinib: 250m, po, QD

Arm A: apatinib + camrelizumab + TACE

Camrelizumab DRUG

Camrelizumab: 200mg, iv, Q3W

Arm A: apatinib + camrelizumab + TACE

TACE DEVICE

TACE if necessary

Arm A: apatinib + camrelizumab + TACE; Arm B: Thalidomide + Capecitabine + Compound cantharides capsule + TACE

Thalidomide (drug) DRUG

Thalidomide：50-75mg, PO, qn;

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

Capecitabine DRUG

Capecitabine: 500mg, PO, bid

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

Compound cantharides capsule DRUG

Compound cantharides capsule: 750mg, PO, tid

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

apatinib; camrelizumab; Thalidomide; Pharmaceutical Preparations; Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share