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

NCT ID: NCT07309419

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-22

Study Completion Date

2030-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm A: apatinib + camrelizumab + TACE

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

Group Type ACTIVE_COMPARATOR

Apatinib

Intervention Type DRUG

Apatinib: 250m, po, QD

Camrelizumab

Intervention Type DRUG

Camrelizumab: 200mg, iv, Q3W

TACE

Intervention Type DEVICE

TACE if necessary

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

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.

Group Type EXPERIMENTAL

TACE

Intervention Type DEVICE

TACE if necessary

Thalidomide (drug)

Intervention Type DRUG

Thalidomide：50-75mg, PO, qn;

Capecitabine

Intervention Type DRUG

Capecitabine: 500mg, PO, bid

Compound cantharides capsule

Intervention Type DRUG

Compound cantharides capsule: 750mg, PO, tid

Interventions

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Apatinib

Apatinib: 250m, po, QD

Intervention Type DRUG

Camrelizumab

Camrelizumab: 200mg, iv, Q3W

Intervention Type DRUG

TACE

TACE if necessary

Intervention Type DEVICE

Thalidomide (drug)

Thalidomide：50-75mg, PO, qn;

Intervention Type DRUG

Capecitabine

Capecitabine: 500mg, PO, bid

Intervention Type DRUG

Compound cantharides capsule

Compound cantharides capsule: 750mg, PO, tid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jinglin Xia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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B2025-745R

Identifier Type: -

Identifier Source: org_study_id