A Phase III Randomized Study of TACE Plus an Oral Triple-Agent Cocktail Versus TACE Plus First-Line Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apatinib, Camrelizumab, TACE, Thalidomide (drug).
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Randomized, Open-Label, Multicenter Phase III Trial Evaluating the Efficacy and Safety of Transarterial Chemoembolization Combined With an Oral Triple-Agent Cocktail Regimen Versus Transarterial Chemoembolization Combined With First-Line Targeted Therapy Plus Immunotherapy in Patients With Unresectable Hepatocellular Carcinoma
Overview
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).
Interventions
- Drug Apatinib
Apatinib: 250m, po, QD - Drug Camrelizumab
Camrelizumab: 200mg, iv, Q3W - Device TACE
TACE if necessary - Drug Thalidomide (drug)
Thalidomide：50-75mg, PO, qn; - Drug Capecitabine
Capecitabine: 500mg, PO, bid - Drug Compound cantharides capsule
Compound cantharides capsule: 750mg, PO, tid
Primary outcome measures
- Overall Survival (OS) [Time frame: Up to ~4 years]
Secondary outcome measures (5)
- Progression-Free Survival (PFS) [Time frame: Up to ~2 years]
- Time to Progression (TTP) [Time frame: Up to ~2 years]
- Objective Response Rate (ORR) [Time frame: Up to ~2 years]
- Duration of Response (DOR) [Time frame: Up to ~2 years]
- Health-Related Quality of Life (HRQoL) [Time frame: Up to ~2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07309419 · B2025-745R