Clinical trial · Interventional
A Phase III Randomized Study of TACE Plus an Oral Triple-Agent Cocktail Versus TACE Plus First-Line Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Compound cantharides capsule | Drug | — | UNRESOLVED |
| TACE | Device | — | UNRESOLVED |
| Thalidomide (drug) | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: apatinib + camrelizumab + TACE
- description
- Participants will receive apatinib plus camrelizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
- interventionNames
- Drug: Apatinib
- Drug: Camrelizumab
- Device: TACE
- type
- EXPERIMENTAL
- label
- Arm B: Thalidomide + Capecitabine + Compound cantharides capsule + TACE
- 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.
- interventionNames
- Device: TACE
- Drug: Thalidomide (drug)
- Drug: Capecitabine
- Drug: Compound cantharides capsule
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available