NCT07309419Not yet recruitingPhase 2/3
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 · Last updated 30 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 222 (estimated)
- First submitted
- 16 Dec 2025
- Start date
- 22 Dec 2025
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07309419
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 222
- From 22 Dec 2025 to the primary completion date, 30 Jun 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 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
Other illness
- Participants who have severe allergy to iodine, and unable to receive TACE
- Participants who had congenital or acquired immune deficiency, such as HIV infection
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.