NCT07157969RecruitingPhase 2
ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC
Immune Checkpoint Inhibitors and Anti-Vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without Interventional Therapy for Advanced HCC
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- 19 Feb 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07157969
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- From 19 Feb 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 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
- Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection.
Other illness
- Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation.
- Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
- History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
- Active autoimmune disease or history of autoimmune disorders.
- Significant history of gastrointestinal diseases.
- Significant history of cardiovascular or cerebrovascular diseases.
Other
- Pregnant or breastfeeding women.
- Presence of unhealed severe wounds, active ulcers, or untreated fractures.
Who the study is looking for
- Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
- Age ≥18 years at the time of signing informed consent, regardless of gender.
- Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
- BCLC Stage B or C.
- At least one measurable lesion per RECIST 1.1.
- ECOG score of 0-1.
- Child-Pugh liver function class A or B.
- Life expectancy ≥ 3 months.
- Adequate hematological and organ function.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.