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Prospective, Multicenter, Randomized Controlled Study of Target-Immunotherapy Combined with Local Treatment for Hepatocellular Carcinoma with VP3/4 Portal Vein Tumor Thrombus

Prospective, Multicenter, Randomized Controlled Study of Target-Immunotherapy Combined with Local Treatment for Hepatocellular Carcinoma with VP3/4 Portal Vein Tumor Thrombus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124989
Enrollment
Unknown
Registered
2026-05-20
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma with VP3/4 Portal Vein Tumor Thrombus

Interventions

Trial group 1:Demand-based immune-enhanced TACE therapy (precise embolization via microcatheter superselective catheterization into tumor-feeding arteries targeting 1-3 lesions) combined with targeted
Trial group 2:Precise radiotherapy (4D-MRI combined with abdominal compression technique, hypofractionated regimen of 3Gy × 12-15 fractions) combined with targeted immunotherapy (camrelizumab 200mg Q3
Control group:Monotherapy with targeted immunotherapy (camrelizumab 200mg Q3W, apatinib mesylate tablets 250mg QD)

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically or radiologically confirmed HCC; 2. Grade VP3/4 portal vein tumor thrombus; 3. Child-Pugh score =12 weeks; 5. No prior systemic therapy for HCC, or an interval of >=1 month since last local treatment; 6. Age >=18 years, all genders.

Exclusion criteria

Exclusion criteria: 1. Presence of malignancies other than HCC; 2. Presence of severe cardiac, cerebral, renal, or pulmonary diseases or dysfunction; 3. History of gastrointestinal bleeding within 6 months prior to initiation; 4. Patients who have received or are scheduled for organ or bone marrow transplantation; 5. Patients currently on immunosuppressive agents or systemic corticosteroid therapy; 6. Patients with known hypersensitivity to the investigational drug or its excipients.

Design outcomes

Primary

MeasureTime frame
Overall Survival;

Secondary

MeasureTime frame
Serious Adverse Event;Disease Control Rate;Objective Response Rate;Progression-Free Survival;Adverse Event;

Countries

China

Contacts

Public ContactZhang Yonghong

Beijing Youan Hospital, Capital Medical University

13810108505@163.com+86 10 83997154

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026