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A prospective, single-arm, phase II clinical study of Iodine 125 particle brachytherapy combined with TACE and lenvatinib and Tislelizumab for hepatocellular carcinoma with portal vein thrombosis

A prospective, single-arm, phase II clinical study of Iodine 125 particle brachytherapy combined with TACE and lenvatinib and Tislelizumab for hepatocellular carcinoma with portal vein thrombosis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106171
Enrollment
Unknown
Registered
2025-07-18
Start date
2025-03-13
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Hepatocellular carcinoma

Interventions

Experimental group:TACE + lenvatinib + Tislelizumab + iodine 125 particle implantation

Sponsors

First Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. age >18 years; 2. diagnosis of hepatocellular carcinoma (HCC); 3. stage BCLC-C; 4. portal vein thrombosis; 5. ECOG physical status score of 0 or 1; 6. Child-Pugh score of 5-8; 7. no previous treatment with immune checkpoint inhibitors or targeted drugs; 8. at least one intrahepatic measurable lesion

Exclusion criteria

Exclusion criteria: 1. combination of active infections, etc.; 2. with active autoimmune disease; 3. with hepatic encephalopathy, active gastrointestinal bleeding or uncontrollable ascites; 4. pregnant lactating mothers.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Progress-free survival;Overall survival;Safety;

Countries

China

Contacts

Public ContactYi Chen

First Hospital of Shanxi Medical University

chenyi5639@163.com+86 351 463 9773

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026