Combining TACE with immune therapy and stent placement for liver cancer patients with portal vein blockage
Transcatheter Arterial Chemoembolization Combined With ICIs Plus MTT After Irradiation Stent Placement in HCC With Main PVTT: a Multicenter Propensity Score Matching Study
This study is testing a new treatment for liver cancer patients with blocked blood vessels to see if combining different therapies can help them live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 444 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhongda Hospital Academic / other |
| Drugs / interventions | radiation, atezolizumab, bevacizumab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06669377 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of combining transcatheter arterial chemoembolization (TACE) with immune checkpoint inhibitors (ICIs) and molecular targeted therapy (MTT) after placing an irradiation stent in patients with hepatocellular carcinoma (HCC) and main portal vein tumor thrombosis (PVTT). Given the poor prognosis associated with HCC and PVTT, the study aims to explore a novel treatment approach that may improve overall survival and progression-free survival. Patients will be monitored for treatment outcomes and safety over a specified period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed HCC and main portal vein tumor thrombosis.
Not a fit: Patients with extrahepatic metastases or concurrent malignancies are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with advanced liver cancer and portal vein blockage.
How similar studies have performed: While some studies have explored TACE in similar contexts, this specific combination approach remains novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age ≥18 years old; (2) diagnosis of HCC is confirmed through histological or cytological analysis, as well as clinical features; (3) histologically confirmed or imaging-diagnosed PVTT extending to the main portal vein (Vp4); (4) including at least one measurable intrahepatic lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; (5) Eastern Cooperative Oncology Group (ECOG) performance status of ≤2; (6) patients received first-line treatment with either ICIs-MTT or an ISP-containing quadruple combination within eight weeks (In the ICIs-MTT group, MTT was administered alongside ICIs. In the ISP-containing quadruple, TIT and ICIs-MTT were given after stent placement and portal vein recanalization, either simultaneously or within eight weeks before or after the ICIs-MTT therapy). Exclusion Criteria: 1. patients with extrahepatic metastases; (2) a history of or concurrent malignancies; (3) patients underwent prior systemic treatments or locoregional therapies, including surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection, and cryoablation, within three months before the initiation of ISP.; (4) Child-Pugh grade C liver function, a Child-Pugh score of 3 for ascites, or the presence of overt hepatic encephalopathy; (5) incomplete outcome data or missing essential baseline factors for analysis.
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Gaojun Teng, M.D. — Zhongda Hospital
- Study coordinator: Jian Lu, M.D.
- Email: lujian43307131@126.com
- Phone: +86-15850654644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.