Combination treatment for advanced liver cancer with portal vein tumor invasion
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial
This study is testing a new combination treatment for advanced liver cancer with portal vein tumor invasion to see if it helps patients live longer compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | Atezolizumab, Bevacizumab |
| Locations | 1 site (Guangzhou, Guangzhou) |
| Trial ID | NCT05984511 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination therapy involving Atezolizumab, Bevacizumab, transcatheter arterial chemoembolization (TACE), and I-125 Seeds Brachytherapy in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). It is a multicenter, open-label, randomized controlled trial that aims to compare the new treatment regimen (TACE-AB-I) against a standard treatment (TACE-AB). A total of 234 patients will be enrolled, and the study will assess survival outcomes and safety profiles of the two treatment approaches. Patients will receive TACE followed by the immunotherapy and brachytherapy as per the assigned group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of hepatocellular carcinoma and Type I or II portal vein tumor thrombosis.
Not a fit: Patients with diffuse HCC, extrahepatic spread, or certain other liver cancer subtypes will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced liver cancer and portal vein tumor invasion.
How similar studies have performed: Other studies have shown promising results with similar combination therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between18 and 75 years; * Has a diagnosis of HCC confirmed by radiology, histology, or cytology; * Type I PVTT or type II PVTT; * Child-Pugh class A; * Eastern Cooperative Group performance status (ECOG) score of 0-1; * No prior systemic therapy for HCC. * Adequate hematologic and end-organ function; * At least one measurable intrahepatic target lesion. Exclusion Criteria: * Diffuse HCC; * Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible; * Evidence of extrahepatic spread (EHS); * Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators; * Evidence or history of bleeding diathesis or any hemorrhage or bleeding event \>CTCAE grade 3 within 4 weeks prior to randomization; * Active or history of autoimmune disease or immune deficiency; * Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding; * A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment; * Evidence of bleeding diathesis or significant coagulopathy; * Pregnant or breastfeeding females; * Significant cardiovascular disease; * Severe infection, such as active tuberculosis; * Serious medical comorbidities; * History of organ or cells transplantation; * History of other uncurable malignancies.
Where this trial is running
Guangzhou, Guangzhou
- The Third Affiliated Hospital of Sun Yat-Sen University — Guangzhou, Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Mingsheng Huang, M.D. & Ph.D. — Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University
- Study coordinator: Mingsheng Huang, M.D. & Ph.D.
- Email: huangmsh@mail.sysu.edu.cn
- Phone: +86-02085253416
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.