TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
Recruiting now · Not applicable
Conditions studied: Hepatocellular Carcinoma, Hepatic Portal Vein Tumor Invasion, Tumor Thrombus
In brief
The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab/Bevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I/II PVTT (Based on Cheng's PVTT classification).
Key facts
- Study ID
- NCT05984511
- Run by
- Third Affiliated Hospital, Sun Yat-Sen University
- People needed
- 234
- Starts
- 2023-08-30
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2025-02-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- The Third Affiliated Hospital of Sun Yat-Sen University — Guangzhou, Guangzhou, China (enrolling)
Full record on ClinicalTrials.gov
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