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New treatment option for Hepatocellular Carcinoma
Official title TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
ClinicalTrials.gov ID: NCT05984511
What this study is testing
What is Atezolizumab plus Bevacizumab?
Atezolizumab plus Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as atezolizumab-bevacizumab; Atez/Bev treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join if
- Diffuse HCC;
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by...
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.