A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT04712643
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome following TACE treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 342
- Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
- Eligible for TACE treatment
- No prior systemic therapy for HCC, especially immunotherapy
- No prior locoregional therapy to the target lesion(s)
- At least one measurable untreated lesion
- ECOG Performance Status of 0-1
- Child-Pugh class A
- Evidence of Vp3/4 and hepatic vein tumor thrombus (HVTT)
- Evidence of extrahepatic spread (EHS)
- Being a candidate for curative treatments
- Any condition representing a contraindication to TACE as determined by the investigators
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: atezolizumab + bevacizumab + TACE Becavizumab Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure. Arm A: atezolizumab + bevacizumab + TACE Transarterial chemoembolization (TACE) Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure. Arm B: TACE alone Transarterial chemoembolization (TACE) Participants will receive on-demand transarterial chemoembolization. Arm A: atezolizumab + bevacizumab + TACE Atezolizumab Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
- Primary Outcome Measures
Name Time Method TACE Progression-Free Survival (TACE PFS) as Determined by Investigator Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 46 months) TACE PFS is defined as the time from randomization to untreatable progression or TACE failure/refractoriness or any cause of death, whichever occurs first, as determined by the investigator (INV).
Overall Survival (OS) Randomization to death from any cause (up to approximately 94 months) Overall survival (OS) after enrollment is defined as the time from randomization to death from any cause.
- Secondary Outcome Measures
Name Time Method Time to Untreatable (unTACEable) Progression (TTUP) as Determined by Investigator Randomization to untreatable (unTACEable) progression (up to approximately 46 months) INV-assessed TTUP is defined as time from randomization to untreatable (unTACEable) progression, as determined by investigator.
Time to Progression (TTP) as Determined by Investigator Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 46 months) INV-assessed TTP is defined as the time from randomization to unTACEable progression or TACE failure/refractoriness (as defined above), as determined by investigator.
Time to Extrahepatic Spread (EHS) as Determined by Investigator Randomization to first evidence of EHS (up to approximately 46 months) INV-assessed time to EHS is defined as the time from randomization to the first evidence of EHS, as determined by investigator.
Objective Response Rate (ORR), as Determined by Investigator Randomization up to approximately 46 months Objective response (OR) is defined as a complete or partial response, as determined by investigator.
Duration of Responses (DOR) as Determined by Investigator First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 46 months) INV-assessed DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by INV.
Progression Free Survival (PFS) Randomization to first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 94 monthsJ) Progression free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time to Deterioration (TTD) Randomization to first deterioration (up to approximately 94 months) TTD is defined as the time from randomization to first deterioration in the patient-reported GHS/QoL, physical function, or role function scales of the EORTC QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
Percentage of Participants With Adverse Events Baseline up to approximately 94 months
Trial Locations
- Locations (40)
Anhui Provincial Hospital
🇨🇳Anhui, China
Peking University First Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Beijing You An Hospital
🇨🇳Beijing, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, China
Hunan Cancer Hospital
🇨🇳Changsha, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
The First Affiliated Hospital, Chongqing Medical University
🇨🇳Chongqing, China
Southwest Hospital , Third Military Medical University
🇨🇳Chongqing, China
The 900th Hospital of PLA joint service support force
🇨🇳Fuzhou, China
Scroll for more (30 remaining)Anhui Provincial Hospital🇨🇳Anhui, China