A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
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| ClinicalTrials.gov Identifier: NCT04712643 |
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Recruitment Status :
Recruiting
First Posted : January 15, 2021
Last Update Posted : February 15, 2022
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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 unsuitable for curative therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma | Drug: Atezolizumab Drug: Becavizumab Device: Transarterial chemoembolization (TACE) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 342 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Open-Label, Randomized Study of On-Demand TACE Combined With Atezolizumab Plus Bevacizumab (Atezo/Bev) or On-Demand TACE Alone in Patients With Untreated Heaptocellular Carcionma |
| Actual Study Start Date : | March 12, 2021 |
| Estimated Primary Completion Date : | February 28, 2025 |
| Estimated Study Completion Date : | February 26, 2027 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: atezolizumab + bevacizumab + TACE
Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
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Drug: Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until participant experience loss of clinical benefit as evaluated by the investigator or unacceptable toxicity or withdrawal of informed consent.
Other Name: Tecentriq Drug: Becavizumab Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
Other Name: Avastin Device: Transarterial chemoembolization (TACE) TACE will be performed by clinical demand. |
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Active Comparator: Arm B: TACE alone
Participants will receive on-demand transarterial chemoembolization.
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Device: Transarterial chemoembolization (TACE)
TACE will be performed by clinical demand. |
Primary Outcome Measures :
- TACE Progression-Free Survival (TACE PFS) as Determined by IRC [ Time Frame: Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 48 months) ]TACE PFS is defined as the time from randomization to untreatable progression or TACE failure/refractoriness and any cause of death, as determined by the independent review committee (IRC).
- Overall Survival (OS) [ Time Frame: Randomization to death from any cause (up to approximately 72 months) ]Overall survival (OS) after enrollment is defined as the time from randomization to death from any cause.
Secondary Outcome Measures :
- TACE PFS as Determined by Investigator [ Time Frame: Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 48 months) ]TACE PFS as determined by the investigator.
- Time to Untreatable (unTACEable) Progression (TTUP) [ Time Frame: Randomization to Child-Pugh B8 or worse, intrahepatic tumor progression, with new lesions NOT defined as tumor progression, MVI or EHS (up to approximately 48 months) ]Time to untreatable (unTACEable) progression (TTUP) is defined as time from randomization to Child-Pugh B8 or worse, intrahepatic tumor progression, with new lesions NOT defined as tumor progression, MVI or EHS, as determined by the IRC and investigator.
- Time to Progression (TTP) [ Time Frame: Randomization to unTACEable progression or TACE failure/refractoriness (up to approximately 48 months) ]Time to progression (TTP) is defined as the time from randomization to unTACEable progression or TACE failure/refractoriness, as determined by the IRC and investigator.
- Time to Macrovascular Invasion (MVI) [ Time Frame: Ranodimzation to first evidence of MVI (up to approximately 48 months ) ]Time to MVI is defined as the time from randomization to the first evidence of MVI, as determined by the IRC and investigator.
- Time to Extrahepatic Spread (EHS) [ Time Frame: Randomization to first evidence of EHS (up to approximately 48 months) ]Time to EHS is defined as the time from randomization to the first evidence of EHS, as determined by the IRC and investigator.
- Time to MVI/EHS [ Time Frame: Randomization to first evidence of MVI/EHS (up to approximately 48 months) ]Time to MVI/EHS is defined as the time from randomization to the first evidence of MVI/EHS (whichever occurs first), as determined by the IRC and investigator.
- Objective Response Rate (ORR) [ Time Frame: Randomization up to approximately 72 months ]Objective response rate (ORR) is defined as the percentage of participants who have a complete or partial response, as determined by the IRC and investigator.
- Duration of Responses (DOR) [ Time Frame: First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 72 months) ]Duration of responses (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 the IRC and investigator.
- Time to Deterioration (TTD) [ Time Frame: Randomization to first deterioration (up to approximately 72 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.
- Percentage of Participants With Adverse Events [ Time Frame: Baseline up to apporximately 72 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Evidence of macrovascular invasion (MVI)
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712643
Contacts
| Contact: Reference Study ID Number: ML42612 https://forpatients.roche.com/ | 888-662-6728 (U.S. and Canada) | global.rochegenentechtrials@roche.com |
Locations
Show 33 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT04712643 |
| Other Study ID Numbers: |
ML42612 |
| First Posted: | January 15, 2021 Key Record Dates |
| Last Update Posted: | February 15, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Liver Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Atezolizumab Antineoplastic Agents |