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A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04712643
Collaborator
(none)
342
Enrollment
41
Locations
2
Arms
71.5
Anticipated Duration (Months)
8.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 12, 2021
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Feb 26, 2027

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • 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 Names:
  • Avastin

    • Device: Transarterial chemoembolization (TACE)
    TACE will be performed by clinical demand.
    Active Comparator: Arm B: TACE alone

    Participants will receive on-demand transarterial chemoembolization.

    Device: Transarterial chemoembolization (TACE)
    TACE will be performed by clinical demand.

    Outcome Measures

    Primary Outcome Measures

    1. TACE Progression-Free Survival (TACE PFS) as Determined by IRC [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).

    2. Overall Survival (OS) [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

    1. TACE PFS as Determined by Investigator [Randomization to untreatable progression or TACE failure/refractoriness or death (up to approximately 48 months)]

      TACE PFS as determined by the investigator.

    2. Time to Untreatable (unTACEable) Progression (TTUP) [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.

    3. Time to Progression (TTP) [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.

    4. Time to Macrovascular Invasion (MVI) [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.

    5. Time to Extrahepatic Spread (EHS) [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.

    6. Time to MVI/EHS [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.

    7. Objective Response Rate (ORR) [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.

    8. Duration of Responses (DOR) [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.

    9. Time to Deterioration (TTD) [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.

    10. Percentage of Participants With Adverse Events [Baseline up to apporximately 72 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University First Hospital Beijing City China 100034
    2 Beijing You An Hospital; Digestive Dept Beijing City China 100069
    3 Beijing Tsinghua Changgung Hospital Beijing City China 102218
    4 Peking University People's Hospital Beijing China 100044
    5 Hunan Cancer Hospital Changsha City China 410013
    6 Sichuan Cancer Hospital Chengdu City China 610041
    7 West China Hospital, Sichuan University; Surgical Oncology Chengdu City China 610041
    8 The First Affiliated Hospital, Chongqing Medical University Chongqing China 400016
    9 Southwest Hospital , Third Military Medical University Chongqing China 400038
    10 The First Affiliated Hospital Of Fujian Medical University Fuzhou City China 350005
    11 Mengchao Hepatobiliary Hospital Of Fujian Medical University Fuzhou City China 350025
    12 The 900th Hospital of PLA joint service support force Fuzhou China 110016
    13 Fujian Cancer Hospital Fuzhou China 350014
    14 Sun Yet-sen University Cancer Center Guangzhou China 510060
    15 Nanfang Hospital, Southern Medical University Guangzhou China 510515
    16 Harbin Medical University Cancer Hospital; internal medicine Harbin City China 150081
    17 Anhui Provincial Hospital Hefei China 230001
    18 Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) Nanjing City China 210029
    19 Jiangsu Cancer Hospital Nanjing City China 211100
    20 Guangxi Cancer Hospital of Guangxi Medical University Nanning China 530021
    21 The First Affiliate Hospital of Guangxi Medical University Nanning China 530021
    22 Zhongshan Hospital Fudan Unvierstiy Shanghai City China 200032
    23 Fudan University Shanghai Cancer Center Shanghai City China 200120
    24 Renji Hospital Shanghai Jiaotong University School of Medicine Shanghai City China 200127
    25 Shengjing Hospital of China Medical University ShenYang China 110004
    26 Tianjin Cancer Hospital; Surgical Department Tianjin City China 300060
    27 Hubei Cancer Hospital Wuhan China 430079
    28 The First Affiliated Hospital of Xi'an Jiaotong University; Hepatobiliary surgery Department Xi'an China 710049
    29 Zhejiang Cancer Hospital Zhejiang China 310022
    30 Henan Cancer Hospital Zhengzhou China 450008
    31 Zhuhai People's Hospital Zhuhai China 519099
    32 Aichi Cancer Center Aichi Japan 464-8681
    33 Chiba University Hospital Chiba Japan 260-8677
    34 Kurume University Hospital Fukuoka Japan 830-0011
    35 Hiroshima University Hospital Hiroshima Japan 734-8551
    36 Yokohama City University Medical Center Kanagawa Japan 232-0024
    37 Kanagawa Cancer Center Kanagawa Japan 241-8515
    38 Kitasato University Hospital Kanagawa Japan 252-0375
    39 Osaka University Hospital Osaka Japan 565-0871
    40 Kindai University Hospital Osaka Japan 589-8511
    41 Toranomon Hospital Tokyo Japan 105-8470

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04712643
    Other Study ID Numbers:
    • ML42612
    First Posted:
    Jan 15, 2021
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Hepatocellular
    Atezolizumab

    Study Results

    No Results Posted as of Aug 23, 2022