Atezolizumab/Bevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab/Bevacizumab (DEMAND)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    106
  • sponsor
    Ludwig-Maximilians - University of Munich
Updated on 4 March 2022
TACE
chemoembolization

Summary

Aim of the study is to evaluate the efficacy of up-front atezolizumab/ bevacizumab (Atezo/Bev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo/Bev in the treatment of unresectable HCC patients.

Details
Condition Hepatocellular Carcinoma Non-resectable
Treatment Atezolizumab Injection, Bevacizumab Injection
Clinical Study IdentifierNCT04224636
SponsorLudwig-Maximilians - University of Munich
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient's signed informed consent
Age 18 years at time of signing Informed Consent Form
Ability to comply with the study protocol, according to investigator's judgement
Life expectancy of at least 12 weeks
HCC with histologically confirmed diagnosis
Disease that is not amenable to curative surgical and/or local ablation but eligible for TACE
ECOG Performance Status of 0 or 1
Child-Pugh class A or B7
Adequate hematologic and end-organ function
Negative HIV test at screening

Exclusion Criteria

Diffuse HCC or presence of vascular invasion or extrahepatic spread or more than 7 lesions or at least one lesion >= 7 cm
Clinically relevant ascites
Uncontrolled pleural effusion or pericardial effusion
History or presence of hepatic encephalopathy
Co-infection of HBV and HCV
Patients on a liver transplantation list
Prior systemic therapy for HCC
Prior treatment with TACE or selective internal radiation treatment (SIRT)
Any condition representing a contraindication to TACE
Major gastrointestinal bleeding within 4 weeks prior to randomization, untreated or incompletely treated varices with bleeding or high-risk for bleeding
Active or history of autoimmune disease or immune deficiency
Prior allogeneic stem cell or solid organ transplantation
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Active tuberculosis
Severe infection requiring antibiotics within 4 weeks prior to randomization
Significant cardiovascular disease
History of congenital long QT syndrome or corrected QT interval >500 ms at screening ECG
Inadequately controlled arterial hypertension or prior history of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease including aortic aneurysm requiring surgical repair or peripheral arterial thrombosis with 6 months prior to randomization
History of abdominal or tracheoesophageal fistula or gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization
History or clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding. Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure
History of intra-abdominal inflammatory process within 6 months prior to randomization, including but not limited to peptic ulcer disease, diverticulitis, or colitis
Evidence of bleeding diathesis or significant coagulopathy
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at enrollment
Severe, non healing or dehisced wound, active ulcer, or untreated bone fracture
History of malignancy other than HCC, with the exception of patients who have been disease-free for at least five years before enrollment or patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer
Current or recent (within 10 days of randomization) use of acetylsalicyclic acid or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol
Current or recent (within 10 days prior to randomization) use of full dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose
Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID). Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed
Treatment with a live, attenuated vaccine within 4 weeks prior to randomization, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and antiPD-L1 therapeutic antibodies
Hypersensitivity to atezolizumab or bevacizumab or any of the excipients, known hypersensitivity to Chinese hamster ovary cell products, known hypersensitivity to human or humanized antibodies
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to randomization
Treatment with systemic immunosuppressive medication within 2 weeks prior to randomization, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions
Patients who received acute, low-dose systemic immunosuppressant medication or
a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours
of corticosteroids for a contrast allergy) are eligible
Inhaled corticosteroids for chronic obstructive pulmonary disease or bronchial
asthma, supplemental mineralocorticosteroids or low-dose corticosteroids for
adrenalcortical insufficiency are allowed
\. Major surgical procedure other than for diagnosis, open biopsy, or
significant traumatic injury within 28 days prior to randomization, or
abdominal surgery, abdominal interventions or significant abdominal traumatic
injury within 60 days prior to randomization or anticipation of need for major
surgical procedure during the course of the study or non-recovery from side
effects of any such procedure
\. Core biopsy or other minor surgical procedure, excluding placement of a
vascular access device, within 3 days prior to the first dose of bevacizumab
\. Pregnant or breastfeeding females
\. Participation in a clinical trial or experimental drug treatment within
days prior to inclusion in the clinical trial or within a period of 5 half-
lives of the substances administered in a clinical trial or during an
experimental drug treatment prior to inclusion in the clinical trial
depending on which period is longest, or simultaneous participation in another
clinical trial while taking part in this clinical trial
\. Patient committed to an institution by virtue of an order issued either
by the judicial or the administrative authorities
\. Patient possibly dependent from the investigator including the spouse
children and close relatives of any investigator
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