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Check eligibility

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Key inclusion criteria

  

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

Key exclusion criteria

   

  1. Diffuse HCC or presence of vascular invasion      or extrahepatic spread or more than 7 lesions or at least one lesion >=      7 cm
  2. Clinically relevant ascites, history or      presence of hepatic encephalopathy
  3. Uncontrolled pleural effusion or pericardial      effusion
  4. Co-infection of HBV and HCV
  5. Prior systemic therapy for HCC, prior treatment      with TACE or selective internal radiation treatment (SIRT)
  6. Any condition representing a contraindication      to TACE
  7. Major gastrointestinal bleeding within 4 weeks      prior to randomization, untreated or incompletely treated varices with      bleeding or high-risk for bleeding.
  8. Active or history of autoimmune disease or      immune deficiency, patients actively listed for transplantation, or prior      allogeneic stem cell or solid organ transplantation
  9. 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
  10. Active tuberculosis
  11. Severe infection requiring antibiotics within      4 weeks prior to randomization
  12. Significant cardiovascular disease
  13. History of congenital long QT syndrome or      corrected QT interval >500 ms at screening ECG
  14. Inadequately controlled arterial hypertension      or prior history of hypertensive crisis or hypertensive encephalopathy
  15. Significant vascular disease including aortic      aneurysm requiring surgical repair or peripheral arterial thrombosis with      6 months prior to randomization
  16. History of abdominal or tracheoesophageal      fistula or gastrointestinal perforation, or intra-abdominal abscess within      6 months prior to randomization.
  17. 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
  18. History of intra-abdominal inflammatory      process within 6 months prior to randomization, including but not limited      to peptic ulcer disease, diverticulitis, or colitis
  19. Evidence of bleeding diathesis or significant      coagulopathy
  20. 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.
  21. Uncontrolled tumor-related pain. Patients      requiring pain medication must be on a stable regimen at enrollment.
  22. Severe, non healing or dehisced wound, active      ulcer, or untreated bone fracture
  23. 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
  24. Current or recent (within 10 days of      randomization) use of acetylsalicyclic acid or treatment with      dipyramidole, ticlopidine, clopidogrel, and cilostazol
  25. Current or recent (within 10 days prior to      randomization) use of full dose oral or parenteral anticoagulants or      thrombolytic agents for therapeutic purpose.
  26. 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.
  27. 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
  28. Prior treatment with CD137 agonists or immune      checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and      antiPD-L1 therapeutic antibodies
  29. 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
  30. 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
  31. 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:
  32. 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
  33. Core biopsy or other minor surgical procedure,      excluding placement of a vascular access device, within 3 days prior to      the first dose of bevacizumab
  34. Pregnant or breastfeeding females
  35. Participation in a clinical trial or      experimental drug treatment within 28 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.

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