Recruiting

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

# NCT04102098 Trial phase: 3 Study type: immunotherapy, targeted

Study Start Date

December, 2019

Scientific Title

A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Summary

This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.

- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

- Recurrent HCC prior to randomization

- Evidence of residual, recurrent, or metastatic disease at randomization

- Clinically significant ascites

- History of hepatic encephalopathy

- Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization

- Have received more than 1 cycle of adjuvant TACE following surgical resection

- Active or history of autoimmune disease or immune deficiency

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan

- Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1, unstable arrhythmia, or unstable angina

- History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

- Active tuberculosis

- 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

- Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to Day 1 of Cycle 1.

- Co-infection with HBV and HCV.

- Uncontrolled or symptomatic hypercalcemia

- Any treatment for HCC prior to resection or ablation, including systemic therapy and locoregional therapy such as TACE

- Treatment with systemic immunostimulatory or immunosuppressive agents

- Inadequately controlled arterial hypertension

- History of hypertensive crisis or hypertensive encephalopathy

- Significant vascular disease

- Evidence of bleeding diathesis or significant coagulopathy

- Current or recent use of aspirin or full-dose oral or parenteral anticoagulants

- Core biopsy within 3 days of Day 1 of Cycle 1

- History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess

- Serious non-healing or dehiscing wound

- Major surgical procedure within four weeks

- Chronic daily treatment with a non-steroidal anti-inflammatory drug

Study Design

Primary purpose: Treatment , Allocation: Randomized , Intervention model: Parallel Assignment , Masking: None (Open Label)

Conditions

Carcinoma, Hepatocellular

Locations

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