A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

Conditions

• Hepatocellular Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab will be administered at a dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.
• Bevacizumab — DRUG
  Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) by IV infusion on Day 1 of each 21-day cycle.

Study Details

The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-pugh B7 or B8 cirrhosis.

Key Dates

Start date

Jul 15, 2024

Status verified

May 2026

Primary completion

Jul 30, 2027

Completion

Dec 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: Atezolizumab+Bevacizumab
  Participants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator.
• Experimental: Cohort B: Atezolizumab
  Participants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline through the end of the study (up to approximately 36 months) ]

Central Contacts

• Reference Study ID Number: ML44719 https://forpatients.roche.com/
  888-662-6728 (U.S. and Canada)
  [email protected]

Locations (60)

Find similar trials in Tucson, AZ

Related Studies

• Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
  PHASE1/PHASE2 · Recruiting · Teclison Ltd. · Palo Alto, California
• Combination of TATE and PD-1 Inhibitor in Liver Cancer
  PHASE2 · Recruiting · Teclison Ltd. · Orange, California
• Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
  PHASE1/PHASE2 · Recruiting · Anwaar Saeed · Westwood, Kansas
• Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
  Recruiting · University of Tennessee · Knoxville, Tennessee