A Clinical trial/study Of Atezolizumab With Lenvatinib Or Sorafenib Versus Lenvatinib Or Sorafenib Alone In patients with Hepatocellular Carcinoma.
Phase 3
Active, not recruiting
- Conditions
- Liver cell carcinoma,
- Registration Number
- CTRI/2024/01/061668
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in patients with locally advanced or metastatic HCC who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination. Prior to each site initiation, either lenvatinib or sorafenib will be selected for study treatment by the investigator for all patients from the respective site.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 554
Inclusion Criteria
- Locally advanced or metastatic and or unresectable HCC with diagnosis confirmed by histology or cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients.
- Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments.
- It is required that at least 1 tumor assessment shows either stable disease, partial response, or complete response.
- Child-Pugh class A within 7 days prior to randomization.
- ECOG Performance Status of 0 or 1 within 7 days prior to randomization.
- Life expectancy of at least 12 weeks.
- Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade less than equal to 1 prior to study entry, with the exception of alopecia.
Exclusion Criteria
- Symptomatic, untreated, or actively progressing central nervous system metastases.
- History of leptomeningeal disease.
- History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days.
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Patients receiving any TKI or PD-1/PD-L1 antibody or such combination in a previous treatment line against HCC (except atezolizumab plus bevacizumab combination).
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyteï€associated protein 4 (CTLA-4), anti-PD-1, and anti-PD-L1 (other than atezolizumab) therapeutic antibodies.
- Patients who discontinued atezolizumab in a previous treatment line against HCC primarily for toxicity or intolerability are not eligible for the study.
- Patients on a liver transplantation list.
- Prior allogeneic stem cell or solid organ transplantation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared with lenvatinib or sorafenib alone Tumor assessments will be performed at baseline, every 6 weeks (+1 week) for the first 54 weeks following the initiation of study | treatment, and every 9 weeks (+ 1 week) thereafter, with additional scans as clinically indicated.
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared to lenvatinib or sorafenib alone Assessments per investigator according to RECIST v1.1 To evaluate patient-reported function and GHS/QoL experienced by patients receiving atezolizumab plus lenvatinib or sorafenib versus lenvatinib or sorafenib alone TTD, of HRQoL, defined as the time from randomization to first deterioration (decrease from baseline of more than equal to 10 points) maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks (if Cycle 1-6) or 6 weeks (if after Cycle 6) in the following EORTC QLQ-C30 scales (separately): physical function, role function, and GHS/QoL
Trial Locations
- Locations (4)
Asian Institute of Gastroenterology
🇮🇳Hyderabad, TELANGANA, India
HealthCare Global Enterprises Limited
🇮🇳Bangalore, KARNATAKA, India
Post Graduate Institute of Medical Education & Research
🇮🇳Chandigarh, CHANDIGARH, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Asian Institute of Gastroenterology🇮🇳Hyderabad, TELANGANA, IndiaDr Anand KulkarniPrincipal investigator8553322434anandvk90@gmail.com