Randomised, Open-label, Phase II-III Study Evaluating the Benefit of Adding Ipilimumab to the Combination of Atezolizumab and Bevacizumab in Patients With Hepatocellular Carcinoma Receiving First-line Systemic Therapy

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

TRIPLET HCC is a phase II-III trial that assess the effectivness of addition of ipilimumab to the combination atezolizumab-bevacizumab, on global survival and response to the treatment, for patients with advanced or metastatic hepatocellular carcinoma. The theoretical duration of the study is 5 years. In the scope of this study, each patient will have 2 years of treatment and 2 years of follow-up from their enrollment date.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Histologically proven hepatocellular carcinoma (HCC) on biopsy less than two years old. If no histological evidence, a tumour (mandatory) and non-tumour (optional) liver biopsy is required.

• WHO 0 or 1

• HCC not amenable to curative treatment by surgery, thermo-ablation or liver transplantation, or to intra-arterial palliative treatment (IAP) for intermediate BCLC-B HCC.

⁃ Advanced (BCLC-C) or intermediate (BCLC-B) HCC after failure or contraindication of the CEL

• Normal Troponin-T

• Patients with controlled cardiovascular disease for at least 6 months

• No clinically evident ascites, no history of clinical ascites, or encephalopathy due to liver failure

• Adequate liver function: AST and ALT ≤ 5 x ULN (upper normal limit), total bilirubin ≤ 35 µM/L, albumin ≥ 28 g/L and Child-Pugh A score (if associated cirrhosis)

• Hematological (hemoglobin \> 8.5 g/dL, platelets \> 60 G/L, PNN \> 1.5 G/L) and renal function (creatinine clearance ≥ 40ml/min according to the appropriate MDRD formula)

• At least one target lesion measurable according to RECIST v1.1 criteria

• Oesophageal endoscopy less than 6 months old. All patients with varicose veins of any grade should be treated with β-blockers prior to initiation of therapy, in the absence of contraindications.

• Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sex with women of childbearing potential must agree to use contraception during treatment and for at least 6 months after discontinuation of the experimental treatments

• Ability of the patient to understand, sign and date the informed consent form before randomisation

• Patient affiliated to a social security scheme

Locations
Other Locations
France
Chu Henri Mondor
RECRUITING
Créteil
Chu Francois Mitterand
RECRUITING
Dijon
Chu Dupuytren
RECRUITING
Limoges
Chu La Croix Rousse
RECRUITING
Lyon
Chu L'Archet
RECRUITING
Nice
Chu La Pitie Salpetriere
RECRUITING
Paris
Chu Saint Antoine
RECRUITING
Paris
Chu Haut Leveque
RECRUITING
Pessac
Contact Information
Primary
Meriem Guarssifi
prodige81.triplet@ffcd.fr
0755675124
Backup
Marie Moreau
marie.moreau@u-bourgogne.fr
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 574
Treatments
Active_comparator: DOULET ATEZOLIZUMAB-BEVACIZUMAB
Standard treatment of HCC by the combination atezolizumab-bevacizumab, 1 cure each 3 weeks during 24 months
Experimental: TRIPLET ATEZOLIZUMAB BEVACIZUMAB IPILIMUMAB
Standard treatment of HCC by the combination atezolizumab-bevacizumab with addition of ipilimumab for the 4 firsts cures of treatment each 3 weeks, then only treatment by the doublet atezolizumab-bevacizumab each 3 weeks. The total duration of treatment is 24 months.
Related Therapeutic Areas
Sponsors
Leads: Federation Francophone de Cancerologie Digestive

This content was sourced from clinicaltrials.gov