Study Evaluating the Benefit of Adding Ipilimumab to the Combination of Atezolizumab and Bevacizu… (NCT05665348) | Clinical Trial Compass
CompletedPhase 2/3
Study Evaluating the Benefit of Adding Ipilimumab to the Combination of Atezolizumab and Bevacizumab in Patients With Hepatocellular Carcinoma Receiving First-line Systemic Therapy
France229 participantsStarted 2023-03-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 s…
What they're measuring
1
Objective response of treatment (Phase II)
Timeframe: 24 months after beginning of treatment
2
Overall survival (Phase III)
Timeframe: From randomization until death or last news for alive patients, up to 2 years
Trial details
NCT IDNCT05665348
SponsorFederation Francophone de Cancerologie Digestive