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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05665348
Other study ID # FFCD 2101-PRODIGE 81
Secondary ID 2022-501217-31
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date February 1, 2023
Est. completion date April 1, 2026

Study information

Verified date December 2022
Source Federation Francophone de Cancerologie Digestive
Contact Meriem Guarssifi
Phone 0755675124
Email prodige81.triplet@ffcd.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Drug:
Ipilimumab Injection
Administration of a combine treatment by atezolizumab and bevacizumab, with addition of ipilimumab for patients enrolled in the experimental arm
Atezolizumab Injection
One of the standard treatment's product for HCC management
Bevacizumab
One of the standard treatment's product for HCC management

Locations

Country Name City State
France Chu Henri Mondor Créteil
France Chu Francois Mitterand Dijon
France Chu Dupuytren Limoges
France Chu La Croix Rousse Lyon
France Chu L'Archet Nice
France Chu La Pitie Salpetriere Paris
France Chu Saint Antoine Paris
France Chu Haut Leveque Pessac

Sponsors (1)

Lead Sponsor Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response of treatment (Phase II) Assess the percentage of patients with an objective response (complete response or partial response) according to the investigator (RECIST v1.1) for both treatments arms, 24 months after beginning of treatment
Primary Overall survival (Phase III) The overall survival is defined as the time to death (whatever the cause) or date of last news From randomization until death or last news for alive patients, up to 2 years
Secondary Progression-free survival (PFS) Progression is based on CT-Scan and only radiological progression have to be taking into account. Progression-free survival is defined as the time from randomization to radiological progression or death. Patients alive without progression will be censored at date of last news. From randomization until progression, death or last news for alive patients, up to 2 years
Secondary Objective response rate (OR) under treatment (Phase III) Assess the percentage of patients with an objective response (complete response or partial response) according to the investigator (RECIST v1.1) for both treatments 24 months after beginning of treatment
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