PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma

ConditionIntrahepatic Cholangiocarcinoma (Icc)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorFederation Francophone de Cancerologie Digestive

About this trial

The goal of this trial is to determine whether the combination of CISGEM and Rilvegostomig during the perioperative period works to improve outcomes of patient undergoing surgery of high-risk of intrahepatic cholangiocarcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

WHO Performance Status 0-1

Body weight > 30kg

Histo/cytologically proven intrahepatic cholangiocarcinoma.

Disqualifiers

Existence of metastases or distant lymph node involvement considered as metastatic

Locally advanced disease considered as definitively non resectable

Cirrhosis with Child Pugh ≥ B7

Any history of liver decompensation: hepatic encephalopathy, presence of ascites

Trial design

Design model

Single group

Treatments tested in this trial

CISGEM + Rilvegostomig
Drug
Administration of 4 cycles pre-operative and 4 cycles post-operative of Cisplatine associated to Gemcitabine with rilvegostomig RILVEGOSTOMIG : For each cycle one administration at D1 every 3 weeks • 750 mg IV administration over 60 minutes (up to a total of 90 minutes). CISGEM: For each cycle administration at D1 and D8 every 3 weeks * Cisplatine 25 mg/m² in 1 hour IV in 1000 ml NaCl 0,9 % then 500 ml NaCl 0,9 % * Gemcitabine 1000 mg/m² en 30 mn IV dans 250 ml NaCl 0,9 %

Treatment groups

49 Participants

are divided into 1 treatment group

Group A: CISGEM + RilvegostomigExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Percentage of patients alive without progression at 12 months

Progression was assessed by the investigator according to RECIST 1.1 criteria based on imaging studies performed every 9 weeks, Clinical progressions, not confirmed on imaging, were not be counted in the primary endpoint. Death for all causes is also an event.

Time frame

12 months after inclusion

Secondary outcomes

Overall survival

Overall survival is defined as the time from the date of inclusion to the patient's death (all causes). For alive patients, the date of the last news will be taken into account.

Time frame

Up to 24 months after inclusion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Federation Francophone de Cancerologie Digestive

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: