CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 78 enrolled
Drug / intervention
sunitinib malate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01164202
NCT01164202Phase 3Completed

A Double-Blind, Randomized, Phase II/III Study Comparing the Use of Chemoembolization Combined With Sunitinib Against Chemoembolization Combined With a Placebo in Patients With Hepatocellular Carcinoma (SATURNE)

Federation Francophone de Cancerologie Digestive·interventional·Posted Jul 16, 2010·Updated Mar 18, 2022

In Brief

A Phase 3 clinical trial evaluating sunitinib malate, Placebo, and 1 other intervention for Liver Cancer. Completed, enrolled 78 participants across 31 sites.

Detailed Summary

RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping anticancer drugs near the tumor. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether chemoembolization is more effective with or without sunitinib malate in treating patients with liver cancer. PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization of the liver and to see how well in works when given together with or without sunitinib malate in treating patients with liver cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2010
Enrollment StartJul 1, 2010
Primary CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 16.0 years ago

Interventions

sunitinib malatedrug

placebo 3cps/days 4 weeks over 6 during 1 year

Placebodrug

placebo 3cps/days 4 weeks over 6 during 1 year

transarterial chemoembolizationprocedure

Chimioembolisation