A Phase 2/3 interventional study of sunitinib malate and Placebo in Liver Cancer, sponsored by Federation Francophone de Cancerologie Digestive. Completed at 31 sites in France. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by Federation Francophone de Cancerologie Digestive · Phase 2/3, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Pilot: Patients receive oral sunitinib malate once daily on days 1-28. Beginning 7-10 days later, patients undergo 1-3 courses of transarterial chemoembolization (TACE). Treatment repeats every 6 weeks for 1 year.
Randomization: Patients are stratified according to main tumor diameter (\< 5 cm vs ≥ 5 cm), nodular involvement (uninodular vs multinodular), and center. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed periodically.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 78 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Federation Francophone de Cancerologie Digestive is the lead sponsor of 61 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
placebo 3cps/days 4 weeks over 6 during 1 year
Drug: Placebo · Procedure: transarterial chemoembolization
sunitinib (SUTENT®) 37,5 mg/d (3 cps of 12,5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
Drug: sunitinib malate · Procedure: transarterial chemoembolization
placebo 3cps/days 4 weeks over 6 during 1 year
placebo 3cps/days 4 weeks over 6 during 1 year
Chimioembolisation
Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure
The number of patients with at least one bleed and/or liver failure by treatment group
Time frame: Up to 7 days following each TACE, up to 5 months of treatment
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death (from any cause). Patients lost to follow-up or alive at the time of analysis are censored at the last news date or the point date. This time is used to calculate the median follow-up time.
Time frame: From randomization until death or last news for alive patients, up to 3 years
Disease-free Survival
Disease-free survival is defined as the time interval between randomization and local or distant relapse or second cancer or death (all causes). Alive patients are censored at the last follow-up.
Time frame: From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first
78 patients were included by 17 centers
| Milestone | Placebo | Sunitinib |
|---|---|---|
| Started | 39 | 39 |
| Completed | 38 | 39 |
| Not completed | 1 | 0 |
The number of patients with at least one bleed and/or liver failure by treatment group
| percentage of participants | Placebo | Sunitinib |
|---|---|---|
| Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure | 5.88 (0.72 to 19.68) | 2.78 (0.07 to 14.53) |
Overall survival is defined as the time from the date of randomization to the date of death (from any cause). Patients lost to follow-up or alive at the time of analysis are censored at the last news date or the point date. This time is used to calculate the median follow-up time.
| Months | Placebo | Sunitinib |
|---|---|---|
| Overall Survival | 20.5 (15.1 to 30.6) | 25 (13.5 to 36.8) |
Disease-free survival is defined as the time interval between randomization and local or distant relapse or second cancer or death (all causes). Alive patients are censored at the last follow-up.
| Months | Placebo | Sunitinib |
|---|---|---|
| Disease-free Survival | 5.5 (4.1 to 7.8) | 9 (5.8 to 11.6) |
Collected over Up to the end of treatment, on the average of 36 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib | 32/39 (82.1%) | 14/39 (35.9%) | 27/39 (69.2%) |
| Placebo | 30/38 (78.9%) | 13/38 (34.2%) | 36/38 (94.7%) |
| Event | Sunitinib | Placebo |
|---|---|---|
| hyperglycemiaMetabolism and nutrition disorders | 0/39 | 3/38 |
| FeverGeneral disorders | 3/39 | 2/38 |
| Abdominal painGastrointestinal disorders | 2/39 | 0/38 |
| EncephalopathyVascular disorders | 2/39 | 0/38 |
| HyponatremiaMetabolism and nutrition disorders | 0/39 | 1/38 |
| AnorexiaGastrointestinal disorders | 0/39 | 1/38 |
| Black stoolGastrointestinal disorders | 0/39 | 1/38 |
| HemoglobinBlood and lymphatic system disorders | 1/39 | 1/38 |
| BilirubinHepatobiliary disorders | 0/39 | 1/38 |
| Hepatic disorderHepatobiliary disorders | 0/39 | 1/38 |
| Event | Sunitinib | Placebo |
|---|---|---|
| ASATHepatobiliary disorders | 8/39 | 17/38 |
| PlateletsBlood and lymphatic system disorders | 12/39 | 0/38 |
| NeutrophilesBlood and lymphatic system disorders | 11/39 | 0/38 |
| BilirubineHepatobiliary disorders | 10/39 | 5/38 |
| AstheniaGeneral disorders | 9/39 | 2/38 |
| ALATHepatobiliary disorders | 8/39 | 7/38 |
| Increase GGTHepatobiliary disorders | 3/39 | 6/38 |
| LeucocytoseBlood and lymphatic system disorders | 6/39 | 1/38 |
| Liver failureHepatobiliary disorders | 5/39 | 4/38 |
| Hand-foot syndromeSkin and subcutaneous tissue disorders | 5/39 | 0/38 |
| Age, Continuous(years) | Placebo | Sunitinib | Total |
|---|---|---|---|
| Median | 67.4 (43.69 to 82.65) | 65.97 (46.03 to 84.65) | 66.44 (43.69 to 84.65) |
| Sex: Female, Male(Participants) | Placebo | Sunitinib | Total |
|---|---|---|---|
| Female | 4 | 3 | 7 |
| Male | 35 | 36 | 71 |
| Race and Ethnicity Not Collected(Participants) | Placebo | Sunitinib | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Placebo | Sunitinib | Total |
|---|---|---|---|
| France | 39 | 39 | 78 |
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Federation Francophone de Cancerologie Digestive