Regorafenib Versus Placebo to Treat Cholangiocarcinoma (REACHIN)
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|ClinicalTrials.gov Identifier: NCT02162914|
Recruitment Status : Active, not recruiting
First Posted : June 13, 2014
Last Update Posted : March 20, 2019
The study is a multicenter randomized (1:1) placebo-controlled, double-blinded phase II trial aiming to demonstrate an improvement of median PFS when treating locally advanced unresectable or metastatic patients suffering from an intra-hepatic or hilum (mass-forming) cholangiocarcinoma with Regorafenib as compared to placebo, and after progression after GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum (CDDP or oxaliplatin)-based chemotherapy.
The principal objective is to investigate Regorafenib efficacy by prospectively evaluating the PFS after the administration of Regorafenib combined with BSC as compared to placebo with BSC. Hypothesis is a 50% improvement in median PFS (from 6 weeks to 12 weeks in Regorafenib group).
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma||Drug: Regorafenib/active Drug: Regorafenib/placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||REGORAFENIB AFTER FAILURE OF GEMCITABINE AND PLATINUM-BASED CHEMOTHERAPY FOR LOCALLY ADVANCED (NON RESECTABLE) AND METASTATIC INTRA-HEPATIC OR HILAR CHOLANGIOCARCINOMA: A Randomized Double-blinded Phase II Trial.|
|Actual Study Start Date :||March 14, 2014|
|Actual Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Regorafenib/active
Subjects randomized to be treated with Regorafenib (active product) will receive once a day 160 mg po (four tablets of 40 mg) for 3 weeks of every 4 weeks cycle (3 weeks on and 1 week off). Duration of one cycle is 28 days.
Subjects randomized to be treated with Regorafenib/active will receive once a day 160 mg po (four tablets of 40 mg) for 3 weeks of every 4 weeks cycle (3 weeks on and 1 week off) Duration of one cycle is 28 days
Placebo Comparator: Regorafenib/placebo
Subjects randomized to be treated with Regorafenib (placebo) will receive once a day 160 mg po (four tablets of 40 mg) for 3 weeks of every 4 weeks cycle (3 weeks on and 1 week off). Duration of one cycle is 28 days.
Subjects randomized to be treated with Regorafenib/placebo will receive once a day 160 mg po (four tablets of 40 mg) for 3 weeks of every 4 weeks cycle (3 weeks on and 1 week off) Duration of one cycle is 28 days
- Improve median PFS [ Time Frame: 6 to 12 weeks ]The primary endpoint is to improve median PFS from 6 weeks to 12 weeks in Regorafenib group.
- Evaluation of response rate [ Time Frame: At pretreatment visit (14 to 1 days before treatment initiation), every 6 weeks for 3 times then every 8 weeks until progression ]-Evaluation of tumor response will be done based on radiological RECIST criteria version 1.1 evaluation (thoraco-abdominal CT scan);
- Correlation between radiological response and metabolic response [ Time Frame: At pretreatment visit (14 to 1 days before treatment initiation) ]Correlation between radiological response (using RECIST criteria version 1.1) and metabolic response using PET imaging (SUV max modifications). This will only be done if SUV max of the tumor inside the liver at pre-treatment visit is ≥ 175% of the SUV max of the normal liver.
- Correlation between radiologic response rate and "Dynamic tumor response rate" [ Time Frame: At day 1 (pre-treatment) and day 15 of cycle 1 ]Correlation between radiologic response rate (RECIST criteria version 1.1) and "Dynamic tumor response rate". Dynamic response rate is defined by a 20% modification of tumoral perfusion status determined by quantitative DCE-MRI after 14 days of treatment (D1 compared to D15 values);
- Correlation between dynamic tumor response rate and metabolic response rate [ Time Frame: At cycle 1 day 15 ]Correlation between dynamic tumor response rate and metabolic response rate (Pet CT) when first Pet CT is positive
- Evaluation of Overall Survival (OS) [ Time Frame: After 1 year (March 2015) ]Evaluation of OS at one year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162914
|Haine-Saint-Paul, Hainaut, Belgium, 7100|
|University Hospitals of Antwerp|
|Antwerp, Belgium, 2650|
|AZ St-Lucas Brugge|
|Brugge, Belgium, 8310|
|Erasme University Hospital|
|Brussels, Belgium, 1070|
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Grand Hôpital de Charleroi|
|Charleroi, Belgium, 6000|
|AZ St-Lucas Gent|
|Gent, Belgium, 9000|
|Gent, Belgium, 9000|
|Kortrijk, Belgium, 8500|
|Liège, Belgium, 4000|
|Hôpital Ambroise Paré|
|Mons, Belgium, 7000|
|Namur, Belgium, 5000|
|Principal Investigator:||Anne Demols, MD, PhD||Erasme University Hospital|