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CholangiocarcinomaPhase 2REACHINNCT02162914

Regorafenib Versus Placebo to Treat Cholangiocarcinoma

A Phase 2 study testing Regorafenib/active in people with Cholangiocarcinoma, run by Erasme University Hospital at 12 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma
What is being tested?
Regorafenib/active
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
12 sitesBelgium
Study dates
14 Mar 2014to Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically proven intra-hepatic or hilum cholangiocarcinoma (mass forming, not "liniting" tumor), locally advanced unresectable or metastatic
  • progression documented after GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum-based (CDDP or oxaliplatin) chemotherapy
  • age > 18 years
  • ECOG PS 0/1 at study entry
  • measurable disease according to RECIST version 1.1
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirementsconducted within 7 days of starting to study treatment:
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  • oSerum creatinine <1.5x upper reference range
  • oTotal bilirubin <1.5x ULN
  • oAlanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5x ULN (<5x ULN forpatients with liver involvement of their cancer).
  • oAmylase and lipase <1.5x ULN.
  • life expectancy of at least 12 weeks
  • effective contraception for both male and female patients if the risk of conception exists
  • negative proteinuria on dipstick or 24 hours proteinuria<1000mg
  • signed written informed consent

Who cannot join

  • unability to take oral medication
  • any malabsorption condition
  • patients taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg. Clarithromycin, indinavir,itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,voriconazole) or strong CYP3A4 inducers (eg. Carbamazepine, phenobarbital, phenytoin, rifampin, St-John's Wort) (see section 8)
  • persistent proteinuria >3.5g/24 hours measured by urine protein-creatinine ratio from a random urinesample (persistent proteinuria >3 non-healing woud, ulcer, or bone fracture
  • any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of studymedication
  • interstitial lund disease with ongoing signs and symptoms at the time of informed consent
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  • uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
  • history of myocardial infarction, deep venous or arterial thrombosis, cerebrovascular accident (CVA) during the last 6 months
  • previous exposure to anti-VEGF targeting therapy (including Regorafenib) and to signal transduction inhibitors
  • known hypersensitivity to any of the components of study treatments
  • previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
  • pregnant or lactating women, or patients of both genders with procreative potential not using adequate contraceptive methods
  • medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
  • unstable angina, congestive heart failure ≥NYHA class II
  • uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg)
  • pheochromocytoma
  • HIV infection
  • active chronic hepatitis B or C with a need for antiviral treatment
  • liver failure, cirrhosis Chil Pugh B or C
  • brain metastasis
  • major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment
  • intra-hepatic locoregional therapy (DC Beads, SIRT)
  • history of organ allograft
  • ongoing infection
  • renal failure requiring dialysis
  • patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Belgium12 sites

  • University Hospitals of Antwerp

    Antwerp, 2650

  • AZ St-Lucas Brugge

    Bruges, 8310

  • Erasme University Hospital

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • AZ St-Lucas Gent

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • CH Jolimont

    Haine-Saint-Paul, Hainaut, 7100

  • AZ Groeninge

    Kortrijk, 8500

  • CHC St-Joseph

    Liège, 4000

  • Hôpital Ambroise Paré

    Mons, 7000

  • CMSE

    Namur, 5000

Other trials in Belgium

About this study

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.

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).

Read the detailed description

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).

Being tested
Regorafenib/active, Regorafenib/placebo
Keywords
Intra-hepatic, Hilar, Locally Advanced, Non Resectable, Metastatic, Regorafenib, Placebo
Medical subject headings
Cholangiocarcinoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regorafenib/activeDrug

    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

  • Regorafenib/placeboDrug

    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

Study groups in NCT02162914
Study groupRoleWhat they receive
Regorafenib/activeActive comparatorSubjects 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.
Receives: Drug: Regorafenib/active
Regorafenib/placeboPlacebo comparatorSubjects 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.
Receives: Drug: Regorafenib/placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improve median PFS

    The primary endpoint is to improve median PFS from 6 weeks to 12 weeks in Regorafenib group.

    Measured: 6 to 12 weeks

Secondary outcomes (5)

  1. Evaluation of response rate

    -Evaluation of tumor response will be done based on radiological RECIST criteria version 1.1 evaluation (thoraco-abdominal CT scan);

    Measured: At pretreatment visit (14 to 1 days before treatment initiation), every 6 weeks for 3 times then every 8 weeks until progression

  2. Correlation between radiological response and metabolic response

    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.

    Measured: At pretreatment visit (14 to 1 days before treatment initiation)

  3. Correlation between radiologic response rate and "Dynamic tumor response rate"

    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);

    Measured: At day 1 (pre-treatment) and day 15 of cycle 1

  4. Correlation between dynamic tumor response rate and metabolic response rate

    Correlation between dynamic tumor response rate and metabolic response rate (Pet CT) when first Pet CT is positive

    Measured: At cycle 1 day 15

  5. Evaluation of Overall Survival (OS)

    Evaluation of OS at one year.

    Measured: After 1 year (March 2015)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2014 (estimated)
  2. Study start14 Mar 2014
  3. Primary completionMar 2019
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02162914
Sponsor's protocol ID
2012-005626-30
Acronym
REACHIN
Status last verified
Jul 2020
First submitted
26 May 2014
Last updated
31 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • Demols A, Borbath I, Van den Eynde M, Houbiers G, Peeters M, Marechal R, Delaunoit T, Goemine JC, Laurent S, Holbrechts S, Paesmans M, Van Laethem JL. Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: REACHIN, a randomized, double-blind, phase II trial. Ann Oncol. 2020 Sep;31(9):1169-1177. doi: 10.1016/j.annonc.2020.05.018. Epub 2020 May 25.

    PubMed 32464280

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib/active in people with Cholangiocarcinoma, run by Erasme University Hospital at 12 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improve median PFS (time frame: 6 to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02162914, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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