Phase 3 Liver Cancer Trial, Terminated NCT01939223 Sponsor: Bayer Condition: Liver Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT01939223) enrolled 25 people in total — 14 in the group receiving Regorafenib 160 mg and 11 in the placebo group. The trial was designed to measure two things: first, how long participants remained free of their disease returning after treatment (called "disease-free survival"), and second, how long participants lived overall ("overall survival"). Only 1 participant in the Regorafenib group and none in the placebo group were recorded as having completed the study; the remaining participants did not complete it, though the reasons are not detailed in the data provided here. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for either the primary outcome (disease-free survival) or the secondary outcome (overall survival). In other words, while the trial tracked how long people went without their disease coming back and how long they lived, the actual figures for both of these measures were not reported in the structured results data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Liver Cancer Trial, Terminated

NCT01939223
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with a type of colorectal cancer called adenocarcinoma (a cancer that started in the colon or rectum).
  • Your cancer had spread (Stage IV), but only to the liver — not to other parts of the body.
  • You have had surgery with the goal of fully removing both your colorectal cancer and your liver tumors, with no cancer left at the edges of what was removed.
  • You have received chemotherapy for a required minimum period (at least 3 months, but no more than 9 months total), including specific drug combinations — the exact requirements depend on your situation, so confirm the details with the trial site.
  • Your cancer type has been confirmed by laboratory testing to be adenocarcinoma (including subtypes like mucinous adenocarcinoma).
  • Your bone marrow, liver, and kidneys are working well enough, as shown by blood test results taken within 7 days before starting the study drug (confirm specific values with the trial site).
  • You have had a CT or MRI scan of your chest, abdomen, and pelvis within 4 weeks before joining the trial.
  • You are generally well enough to carry out daily activities with little or no limitation (this is measured using a standard scale called ECOG — a score of 0 or 1 is required).
  • If you are a woman who could become pregnant, or a man, you agree to use effective contraception from the time you sign the consent form until 8 weeks after your last dose of the study drug.

Who may not be able to join:

  • You are currently taking certain strong medications that affect how the body processes drugs — including some antifungals, antivirals, antibiotics, anti-seizure medicines, or St. John's Wort (confirm the full list with the trial site).
  • You have used certain immune-boosting injections (such as white blood cell growth factors) within 3 weeks before signing the consent form.
  • You have previously been treated with regorafenib or similar drugs that target a protein called VEGFR.
  • You received more than 6 months of anti-cancer treatment after your liver surgery.
  • You received certain targeted biological therapies (such as drugs targeting VEGFR or EGFR) after your liver surgery, unless those treatments began before surgery and continued only to finish a pre-planned number of doses.
  • Your last chemotherapy dose or last cancer surgery happened more than 10 weeks before joining the trial (whichever happened later).
  • Your cancer has spread to parts of the body other than the liver.
  • You have received any systemic anti-cancer treatment within 4 weeks before starting the study drug.
  • You are currently pregnant or breastfeeding.
  • You have had a different type of cancer in the last 5 years, with some exceptions such as certain early-stage or non-invasive cancers that were fully treated (confirm with trial site).
  • You have moderate to severe heart failure, recent unstable chest pain, or a heart attack within the last 6 months.
  • You have a heart rhythm problem that requires medication to control (except for beta blockers or digoxin).
  • You have high blood pressure that is not well controlled, even with medication.
  • You have a rare adrenal gland tumor called pheochromocytoma.
  • You have had a stroke, blood clot in a vein, or a blood clot in the lungs within the last 6 months.
  • You have a known HIV infection.
  • You have active or ongoing hepatitis B or C that requires antiviral treatment.
  • You have a seizure condition that requires medication.
  • You have any history of abnormal bleeding or a bleeding disorder, even if mild.
  • You have had a serious bleeding event within 4 weeks before starting the study drug.
  • You have any other serious illness or condition that could affect your safety or ability to participate in the trial (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Terminated
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
2 December 2013
Est. completion
29 August 2016

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇵🇹 Portugal 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Disease Free Survival (DFS) as Assessed by the Investigator

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov