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Can a Cancer-Fighting virus shrink tumors when chemo fails?

NCT ID NCT01394939

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests an experimental virus-based therapy called JX-594 (Pexa-Vec) in people with advanced colorectal cancer that has not responded to standard treatments. The virus is designed to infect and kill cancer cells while also stimulating the immune system. It is given alone or combined with the chemotherapy drug irinotecan. The study aims to see if this approach can shrink tumors and help patients live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JX-594 (Pexa-Vec), a modified vaccinia virus, given alone or with the chemotherapy drug irinotecan
What this could lead to
If successful, this could offer a new treatment option for people with advanced colorectal cancer who have run out of standard therapies, potentially slowing tumor growth and extending survival.
What could go wrong
This is an early-phase trial, so the treatment may not work or may cause significant side effects. The virus-based approach is experimental, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

52 people

The number who actually took part.

Start date

Jan 2012

Finished

Oct 2015

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator * Failed treatment with irinotecan * Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab (Vectibix) or had contradictions to treatment * Regorafenib-naïve (have not received regorafenib) * Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2 * Measurable tumor (≥1 cm longest diameter) * Acceptable health status as determined by the investigator and blood work (Chemistry, Complete Blood Count, Coagulation) Exclusion Criteria: * Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or Combination Expansion Arm) * Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if assigned to combination arm) * Significant immunodeficiency due to underlying illness and/or medication * History of severe exfoliative skin condition requiring systemic therapy within the past 2 years * Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions * Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months * Viable Centrual Nervous System (CNS) malignancy associated with clinical symptoms * Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for mitomycin c or nitrosoureas) * Prior participation in any other research protocol involving an investigational medicinal product within 4 weeks prior to first treatment * Use of prohibited anti-viral medication, interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose * Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments. * Pregnant or nursing an infant * Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Billings Clinic Cancer Center

    Billings, Montana, 59101, United States

  • Gabrail Cancer Center

    Canton, Ohio, 44718, United States

  • Hôpital Hautepierre

    Strasbourg, 67200, France

  • Hôpital Saint Antoine

    Paris, 75012, France

  • Institut Claudius Regaud

    Toulouse, 31052, France

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2, Canada

  • Mayo Clinic

    Scottsdale, Arizona, 85259-5499, United States

  • Ottawa Hospital and Research Institute (OHRI)

    Ottawa, Ontario, K1H 8L6, Canada

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UCSD Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-1651, United States

More trials for these conditions

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