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QBECO for Colorectal Cancer with Liver Metastases (PERIOP-06 Trial)

Phase 2

Recruiting

Led By Paul Karanicolas

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

PERIOP-06 Trial Summary

This trial tests if an injection can help prevent colorectal cancer from progressing. Participants will self-inject the medication before and after surgery and will be monitored for 2 years.

Who is the study for?

Adults with colorectal cancer that has spread to the liver, who are planning surgery for it and can self-inject or have someone to inject a study medication. They must not be pregnant, nursing, have other cancers within 5 years (except certain skin cancers), severe autoimmune diseases requiring steroids or immunosuppressants, or active HIV/Hepatitis B/C.Check my eligibility

What is being tested?

The trial is testing QBECO injections against a placebo in patients with metastatic colorectal cancer to the liver. Participants will self-inject QBECO or placebo before and after their surgery for at least 11 days pre-surgery and 41 days post-surgery. The study aims to see if this treatment prevents cancer progression better than current standard care.See study design

What are the potential side effects?

Specific side effects of QBECO are not detailed here but may include typical reactions related to injection sites such as pain, swelling, redness; systemic reactions like fever could also occur due to immune response stimulation.

PERIOP-06 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The will be the 2-year Progression-Free Survival (PFS) rate

Secondary outcome measures

Clearance of ctDNA.

Five-year overall survival

Quality of recovery

+1 more

PERIOP-06 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: QBECOExperimental Treatment1 Intervention

QBECO is an SSI formulated from inactivated E. coli bacteria that is specifically designed to target pathologies of the gastrointestinal (GI) tract and related organs, such as the liver. This trial will test the hypothesis that in patients undergoing resection of colorectal liver metastases (CRLMs), perioperative treatment with QBECO will attenuate the postoperative immune suppression and will improve progression-free survival (PFS).

Group II: PlaceboPlacebo Group1 Intervention

A placebo is a liquid that looks like the study drug, but contains no medication.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

QBECO

2013

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,193 Total Patients Enrolled

Paul KaranicolasPrincipal InvestigatorPaul.Karanicolas@sunnybrook.ca

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards are associated with QBECO consumption?

"The safety of QBECO was rated a 2 on Power's scale since there is already evidence indicating its security but no proof yet that it can be effective."

Answered by AI

How many individuals are currently participating in this clinical experiment?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this experiment, which was first uploaded to the website on August 30th 2023, is in the process of recruiting patients. 115 participants are needed from 1 medical site."

Answered by AI

Is there presently any opportunity to join this trial?

"The latest information from clinicaltrials.gov affirms that this clinical trial is seeking participants, having first been posted on August 30th 2023 and most recently updated the following week."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of QBECO Versus Placebo in the Treatment of Colorectal Cancer That Has Spread to the Liver

2023. "A Study of QBECO Versus Placebo in the Treatment of Colorectal Cancer That Has Spread to the Liver". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05677113.