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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

Summary

This trial tests if QBECO, an immune-boosting injection, can lower the risk of colorectal cancer returning after surgery in adults. The medication aims to strengthen the immune system in the gut and liver, potentially preventing cancer recurrence.

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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The will be the 2-year Progression-Free Survival (PFS) rate
Secondary study objectives
Clearance of ctDNA.
Five-year overall survival
Quality of recovery
+1 more

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as FOLFOX (oxaliplatin, fluorouracil, and leucovorin), works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, like cetuximab and bevacizumab, inhibit specific molecules involved in cancer growth and angiogenesis, respectively. Immunotherapy, which is similar to the QBECO trial, aims to enhance the body's immune response against cancer cells. This is crucial for colorectal cancer patients as it offers a way to potentially reduce cancer progression and improve survival rates by leveraging the body's natural defense mechanisms.
Omega-3 polyunsaturated fatty acids: moving towards precision use for prevention and treatment of colorectal cancer.Anthocyanins in Colorectal Cancer Prevention. A Systematic Review of the Literature in Search of Molecular Oncotargets.Gene expression changes in colon tissues from colorectal cancer patients following the intake of an ellagitannin-containing pomegranate extract: a randomized clinical trial.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
673 Previous Clinical Trials
1,565,752 Total Patients Enrolled
Paul KaranicolasPrincipal InvestigatorPaul.Karanicolas@sunnybrook.ca
~20 spots leftby Feb 2025