What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, particularly those that modulate the immune system like QBECO, can have various side effects. For instance, berberine, used for chemoprevention, primarily causes mild constipation. NSAIDs, including aspirin, which are also used for chemoprevention, can lead to gastrointestinal issues such as ulcers and bleeding. Other general side effects of colorectal cancer treatments may include fatigue, nausea, vomiting, diarrhea, and increased susceptibility to infections due to immune system modulation.

What prior FDA approvals exist?

FDA-approved immunotherapy treatments for colorectal cancer include pembrolizumab (Keytruda) and nivolumab (Opdivo), which are immune checkpoint inhibitors targeting PD-1. These drugs help the immune system recognize and attack cancer cells. Pembrolizumab is approved for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer, while nivolumab is approved for MSI-H or dMMR colorectal cancer that has progressed following chemotherapy.

What other types of research exist?

Promising novel alternatives to QBECO for colorectal cancer patients include immune checkpoint inhibitors such as pembrolizumab and nivolumab, especially for patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). Additionally, combination therapies involving immune checkpoint inhibitors and chemotherapy, such as pembrolizumab plus chemotherapy, have shown efficacy in other cancers and may be considered. Emerging treatments like CAR-T cell therapy and bispecific T-cell engagers (BiTEs) are also being explored in clinical trials for their potential to target colorectal cancer.

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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

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 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

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

Do I qualify?Apply below to find out

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.