QBECO for Colorectal Cancer with Liver Metastases

(PERIOP-06 Trial)

Recruiting at 3 trial locations

Overseen By Hal Gunn

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Extrahepatic metastases, Invasive cancer, Autoimmune, HIV, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic steroids or immunosuppressive drugs, you may need to stop them before joining the trial.

Research Team

Paul Karanicolas

Principal Investigator

[e-mail]

Eligibility Criteria

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.

Inclusion Criteria

I will finish my pre-surgery chemotherapy 25 days before my surgery.

I've had a CT scan with contrast of my chest, abdomen, and pelvis within the last 6 weeks.

Agree to comply with the contraceptive requirements of the protocol when applicable

Exclusion Criteria

I have had no cancer other than colorectal in the last 5 years, except for skin cancers or in situ cancers.

My cancer has spread beyond the liver, but I might have small lung nodules.

Pregnant patients or those who are nursing an infant

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants self-inject QBECO or placebo every two days for 11-120 days before surgery

11-120 days

Postoperative Treatment

Participants continue to self-inject QBECO or placebo every two days for 41 days after surgery

41 days

Follow-up

Participants are monitored for safety and effectiveness every 3 months for 2 years, with a final visit at year 5

5 years

Treatment Details

Interventions

• Placebo (Other)
• QBECO (Other)

Trial Overview 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.

Participant Groups

Group I: QBECO Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+