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PERIOP-06 Study

Assessment of QBECO SSI Efficacy in the Treatment of Colorectal Cancer That Has Spread to the Liver (PERIOP-06)

Official Title

A Phase II Study of Perioperative QBECO Site Specific Immunomodulator (SSI) in Patients With Metastatic Colorectal Adenocarcinoma Within the Liver Undergoing Resection

Study Overview

PERIOP-06 is a multicenter, phase II, blinded, randomized, placebo-controlled trial in adult patients planned to undergo resection of colorectal cancer liver metastases (CRLM) for complete clearance of all visible disease. The investigational product for the study is QBECO. QBECO is an SSI designed to restore innate immune responses in the gastrointestinal tract and related organs, including the liver. This trial is motivated by the promising preclinical and clinical data supporting the safety and efficacy of QBECO in attenuating postoperative immunosuppression and the resulting proliferation of cancer.

The primary objective of this randomized controlled trial is to determine if QBECO administered perioperatively can improve Progression-Free Survival in adult patients undergoing resection of CRLMs for complete clearance of metastatic disease.

The main secondary objectives will be to:

  1. Determine the effect of QBECO on the frequency and kinetics of clearance (and recurrence) of circulating tumor DNA (ctDNA) in the postoperative period
  2. Determine the side-effect profile of perioperative QBECO
  3. Determine the effect of QBECO on 5-year overall survival

Approximately 115 participants will be randomized to receive a placebo or the investigational product, QBECO. QBECO or placebo will be administered according to the following regimen: 0.1mL subcutaneous injections every two days for 11-120 days preoperatively, and 41 days postoperatively. Participants will be followed for 5 years after surgery.

Treatment Arms

  • QBECO SSI
  • Normal Saline Placebo

Conditions 

  • Colorectal cancer with liver metastases

Locations

  • Toronto, Ontario
    • Sunnybrook Health Science Centre
      • Principal Investigator: Paul Karanicolas, MD, PhD, FRCSC
  • Ottawa, Ontario
    • Ottawa Hospital Research Institute
      • Principal Investigator: Rebecca Auer, MD, MSc, FRCSC
Sponsor

Qu Biologics Inc.

Funding Provided By
  • Qu Biologics
  • Accelerated Clinical Trials Network

Posted on ClinicalTrials.gov