Trial Title:
A Study of QBECO Versus Placebo in the Treatment of Colorectal Cancer That Has Spread to the Liver
NCT ID:
NCT05677113
Condition:
Colorectal Cancer
Liver Metastases
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
QBECO
Description:
QBECO is a site specific immunomodulator (SSI) designed to promote innate immune
responses in the gastrointestinal tract and related organs, including the liver. QBECO
will be administered according to the following regimen: 0.1mL self-administered
subcutaneous injections every 2 days for 11-120 days preoperatively, and 41 days
postoperatively.
Arm group label:
QBECO
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo will be prepared in the same way as the IP. Placebo will be administered
according to the following regimen: 0.1mL self-administered subcutaneous injections every
2 days for 11-120 days preoperatively, and 41 days postoperatively.
Arm group label:
Placebo
Summary:
The goal of this type of clinical trial is t to answer the following question: Can the
chance of colorectal cancer progressing be lowered by taking a medication, QBECO, before
and after surgery? The goal of this study is to find out if this approach is better or
worse than the standard of care for your type of cancer. The standard of care is defined
as care most people get for metastatic colorectal cancer. There is currently no standard
of care drug being given before or after surgery to prevent further spread of your
cancer. Participants will be asked to self-inject the study medication before surgery for
minimum of 11 days and after surgery for minimum of 41 days. Participants will be
followed up every 3 months for 2 years, with a final visit at year 5.
Detailed description:
PERIOP-06 is a multicenter, phase II, blinded, randomized, placebo-controlled trial in
adult patients planned to undergo resection of colorectal liver metastases (CRLM) for
complete clearance of all visible disease. The investigational product for the study is
QBECO. QBECO is a site specific immunomodulator (SSI) designed to promote 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 2-year 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 and further
evaluate the use ctDNA as part of ongoing surveillance.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adults aged 18 years or older at time of enrollment.
- Pathologic diagnosis of colorectal carcinoma with clinical diagnosis of liver
metastases
- Planned to undergo resection of liver lesions for complete clearance of all visible
metastatic disease. This will include those who may undergo synchronous resection of
the primary colorectal cancer and/or those who may receive a combination of surgery
and ablation to treat all lesions.
- Computerized Tomography (CT) of the chest, abdomen, and pelvis with intravenous (IV)
contrast within 6 weeks prior to enrollment.
- MRI of the liver within 6 weeks prior to enrollment OR within 6 weeks prior to
starting neoadjuvant chemotherapy (for patients treated with chemotherapy).
- Planned to receive the last dose of neoadjuvant chemotherapy at least 25 days prior
to surgery (for patients treated with neoadjuvant chemotherapy).
- Agree to comply with the contraceptive requirements of the protocol when applicable
- Willing and able to either perform subcutaneous injections according to the study
protocol, or receive the injections from a caregiver delegated by the participant.
- Able to provide informed consent or has a substitute decision maker capable of
providing consent on their behalf.
Exclusion Criteria:
- Prior or current evidence of extrahepatic metastases. Patients with small (<1.0 cm)
indeterminate pulmonary nodules may be included at the investigator's discretion.
- Prior hepatic arterial infusion or embolization. Prior portal vein embolization,
ablation, or liver resection are permitted.
- Patients with any invasive cancer history other than colorectal cancer in the last 5
years. In situ disease (e.g., melanoma in situ, ductal carcinoma in situ of the
breast) or non melanoma skin cancers are permitted.
- Patients with a documented history of clinically severe autoimmune disease or a
syndrome that requires systemic steroids or immunosuppressive agents. This includes
patient requiring systemic treatment with either corticosteroids (> 10 mg daily
prednisone equivalent, or depot corticosteroids in the 6 weeks before enrollment) or
immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporine, etc.)
within the 14 days prior to enrollment or a reasonable expectation that the patient
may require such treatment during the course of the study. Inhaled or topical or
inter-articular steroids, and adrenal replacement steroid doses ≤ 10 mg daily
prednisone equivalent, are permitted in the absence of active autoimmune disease.
Steroids used for premedication prior to chemotherapy or as part of a chemotherapy
regimen are allowed.
- Patients with known active human immunodeficiency virus (HIV), Hepatitis B, or
Hepatitis C infections.
- Pregnant patients or those who are nursing an infant
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hamilton Health Science Centre
Address:
City:
Hamilton
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Meaghan Preston
Email:
prestm1@mcmaster.ca
Investigator:
Last name:
Pablo Serrano, MD
Email:
Principal Investigator
Facility:
Name:
London Health Science Centre
Address:
City:
London
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Crystal Engelage
Email:
crustal.engelage@lhsc.on.ca
Investigator:
Last name:
Anton Skaro, MD
Email:
Principal Investigator
Facility:
Name:
The Ottawa Hospital
Address:
City:
Ottawa
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Rose Leclerc
Email:
roleclerc@ohri.ca
Investigator:
Last name:
Rebecca Auer, MD
Email:
Principal Investigator
Facility:
Name:
Sunnybrook Health Science Centre
Address:
City:
Toronto
Zip:
L4H1Z9
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Paul Karanicolas, MD
Email:
Principal Investigator
Start date:
August 30, 2023
Completion date:
February 1, 2030
Lead sponsor:
Agency:
Sunnybrook Health Sciences Centre
Agency class:
Other
Source:
Sunnybrook Health Sciences Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05677113
http://www.ncbi.nlm.nih.gov/books/NBK6868/
