AzTrials
AzTrials

Colorectal CancerPhase 2PERIOP-06NCT05677113

A Study of QBECO Versus Placebo in the Treatment of Colorectal Cancer That Has Spread to the Liver

A Phase 2 study testing QBECO in people with Colorectal Cancer and Liver Metastases, run by Sunnybrook Health Sciences Centre at 4 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Liver Metastases
What is being tested?
QBECO
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
115 participants
Where
4 sitesCanada
Study dates
1 Aug 2023to 1 Feb 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Hamilton Health Science Centre

    Hamilton, Ontario

  • London Health Science Centre

    London, Ontario

  • The Ottawa Hospital

    Ottawa, Ontario

  • Sunnybrook Health Science Centre

    Toronto, Ontario, L4H1Z9

Other trials in Canada

About this study

Official title: A Phase II Study of Perioperative QBECO Site Specific Immunomodulator (Qu Biologics®) in Patients With Metastatic Colorectal Adenocarcinoma Within the Liver Undergoing Resection

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.

Read the 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.

Being tested
QBECO, Placebo
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QBECODrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT05677113
Study groupRoleWhat they receive
QBECOExperimentalQBECO 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).
Receives: Drug: QBECO
PlaceboPlacebo comparatorA placebo is a liquid that looks like the study drug, but contains no medication.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome will be the 2-year Progression-Free Survival (PFS) rate

    PFS will be defined as the time from enrollment to the first event that is either locoregional recurrence (of the resected primary colorectal adenocarcinoma or the resected ± intraoperatively ablated metastatic disease), distant metastases, or death from any cause.

    Section 5 further defines PFS and its measurement.

    Measured: 2 years

Secondary outcomes (4)

  1. Clearance of ctDNA.

    A substantial body of research has demonstrated associations between ctDNA and cancer progression.Timing of measurement will be at baseline (which will occur within 14 days prior to the first dose of Investigational Product (IP) and at least 14 days after the last dose of chemotherapy, when applicable), preoperatively on the day of surgery, and postoperatively. A sample of fresh tumour tissue will be obtained from each resected hepatic and extrahepatic (when applicable) tumour site, resection of the primary colorectal carcinoma, along with a sample of normal adjacent tissue (one per surgical specimen) to tailor the ctDNA assay to the individual participant's tumour profile. If tumour tissue is not available from the resected specimen, tumour tissue from a prior resection or biopsy of the participant's adenocarcinoma may be requested. If disease progression is detected, ctDNA will also be measured at that time.

    Measured: 5 years

  2. Side-effect profile of QBECO

    This will include an evaluation of AEs and postoperative complications in the treatment and control groups. A postoperative complication will be defined as any deviation from the normal postoperative course. All clearly related signs, symptoms, and abnormal diagnostic procedures should be recorded in the source document and should be grouped under one diagnosis. The deviation must be possibly or probably related to the surgery and must occur postoperatively. The modified Clavien-Dindo system will be used to define and classify postoperative complications.

    Measured: through study completion, an average of 5 years

  3. Quality of recovery

    Measured by the QoR-40. The QoR-40 is a validated tool designed to measure the early postoperative health status of patients. The tool has been widely used as a patient-reported outcome measure of recovery after surgery and has been translated into multiple languages. Timing of measurement will be at baseline (which will occur within 14 days prior to the first IP dose and at least 14 days after the last dose of chemotherapy, when applicable), on postoperative day (POD) 3, and 6 weeks postoperatively. The survey may be administered in person or virtually by telephone or video call.

    Measured: Baseline; postoperative day 3, and 6 weeks postoperatively

  4. Five-year overall survival

    This will be measured from date of enrollment to the date of death.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start1 Aug 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completion1 Feb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05677113
Sponsor's protocol ID
4023
Acronym
PERIOP-06
Status last verified
Feb 2026
First submitted
4 Nov 2022
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tsuchiya Y, Sawada S, Yoshioka I, Ohashi Y, Matsuo M, Harimaya Y, Tsukada K, Saiki I. Increased surgical stress promotes tumor metastasis. Surgery. 2003 May;133(5):547-55. doi: 10.1067/msy.2003.141.

    PubMed 12773983

  • Tai LH, Zhang J, Scott KJ, de Souza CT, Alkayyal AA, Ananth AA, Sahi S, Adair RA, Mahmoud AB, Sad S, Bell JC, Makrigiannis AP, Melcher AA, Auer RC. Perioperative influenza vaccination reduces postoperative metastatic disease by reversing surgery-induced dysfunction in natural killer cells. Clin Cancer Res. 2013 Sep 15;19(18):5104-15. doi: 10.1158/1078-0432.CCR-13-0246. Epub 2013 Jul 23.

    PubMed 23881927

  • Tai LH, Alkayyal AA, Leslie AL, Sahi S, Bennett S, Tanese de Souza C, Baxter K, Angka L, Xu R, Kennedy MA, Auer RC. Phosphodiesterase-5 inhibition reduces postoperative metastatic disease by targeting surgery-induced myeloid derived suppressor cell-dependent inhibition of Natural Killer cell cytotoxicity. Oncoimmunology. 2018 Mar 1;7(6):e1431082. doi: 10.1080/2162402X.2018.1431082. eCollection 2018.

    PubMed 29872554

  • Tai LH, de Souza CT, Belanger S, Ly L, Alkayyal AA, Zhang J, Rintoul JL, Ananth AA, Lam T, Breitbach CJ, Falls TJ, Kirn DH, Bell JC, Makrigiannis AP, Auer RA. Preventing postoperative metastatic disease by inhibiting surgery-induced dysfunction in natural killer cells. Cancer Res. 2013 Jan 1;73(1):97-107. doi: 10.1158/0008-5472.CAN-12-1993. Epub 2012 Oct 22.

    PubMed 23090117

  • Seth R, Tai LH, Falls T, de Souza CT, Bell JC, Carrier M, Atkins H, Boushey R, Auer RA. Surgical stress promotes the development of cancer metastases by a coagulation-dependent mechanism involving natural killer cells in a murine model. Ann Surg. 2013 Jul;258(1):158-68. doi: 10.1097/SLA.0b013e31826fcbdb.

    PubMed 23108132

  • Ananth AA, Tai LH, Lansdell C, Alkayyal AA, Baxter KE, Angka L, Zhang J, Tanese de Souza C, Stephenson KB, Parato K, Bramson JL, Bell JC, Lichty BD, Auer RC. Surgical Stress Abrogates Pre-Existing Protective T Cell Mediated Anti-Tumor Immunity Leading to Postoperative Cancer Recurrence. PLoS One. 2016 May 19;11(5):e0155947. doi: 10.1371/journal.pone.0155947. eCollection 2016.

    PubMed 27196057

  • Gabrilovich DI. Myeloid-Derived Suppressor Cells. Cancer Immunol Res. 2017 Jan;5(1):3-8. doi: 10.1158/2326-6066.CIR-16-0297.

    PubMed 28052991

  • Manz MG, Boettcher S. Emergency granulopoiesis. Nat Rev Immunol. 2014 May;14(5):302-14. doi: 10.1038/nri3660. Epub 2014 Apr 22.

    PubMed 24751955

  • Angka L, Martel AB, Kilgour M, Jeong A, Sadiq M, de Souza CT, Baker L, Kennedy MA, Kekre N, Auer RC. Natural Killer Cell IFNgamma Secretion is Profoundly Suppressed Following Colorectal Cancer Surgery. Ann Surg Oncol. 2018 Nov;25(12):3747-3754. doi: 10.1245/s10434-018-6691-3. Epub 2018 Sep 5.

    PubMed 30187278

  • Zhang J, Tai LH, Ilkow CS, Alkayyal AA, Ananth AA, de Souza CT, Wang J, Sahi S, Ly L, Lefebvre C, Falls TJ, Stephenson KB, Mahmoud AB, Makrigiannis AP, Lichty BD, Bell JC, Stojdl DF, Auer RC. Maraba MG1 virus enhances natural killer cell function via conventional dendritic cells to reduce postoperative metastatic disease. Mol Ther. 2014 Jul;22(7):1320-1332. doi: 10.1038/mt.2014.60. Epub 2014 Apr 3.

    PubMed 24695102

  • Mitroulis I, Ruppova K, Wang B, Chen LS, Grzybek M, Grinenko T, Eugster A, Troullinaki M, Palladini A, Kourtzelis I, Chatzigeorgiou A, Schlitzer A, Beyer M, Joosten LAB, Isermann B, Lesche M, Petzold A, Simons K, Henry I, Dahl A, Schultze JL, Wielockx B, Zamboni N, Mirtschink P, Coskun U, Hajishengallis G, Netea MG, Chavakis T. Modulation of Myelopoiesis Progenitors Is an Integral Component of Trained Immunity. Cell. 2018 Jan 11;172(1-2):147-161.e12. doi: 10.1016/j.cell.2017.11.034.

    PubMed 29328910

  • Kaufmann E, Sanz J, Dunn JL, Khan N, Mendonca LE, Pacis A, Tzelepis F, Pernet E, Dumaine A, Grenier JC, Mailhot-Leonard F, Ahmed E, Belle J, Besla R, Mazer B, King IL, Nijnik A, Robbins CS, Barreiro LB, Divangahi M. BCG Educates Hematopoietic Stem Cells to Generate Protective Innate Immunity against Tuberculosis. Cell. 2018 Jan 11;172(1-2):176-190.e19. doi: 10.1016/j.cell.2017.12.031.

    PubMed 29328912

  • Netea MG, Joosten LAB, van der Meer JWM. Hypothesis: stimulation of trained immunity as adjunctive immunotherapy in cancer. J Leukoc Biol. 2017 Dec;102(6):1323-1332. doi: 10.1189/jlb.5RI0217-064RR. Epub 2017 Oct 10.

    PubMed 29018149

  • Bazett M, Costa AM, Bosiljcic M, Anderson RM, Alexander MP, Wong SWY, Dhanji S, Chen JM, Pankovich J, Lam S, Sutcliffe S, Gunn H, Kalyan S, Mullins DW. Harnessing innate lung anti-cancer effector functions with a novel bacterial-derived immunotherapy. Oncoimmunology. 2017 Nov 27;7(3):e1398875. doi: 10.1080/2162402X.2017.1398875. eCollection 2018.

    PubMed 29399400

  • Kalyan S, Bazett M, Sham HP, Bosiljcic M, Luk B, Dhanji S, Costa AM, Wong SWY, Netea MG, Mullins DW, Gunn H. Distinct inactivated bacterial-based immune modulators vary in their therapeutic efficacies for treating disease based on the organ site of pathology. Sci Rep. 2020 Apr 3;10(1):5901. doi: 10.1038/s41598-020-62735-z.

    PubMed 32246043

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QBECO in people with Colorectal Cancer and Liver Metastases, run by Sunnybrook Health Sciences Centre at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome will be the 2-year Progression-Free Survival (PFS) rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05677113, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in