Locally Advanced Rectal CancerPhase 2IMPERIANCT07645118
Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer
A Phase 2 study testing Nivolumab, HDRBET and Total Mesorectal Excision (TME) in people with Locally Advanced Rectal Cancer, run by Dr. Te Vuong at 1 site in Canada.
Trial summary
This is a small Phase II study testing whether targeted internal radiation treatment (HDREBT) followed by two doses of the immunotherapy drug Nivolumab is safe, practical, and potentially effective before patients undergo surgery (TME) to remove rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Nivolumab, HDRBET and Total Mesorectal Excision (TME)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to Dec 2030
- 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
- Age ≥18 years at the time of consent.
- Histologically confirmed rectal adenocarcinoma arising within 5 to 15 cm of the anal verge as measured by sigmoidoscopy or MRI.
- Rectal cancer staging:
- Clinical Stage cT2 or cT3 based on high resolution pelvic MRI;
- No evidence of distant metastases (cM0) on contrast -enhanced CT of chest, abdomen and pelvis (or PET/CT if clinically indicated);
- Disease deemed technically resectable with curative intent by multidisciplinary tumor board (MDT)*. No radiologic evidence of unresectable local disease (e.g., tumor fixation or invasion of adjacent unresectable structures).
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- At least one of the following adverse prognostic features observed on baseline MRI:
- Node-positive disease (cN+);
- Threatened mesorectal fascia (MRF) defined as distance from tumor to mesorectal fascia < 1mm on pelvic MRI;
- Extramural venous invasion (EMVI+).
- Proficient mismatch repair (pMMR) status, as determined by immunohistochemistry and/or microsatellite instability-low (MSI-L) status by next-generation sequencing
- Planned management includes neoadjuvant therapy with radiotherapy followed by curative-intent TME.
- Prior external beam pelvic radiation for other malignancy (prostate, gynecology, lymphoma, bladder) are acceptable, provided the colorectal surgeon deems the patient as a candidate for TME surgery.
- ECOG performance status of 0-2
- Adequate organ function, defined by:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin ≥ 90 g/L
- Estimated creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's syndrome who may only be included with total bilirubin ≤ 3.0 x ULN)
- Aspartate transaminase (AST) ≤ 3.0 x ULN
- Alanine transaminase (ALT) ≤ 3.0 x ULN
- INR ≤ 1.5 ULN
- aPTT and PT ≤ 1.5 ULN
- Albumin ≥ 25 g/L
- Ability to understand, willing to provide written informed consent, and to comply with study requirements.
Who cannot join
- Prior anticancer therapy for rectal cancer.
- Contraindication to safe MRI imaging.
- Evidence of bowel obstruction on MRI or clinical evaluation.
- Evidence of distant metastasis.
- Medical or surgical contraindications to major pelvic surgery
- Active autoimmune disease requiring systemic immunosuppressive therapy.
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- Active/uncontrolled infection. Infectious screening for HIV, Hepatitis B (HBV), Hepatitis C (HBC) and tuberculosis will be performed at screening:
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks; and have undetectable HBV viral load prior to starting treatment. Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
- Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to start of treatment.
- HIV-infected participants must have well-controlled HIV on antiretroviral treatment (ART), defined as:
- have a CD4+ T-cell count ≥ 0.35 x109 cells/L at the time of screening. ii. must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.
- must not have had any AIDS-defining opportunistic infections within the past 12 months.
- must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before start of treatment and agree to continue ART throughout the study.
- Known allergy or hypersensitivity to nivolumab or any of its excipients.
- Patients with other psychiatric, social or severe or uncontrolled medical conditions that in the opinion of the investigator may compromise their compliance with the protocol or may represent an unacceptable risk to their safety (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant cardiovascular disease).
- Requirement for prohibited concomitant medication, as outlined in section 8.4 within 14 days prior to first brachytherapy treatment.
- Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 28 days of first neo-adjuvant treatment.
- Patients who are pregnant or breastfeeding or WOCBP not employing an effective method of birth control.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Study Coordinator, 514-340-8222, ivgenya.kosenko.ccomtl@ssss.gouv.qc.ca
About this study
Official title: Pilot Evaluation of the Immunogenic Potentiation of Neo-adjuvant Brachytherapy Followed by Nivolumab Immunotherapy Without Chemotherapy in Stage II/III Locally Advanced Mismatch Repair Proficient Rectal Cancer
This is a small Phase II study testing whether targeted internal radiation treatment (HDREBT) followed by two doses of the immunotherapy drug Nivolumab is safe, practical, and potentially effective before patients undergo surgery (TME) to remove rectal cancer.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Nivolumab, HDRBET, Total Mesorectal Excision (TME)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
2 doses of nivolumab 3 mg/kg mg IV every 2 weeks
HDRBETDevice
26 Gy in 4 fractions Administered over Days 1-4 as per institutional standard
Total Mesorectal Excision (TME)Procedure or surgery
Targeted to take place 6-8 weeks post completion of HDREBT (maximum 12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Brachytherapy (HDREBT) followed by nivolumab and total mesorectal excision | Experimental | HDREBT (26 Gy delivered in 4 fractions over Days 1-4) followed by up to 2 doses of nivolumab (3 mg/kg mg IV every 2 weeks starting at 7-14 days post HDREBT). Surgical resection of tumor (6-8 weeks post HDREBT) Receives: Drug: Nivolumab; Device: HDRBET; Procedure: Total Mesorectal Excision (TME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
Measured: This is assessed at the time of total mesorectal excision surgery, occurring approximately 12 weeks after enrollment.
Secondary outcomes (2)
Incidence and severity of adverse events, as per CTCAE criteria v6.0
Measured: From time of first treatment through 90 days following last treatment with nivolumab
Assess feasibility of treatment sequence
Completion of treatment of all treatment modalities within protocol-defined timeframes (brachytherapy, immunotherapy and surgery)
Measured: This is assessed from the time of enrollment until the time of surgery, approximately 12 weeks after enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Te Vuong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645118
- Sponsor's protocol ID
- IMPERIA-01
- Acronym
- IMPERIA
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vuong T, Devic S, Podgorsak E. High dose rate endorectal brachytherapy as a neoadjuvant treatment for patients with resectable rectal cancer. Clin Oncol (R Coll Radiol). 2007 Nov;19(9):701-5. doi: 10.1016/j.clon.2007.07.006. Epub 2007 Aug 22.
PubMed 17714925Lin ZY, Zhang P, Chi P, Xiao Y, Xu XM, Zhang AM, Qiu XF, Wu JX, Yuan Y, Wang ZN, Qu XJ, Li X, Nie X, Yang M, Cai KL, Zhang WK, Huang Y, Sun Z, Hou ZG, Ma C, Cheng FZ, Tao KX, Zhang T. Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial. Ann Oncol. 2024 Oct;35(10):882-891. doi: 10.1016/j.annonc.2024.06.015. Epub 2024 Jul 2.
PubMed 38964714
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Immunogenic Potentiation of Neo-adjuvant Brachytherapy Followed by Nivolumab Immunotherapy Without Chemotherapy in Stage II/III Locally Advanced Mismatch Repair Proficient Rectal Cancer
- ClinicalTrials.gov ID
- NCT07645118
- Acronym / sponsor ID
- IMPERIA / IMPERIA-01
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dr. Te VuongUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a small Phase II study testing whether targeted internal radiation treatment (HDREBT) followed by two doses of the immunotherapy drug Nivolumab is safe, practical, and potentially effective before patients undergo surgery (TME) to remove rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brachytherapy (HDREBT) followed by nivolumab and total mesorectal excision | Experimental | Drug: Nivolumab, Device: HDRBET, Procedure: Total Mesorectal Excision (TME)HDREBT (26 Gy delivered in 4 fractions over Days 1-4) followed by up to 2 doses of nivolumab (3 mg/kg mg IV every 2 weeks starting at 7-14 days post HDREBT). Surgical resection of tumor (6-8 weeks post HDREBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Age ≥18 years at the time of consent.
- Histologically confirmed rectal adenocarcinoma arising within 5 to 15 cm of the anal verge as measured by sigmoidoscopy or MRI.
- Rectal cancer staging:
- At least one of the following adverse prognostic features observed on baseline MRI:
- Proficient mismatch repair (pMMR) status, as determined by immunohistochemistry and/or microsatellite instability-low (MSI-L) status by next-generation sequencing
Key exclusion criteria (18 listed)
- Prior anticancer therapy for rectal cancer.
- Contraindication to safe MRI imaging.
- Evidence of bowel obstruction on MRI or clinical evaluation.
- Evidence of distant metastasis.
- Medical or surgical contraindications to major pelvic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab2 doses of nivolumab 3 mg/kg mg IV every 2 weeks | Drug | Brachytherapy (HDREBT) followed by nivolumab and total mesorectal excision |
| HDRBET26 Gy in 4 fractions Administered over Days 1-4 as per institutional standard | Device | Brachytherapy (HDREBT) followed by nivolumab and total mesorectal excision |
| Total Mesorectal Excision (TME)Targeted to take place 6-8 weeks post completion of HDREBT (maximum 12 weeks) | Procedure or surgery | Brachytherapy (HDREBT) followed by nivolumab and total mesorectal excision |
Primary outcome
Pathologic complete response (pCR)
Time frame: This is assessed at the time of total mesorectal excision surgery, occurring approximately 12 weeks after enrollment.
2 secondary outcomes
Incidence and severity of adverse events, as per CTCAE criteria v6.0
Time frame: From time of first treatment through 90 days following last treatment with nivolumab
Assess feasibility of treatment sequence
Time frame: This is assessed from the time of enrollment until the time of surgery, approximately 12 weeks after enrolment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 17714925Vuong T, Devic S, Podgorsak E. High dose rate endorectal brachytherapy as a neoadjuvant treatment for patients with resectable rectal cancer. Clin Oncol (R Coll Radiol). 2007 Nov;19(9):701-5. doi: 10.1016/j.clon.2007.07.006. Epub 2007 Aug 22.
- Background: PubMed 38964714Lin ZY, Zhang P, Chi P, Xiao Y, Xu XM, Zhang AM, Qiu XF, Wu JX, Yuan Y, Wang ZN, Qu XJ, Li X, Nie X, Yang M, Cai KL, Zhang WK, Huang Y, Sun Z, Hou ZG, Ma C, Cheng FZ, Tao KX, Zhang T. Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial. Ann Oncol. 2024 Oct;35(10):882-891. doi: 10.1016/j.annonc.2024.06.015. Epub 2024 Jul 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, HDRBET and Total Mesorectal Excision (TME) in people with Locally Advanced Rectal Cancer, run by Dr. Te Vuong at 1 site 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 26 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (pCR) (time frame: This is assessed at the time of total mesorectal excision surgery, occurring approximately 12 weeks after enrollment.). 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 NCT07645118, which also lists 2 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 28 Oct 2026.