Rectal Cancer, AdenocarcinomaPhase 2NCRIT-PM9NCT07458529
Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer
A Phase 2 study testing CRT+PD-1 inhibitor+Probio-M9 in people with Rectal Cancer, Adenocarcinoma and Neoadjuvant Therapy, run by Seventh Medical Center of PLA General Hospital at 1 site in China.
Trial summary
This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Adenocarcinoma, Neoadjuvant Therapy, Immunotherapy
- What is being tested?
- CRT+PD-1 inhibitor+Probio-M9
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 1 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
- ECOG performance status 0-2
- Biopsy-proven rectal adenocarcinoma
- Distal tumor margin within 10 cm of the anal verge
- No distant metastasis
- Clinical stage II or III based on MRI (T4b excluded)
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- Maximum diameter of rectal tumor ≥ 10 mm on baseline CT or MRI (measurable lesion according to RECIST 1.1)
- Willing and able to comply with the study protocol
- Willing to provide blood and tissue specimens for research purposes
- No prior anti-tumor treatment (e.g., radiotherapy, chemotherapy, immunotherapy, biological therapy, or herbal therapy)
- No history of immune system disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, HIV infection, etc.)
- No significant dysfunction of major organs (heart, lung, liver, kidney)
- No jaundice or gastrointestinal obstruction
- No acute or ongoing infection
- Adequate hematologic and biochemical function including:
- Neutrophils ≥ 1.5 × 10^9/L
- Hemoglobin ≥ 80 g/L
- Platelets ≥ 100 × 10^9/L
- Serum creatinine ≤ 1.5 × ULN
- Total bilirubin ≤ 1.5 × ULN
- ALT and AST ≤ 2.5 × ULN
- No social or psychiatric disorders that may interfere with study participation
- Women of childbearing potential must have a negative pregnancy test before enrollment and must use effective contraception from study entry until 60 days after the last dose of study drug
Who cannot join
- History of multiple primary cancers or concomitant malignant tumors other than rectal cancer
- Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years
- History of recent major surgery
- Conditions that may affect the gastrointestinal absorption of capecitabine (e.g., inability to swallow, persistent nausea or vomiting, chronic diarrhea)
- Uncontrolled or severe concomitant diseases of any kind
- Known allergy or hypersensitivity to any components of the study drugs
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- Estimated life expectancy ≤ 5 years due to any cause
- Planned or prior organ or bone marrow transplantation
- Use of immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment
- History of central nervous system disorders that may impair the ability to provide informed consent or affect compliance with oral medication (investigator discretion)
- Other conditions that may interfere with study results or lead to premature discontinuation of study treatment (e.g., alcoholism or drug abuse)
- Pregnant or breastfeeding women, or women planning to become pregnant during the treatment period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Seventh Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100700
Junfeng Du, PhD, +86 15810908850, dujunfeng@301hospital.com.cn
About this study
Official title: Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)
This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).
Read the detailed description
Patients with clinically staged II-III pMMR/MSS locally advanced rectal adenocarcinoma (≤10 cm from anal verge) will receive long-course chemoradiotherapy (50 Gy/25 fractions) with concurrent Capecitabine, followed by two cycles of CapeOX chemotherapy and Tislelizumab (200 mg IV every 3 weeks). Participants will be randomized to receive either daily oral Probio-M9 (2 g) or matched placebo from treatment initiation until surgery.
- Conditions
- Rectal Cancer, Adenocarcinoma, Neoadjuvant Therapy, Immunotherapy, Probio-M9, Tislelizumab, Randomized
- Being tested
- CRT+PD-1 inhibitor+Probio-M9, CRT+PD-1 inhibitor+placebo
- Keywords
- Probio-M9, tislelizumab, locally advanced rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT+PD-1 inhibitor+Probio-M9Combination product
Chemoradiation with PD-1 inhibitor (tislelizumab), with or without Probio-M9. Probio-M9 is administered orally at a dose of 2 g (one sachet) once daily. Treatment begins at the initiation of neoadjuvant chemoradiotherapy and continues until the day before surgical resection.
CRT+PD-1 inhibitor+placeboCombination product
Chemoradiation with PD-1 inhibitor (tislelizumab) with placebo. Placebo is administered orally at a dose of 2 g (one sachet) once daily. Treatment begins at the initiation of neoadjuvant chemoradiotherapy and continues until the day before surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| CRT+PD-1 inhibitor+Probio-M9 | Experimental | Not described Receives: Combination Product: CRT+PD-1 inhibitor+Probio-M9 |
| CRT+PD-1 inhibitor+placebo | Placebo comparator | Not described Receives: Combination Product: CRT+PD-1 inhibitor+placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pathological complete response rate
Measured: within 10 days after surgery
Secondary outcomes (8)
2-y OS rate
2-year overall survival rate
Measured: 2 year
2-y DFS rate
2-year disease free survival rate
Measured: 2 year
3-y OS rate
3-year overall survival rate
Measured: 3 year
3-y DFS rate
3-year disease free survival rate
Measured: 3 year
5-y OS rate
5-year overall survival rate
Measured: 5 year
5-y DFS rate
5-year disease free survival rate
Measured: 5 year
immune-related adverse event rate
adverse event rate that is deemed to be associated with PD-1 inhibition
Measured: from commencing of PD-1 inhibition to the 30th day after surgery
Changes in Gut Microbiota Composition
Gut microbiota composition will be analyzed using metagenomic sequencing of stool samples. Fecal samples will be collected to evaluate microbial diversity, relative abundance of bacterial taxa, and functional pathway alterations during neoadjuvant treatment.
Measured: Stool samples will be collected at baseline (Day 1), Day 25 during treatment, and prior to surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start10 Feb 2026
- Primary completion5 May 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer, AdenocarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seventh Medical Center of PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458529
- Sponsor's protocol ID
- S2026-010
- Acronym
- NCRIT-PM9
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Export of individual patient data is a sensitive issue according to current Chinese laws
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)
- ClinicalTrials.gov ID
- NCT07458529
- Acronym / sponsor ID
- NCRIT-PM9 / S2026-010
- Conditions
- Rectal Cancer, Adenocarcinoma, Neoadjuvant Therapy, Immunotherapy, Probio-M9, Tislelizumab, Randomized
- Keywords
- Probio-M9, tislelizumab, locally advanced rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seventh Medical Center of PLA General HospitalUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 9 Mar 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 prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).
Detailed description
Patients with clinically staged II-III pMMR/MSS locally advanced rectal adenocarcinoma (≤10 cm from anal verge) will receive long-course chemoradiotherapy (50 Gy/25 fractions) with concurrent Capecitabine, followed by two cycles of CapeOX chemotherapy and Tislelizumab (200 mg IV every 3 weeks). Participants will be randomized to receive either daily oral Probio-M9 (2 g) or matched placebo from treatment initiation until surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT+PD-1 inhibitor+Probio-M9 | Experimental | Combination Product: CRT+PD-1 inhibitor+Probio-M9 |
| CRT+PD-1 inhibitor+placebo | Placebo comparator | Combination Product: CRT+PD-1 inhibitor+placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥ 18 years
- ECOG performance status 0-2
- Biopsy-proven rectal adenocarcinoma
- Distal tumor margin within 10 cm of the anal verge
- No distant metastasis
Key exclusion criteria (12 listed)
- History of multiple primary cancers or concomitant malignant tumors other than rectal cancer
- Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years
- History of recent major surgery
- Conditions that may affect the gastrointestinal absorption of capecitabine (e.g., inability to swallow, persistent nausea or vomiting, chronic diarrhea)
- Uncontrolled or severe concomitant diseases of any kind
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 |
|---|---|---|
| CRT+PD-1 inhibitor+Probio-M9Chemoradiation with PD-1 inhibitor (tislelizumab), with or without Probio-M9. Probio-M9 is administered orally at a dose of 2 g (one sachet) once daily. Treatment begins at the initiation of neoadjuvant chemoradiotherapy and continues until the day before surgical resection. | Combination product | CRT+PD-1 inhibitor+Probio-M9 |
| CRT+PD-1 inhibitor+placeboChemoradiation with PD-1 inhibitor (tislelizumab) with placebo. Placebo is administered orally at a dose of 2 g (one sachet) once daily. Treatment begins at the initiation of neoadjuvant chemoradiotherapy and continues until the day before surgical resection. | Combination product | CRT+PD-1 inhibitor+placebo |
Primary outcome
pCR rate
Time frame: within 10 days after surgery
pathological complete response rate
8 secondary outcomes
2-y OS rate
Time frame: 2 year
2-y DFS rate
Time frame: 2 year
3-y OS rate
Time frame: 3 year
3-y DFS rate
Time frame: 3 year
5-y OS rate
Time frame: 5 year
5-y DFS rate
Time frame: 5 year
immune-related adverse event rate
Time frame: from commencing of PD-1 inhibition to the 30th day after surgery
Changes in Gut Microbiota Composition
Time frame: Stool samples will be collected at baseline (Day 1), Day 25 during treatment, and prior to surgery.
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 10 Mar 2026.
- Individual participant dataSharing planned: No. Export of individual patient data is a sensitive issue according to current Chinese laws
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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 CRT+PD-1 inhibitor+Probio-M9 in people with Rectal Cancer, Adenocarcinoma and Neoadjuvant Therapy, run by Seventh Medical Center of PLA General Hospital at 1 site in China.
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 23 inclusion and 12 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 10 Mar 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 China. 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?
Contact Junfeng Du, PhD (+86-15810908850, dujunfeng@301hospital.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: within 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.