Trial Radar AI | ||
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Clinical Trial NCT07458529 (NCRIT-PM9) for Rectal Cancer, Adenocarcinoma, Neoadjuvant Therapy, Immunotherapy, Probio-M9, Tislelizumab, Randomized is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer (NCRIT-PM9) Phase 2 50 Randomized
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)
- NCRIT-PM9
- S2026-010
tislelizumab
locally advanced rectal cancer
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCRT+PD-1 inhibitor+Probio-M9 | CRT+PD-1 inhibitor+Probio-M9 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. |
Placebo ComparatorCRT+PD-1 inhibitor+placebo | CRT+PD-1 inhibitor+placebo 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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
pCR rate | pathological complete response rate | within 10 days after surgery |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
2-y OS rate | 2-year overall survival rate | 2 year |
2-y DFS rate | 2-year disease free survival rate | 2 year |
3-y OS rate | 3-year overall survival rate | 3 year |
3-y DFS rate | 3-year disease free survival rate | 3 year |
5-y OS rate | 5-year overall survival rate | 5 year |
5-y DFS rate | 5-year disease free survival rate | 5 year |
immune-related adverse event rate | adverse event rate that is deemed to be associated with PD-1 inhibition | 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. | Stool samples will be collected at baseline (Day 1), Day 25 during treatment, and prior to surgery. |
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)
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
- 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
- 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
Seventh Medical Center of PLA General HospitalBeijing Municipality