Actively Recruiting
Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer
Led by Seventh Medical Center of PLA General Hospital · Updated on 2026-03-10
50
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status between 0 and 2
- Biopsy-proven rectal adenocarcinoma
- Tumor located within 10 cm from the anal verge
- No distant metastasis
- Clinical stage II or III based on MRI (excluding T4b)
- Rectal tumor measuring at least 10 mm on baseline CT or MRI
- Able and willing to follow the study protocol
- Willing to provide blood and tissue samples for research
- No previous anti-tumor treatments such as radiotherapy, chemotherapy, immunotherapy, biological therapy, or herbal therapy
- No history of immune system disorders like systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, or HIV infection
- No significant heart, lung, liver, or kidney dysfunction
- No jaundice or gastrointestinal obstruction
- No acute or ongoing infection
- Adequate blood and biochemical function including neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 100 x 10^9/L, serum creatinine ≤ 1.5 times upper limit of normal, total bilirubin ≤ 1.5 times upper limit of normal, ALT and AST ≤ 2.5 times upper limit of normal
- No social or psychiatric disorders interfering with participation
- Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception until 60 days after last study drug dose
You will not qualify if you...
- History of multiple primary cancers or other malignant tumors besides rectal cancer
- Received any anti-cancer treatment including surgery, chemotherapy, radiotherapy, or systemic therapies within the past 5 years
- History of recent major surgery
- Conditions affecting absorption of capecitabine such as inability to swallow, persistent nausea or vomiting, or chronic diarrhea
- Uncontrolled or severe diseases of any kind
- Known allergy or hypersensitivity to study drug components
- Estimated life expectancy 5 years or less
- Planned or previous organ or bone marrow transplantation
- Use of immunosuppressive therapy or systemic corticosteroids for immunosuppression within 1 month prior to enrollment
- History of central nervous system disorders affecting consent or medication compliance
- Other conditions that could interfere with study results or cause early treatment discontinuation such as alcoholism or drug abuse
- Pregnant or breastfeeding women, or women planning pregnancy during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seventh Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100700
Actively Recruiting
Research Team
J
Junfeng Du, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here