NCT07458529 Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer
| NCT ID | NCT07458529 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Seventh Medical Center of PLA General Hospital |
| Condition | Rectal Cancer, Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2027-05-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-02-10 with a primary completion date of 2027-05-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07458529 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer, Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07458529 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07458529 currently recruiting?
Yes, NCT07458529 is actively recruiting participants. Contact the research team at dujunfeng@301hospital.com.cn for enrollment information.
Where is the NCT07458529 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07458529 clinical trial?
NCT07458529 is sponsored by Seventh Medical Center of PLA General Hospital. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.