Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer

NCT07458529 | Recruiting Phase 2 DMC

• 1 other identifier: S2026-010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Rectal Cancer, Adenocarcinoma; Neoadjuvant Therapy; Immunotherapy; Probio-M9; Tislelizumab; Randomized

Keywords

Probio-M9; tislelizumab; locally advanced rectal cancer

Outcome Measures

Primary Outcomes (1)

• pCR rate

  pathological complete response rate

  within 10 days after surgery

Secondary Outcomes (8)

• 2-y OS rate

  2 year

• 2-y DFS rate

  2 year

• 3-y OS rate

  3 year

• 3-y DFS rate

  3 year

• 5-y OS rate

  5 year

Study Arms (2)

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

Interventions

CRT+PD-1 inhibitor+Probio-M9 COMBINATION_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+Probio-M9

CRT+PD-1 inhibitor+placebo COMBINATION_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.

CRT+PD-1 inhibitor+placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Seventh Medical Center of PLA General Hospital: lead

Study Sites (1)

Seventh Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Junfeng Du, PhD

CONTACT

+86-15810908850; dujunfeng@301hospital.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)