BridgeMD
New treatment option for Rectal Cancer, Adenocarcinoma
Official title Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT07458529
What this study is testing
What is CRT+PD-1 inhibitor+Probio-M9?
CRT+PD-1 inhibitor+Probio-M9 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for rectal cancer, adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- Uncontrolled or severe concomitant diseases of any kind
- Known allergy or hypersensitivity to any components of the study drugs
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.