BridgeMD
New treatment option for Rectal Cancer
Official title Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I)
ClinicalTrials.gov ID: NCT06923345
What this study is testing
What is Reduced CTV?
Reduced CTV is an investigational medicine, being studied as a potential treatment for rectal cancer.
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
- The goal of this clinical trial is to evaluate whether a total neoadjuvant therapy (TNT) regimen combining long-course chemoradiotherapy, sequential chemotherapy, and PD-1 inhibitor can improve response rates, enhance tolerability, and improve prognosis in patients with locally advanced, microsatellite-stable (MSS) rectal cancer. The main questions it aims to answer are: Does this TNT approach improve complete response (CR) rates?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily signs a written informed consent form.
- Aged between 18 and 75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival of more than 2 years.
- Histologically confirmed rectal adenocarcinoma.
You likely can't join if
- Presence of suspected metastatic lesions or locally advanced unresectable disease, regardless of disease stage.
- Diagnosis of other malignancies within the past five years, except for patients with malignancies cured through local treatment (e.g., basal or...
- Concurrent enrollment in another clinical study, unless it is an observational, non-treatment study or a follow-up phase of an treatment study.
- Presence of intestinal obstruction, perforation, or bleeding requiring emergency surgery.
- Multiple primary rectal cancers.
- History of pelvic or abdominal radiotherapy.
See the full eligibility criteria
Who can join
- Voluntarily signs a written informed consent form.
- Aged between 18 and 75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival of more than 2 years.
- Histologically confirmed rectal adenocarcinoma.
- Tumor biopsy immunohistochemistry indicating pMMR (MSH1, MSH2, MSH6, and PMS2 all positive) or genetic testing confirming MSS.
- According to the 8th edition of the AJCC TNM classification, high-resolution MRI ± endorectal ultrasound confirms clinical staging as cT3-4NanyM0 or cTxN+M0 (stage II-III rectal cancer). MRI confirms the tumor is...
- Before study enrollment, a responsible surgical attending physician must evaluate the patient's medical history to confirm eligibility for R0 resection with curative intent.
- No prior systemic or local anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy.
- Willing to provide tumor tissue and peripheral blood samples for research purposes during screening and throughout the study.
- Adequate organ function:
- Hematology (without recent blood transfusions or growth factor support within 7 days before treatment):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (1,500/mm³)
- Platelet count ≥ 100 × 10⁹/L (100,000/mm³)
- Hemoglobin ≥ 90 g/L
- Renal function:
- Estimated creatinine clearance (CrCl) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
- Urine protein \< 2+ or 24-hour urine protein quantification \< 1.0 g
- Liver function:
- Total bilirubin (TBil) ≤ 1.5 × upper limit of normal (ULN)
- AST and ALT ≤ 2.5 × ULN
- Serum albumin (ALB) ≥ 28 g/L
- Coagulation function: o INR and APTT ≤ 1.5 × ULN
- Cardiac function: o Left ventricular ejection fraction (LVEF) ≥ 50%
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 3 days before starting study treatment. If a urine pregnancy test result is unclear, a confirmatory serum pregnancy...
- Definition of females of childbearing potential (FCBP): Women who have not undergone surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or who have not been naturally...
- Highly effective contraception methods: Must have a failure rate of \<1% per year when used consistently and correctly. In addition to barrier methods, FCBP must use an additional hormonal contraceptive method (e.g...
- Participants must be willing and able to comply with study visit schedules, treatment plans, laboratory tests, and other study-related requirements.
What rules you out
- Presence of suspected metastatic lesions or locally advanced unresectable disease, regardless of disease stage.
- Diagnosis of other malignancies within the past five years, except for patients with malignancies cured through local treatment (e.g., basal or squamous cell skin cancer, superficial bladder cancer, ductal carcinoma in...
- Concurrent enrollment in another clinical study, unless it is an observational, non-treatment study or a follow-up phase of an treatment study.
- Presence of intestinal obstruction, perforation, or bleeding requiring emergency surgery.
- Multiple primary rectal cancers.
- History of pelvic or abdominal radiotherapy.
- Inability to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption.
- Prior systemic or local anti-tumor treatment for locally advanced rectal cancer, including radical surgery, chemotherapy, radiotherapy, immunotherapy (e.g., immune checkpoint inhibitors, immune cell therapy), biological...
- Use of nonspecific immunomodulatory treatment (e.g., interleukins, interferons, thymosin, TNF) within two weeks before study treatment (excluding IL-11 for thrombocytopenia); use of traditional Chinese medicine with...
- Active autoimmune disease requiring systemic treatment in the past two years, except for replacement therapy (e.g., thyroid hormone, insulin, corticosteroids for adrenal/pituitary insufficiency).
- History of non-infectious pneumonitis requiring systemic glucocorticoid therapy or interstitial lung disease.
- History of severe bleeding tendency, coagulopathy, or long-term anticoagulation therapy (e.g., atrial fibrillation with CHADS2 score ≥2).
- Uncontrolled comorbidities, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease, or psychiatric/social conditions limiting...
- History of myocarditis, cardiomyopathy, malignant arrhythmias; hospitalization for unstable angina, congestive heart failure, or vascular diseases (e.g., aortic aneurysm requiring surgery) within 12 months before study...
- History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea).
- Severe infection within four weeks before study treatment, including sepsis or severe pneumonia requiring hospitalization; active infection requiring systemic therapy within ten days before study treatment (excluding...
- Major surgery or severe trauma within 30 days before study treatment; minor surgery (excluding peripheral venous catheterization) within three days before study treatment.
- Immunodeficiency history, positive HIV test, or long-term use of systemic corticosteroids or immunosuppressants.
- Active tuberculosis or suspected TB requiring clinical exclusion; known active syphilis infection.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Untreated active HBV infection (HBsAg-positive with HBV-DNA \> 1000 copies/ml or 200 IU/ml); active HCV infection (HCV antibody-positive with detectable HCV-RNA).
- Live vaccine administration within 30 days before study treatment or planned during the study period.
- Known hypersensitivity to any study drug component or history of severe hypersensitivity reactions to monoclonal antibodies.
- History of psychiatric disorders, substance abuse, alcohol dependence, or drug addiction.
- Pregnant or breastfeeding women.
- Any disease, treatment, or laboratory abnormality that may confound study results, interfere with full study participation, or is not in the participant's best interest.
- Non-malignant or tumor-related systemic diseases or symptoms causing high medical risk or uncertainty in survival assessment.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.