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New treatment option for Rectal Cancer
Official title Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II)
ClinicalTrials.gov ID: NCT06958432
What this study is testing
What is Node-Sparing Radiotherapy plus Chemotherapy and PD-1 inhibitor?
Node-Sparing Radiotherapy plus Chemotherapy and PD-1 inhibitor 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
- Most rectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) and respond poorly to PD-1 inhibitors. Radiotherapy can enhance tumor antigen release and improve responsiveness to PD-1 blockade in MSS/pMMR rectal cancer.
- Phase 3: a large, late-stage study
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 the time of 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 unresectable locally advanced disease, regardless of clinical stage.
- History of any other malignancy within 5 years prior to enrollment, excluding those considered cured by local therapy (e.g., basal cell carcinoma...
- Lesions initially staged as T1N0 eligible for local excision, or T2N0 suitable for sphincter-preserving surgery after multidisciplinary discussion.
- Evidence of acute conditions requiring emergency surgery, such as bowel obstruction, perforation, or gastrointestinal bleeding.
- Synchronous 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 the time of 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 indicates proficient mismatch repair (pMMR), defined by positive immunohistochemical staining for MSH1, MSH2, MSH6, and PMS2, or molecular testing confirms microsatellite stability (MSS).
- Clinical stage T3-4N0M0 or TanyN+M0 based on the 8th edition of the AJCC TNM classification, as evaluated by high-resolution MRI ± endoscopic ultrasound/transrectal ultrasonography, with the tumor located in the...
- Prior to enrollment, a qualified surgical attending physician must assess the patient's medical history and confirm eligibility for curative R0 resection.
- No prior systemic or local anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy.
- Agrees to provide tumor tissue and peripheral blood samples during screening and throughout the study for research purposes.
- Adequate organ function, defined as follows:
- Hematologic (without use of blood components or growth factors within 7 days prior to treatment initiation):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Platelet count ≥ 100 × 10⁹/L
- Hemoglobin ≥ 90 g/L
- Renal:
- Calculated creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula: CrCl (mL/min) = [(140 - age) × weight (kg) × 0.85 (if female)] / (72 × serum creatinine [mg/dL])
- Urine protein \< 2+ on dipstick or \< 1.0 g per 24-hour collection
- Hepatic:
- Total bilirubin ≤ 1.5 × ULN
- AST and ALT ≤ 2.5 × ULN
- Serum albumin ≥ 28 g/L
- Coagulation:
- INR and APTT ≤ 1.5 × ULN
- Cardiac:
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to initiating study treatment. If the urine test is inconclusive, a serum test must confirm the negative result...
- Women of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) and have not undergone menopause (defined as ≥12 months of...
- Highly effective contraception methods are those with \<1% failure rate per year when used consistently and correctly (e.g., hormonal contraceptives). In addition to barrier methods, hormonal contraception is required...
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.
What rules you out
- Presence of suspected metastatic lesions or unresectable locally advanced disease, regardless of clinical stage.
- History of any other malignancy within 5 years prior to enrollment, excluding those considered cured by local therapy (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, or...
- Lesions initially staged as T1N0 eligible for local excision, or T2N0 suitable for sphincter-preserving surgery after multidisciplinary discussion.
- Evidence of acute conditions requiring emergency surgery, such as bowel obstruction, perforation, or gastrointestinal bleeding.
- Synchronous 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 therapy for locally advanced rectal cancer, including curative surgery, chemotherapy, radiotherapy, immunotherapy (e.g., immune checkpoint inhibitors, agonists, or cell-based...
- Use of nonspecific immunomodulatory treatments (e.g., interleukins, interferons, thymic peptides, tumor necrosis factor) within 2 weeks prior to study treatment (excluding IL-11 for thrombocytopenia), or use of herbal...
- Active autoimmune disease requiring systemic treatment (e.g., with disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapies (e.g., thyroid hormone, insulin, or...
- History of or current interstitial lung disease or non-infectious pneumonitis requiring systemic corticosteroid treatment.
- History of bleeding disorders or coagulopathy; patients requiring long-term anticoagulation (e.g., atrial fibrillation with CHADS2 score ≥ 2).
- Uncontrolled comorbidities, including but not limited to: decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe peptic ulcer or gastritis, or psychiatric/social conditions affecting...
- History of myocarditis, cardiomyopathy, or malignant arrhythmias; unstable angina, heart failure requiring hospitalization, or vascular disease (e.g., aortic aneurysm requiring repair or deep vein thrombosis) within 12...
- Within 6 months prior to treatment: history of gastroesophageal varices, severe ulcers, non-healed wounds, gastrointestinal perforation, fistulas, bowel obstruction, intra-abdominal abscess, or acute GI bleeding.
- Arterial thromboembolism, grade ≥3 venous thromboembolism (per NCI-CTCAE v5.0), transient ischemic attack, stroke, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to study treatment.
- Acute exacerbation of COPD within 1 month prior to treatment; current hypertension not controlled to \<160/100 mmHg despite antihypertensive medication.
- Active or prior inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or chronic diarrhea.
- Severe infections within 4 weeks prior to treatment, including complications requiring hospitalization, sepsis, or severe pneumonia; active infections requiring systemic anti-infective therapy within 10 days prior to...
- Major surgery or serious trauma within 30 days prior to treatment; minor local surgery within 3 days (excluding PICC placement).
- History of immunodeficiency or HIV antibody positivity; long-term systemic corticosteroid or immunosuppressive therapy.
- Active tuberculosis or suspected TB not ruled out via clinical assessment (e.g., sputum test, chest X-ray); known active syphilis.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Untreated active hepatitis B (HBsAg-positive with HBV DNA \> 1,000 copies/mL or 200 IU/mL); active hepatitis C (HCV antibody-positive with detectable HCV RNA).
- Receipt of a live vaccine within 30 days prior to treatment or planned live vaccination during the study.
- Known hypersensitivity to any component of the investigational drugs, or history of serious hypersensitivity reactions to monoclonal antibodies.
- Known history of psychiatric disorders, substance abuse, alcoholism, or drug addiction.
- Pregnant or breastfeeding women.
- Any disease, treatment, or abnormal laboratory finding that may interfere with study results, affect full study participation, or is not in the patient's best interest.
- Systemic or local disease caused by a benign tumor, or tumor-related complications/symptoms that pose high medical risk or survival uncertainty (e.g., leukemoid reaction with WBC \> 20 × 10⁹/L, cachexia with \>10%...
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.