NCT07622771RecruitingPhase 2
Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial
Sun Yat-sen University2 sites in 1 country84 target enrollmentStarted: May 26, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 2
Study Overview
Brief Summary
To explore the efficacy and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients or their family members agree to participate in the study and sign the informed consent form;
- •Age 18-75 years, male or female;
- •Locally advanced rectal adenocarcinoma confirmed by histopathology;
- •Clinical stage cT3-4bN0M0 or cTxN+M0, with or without MRF positive, with or without EMVI positive, expected to R0 resection;
- •without intestinal obstruction;
- •ECOG PS 0-1;
- •expect survival up to 2 years;
- •White blood cell count > 3.5×109/L；Platelet count ≥ 100×109/L；Hemoglobin ≥ 80 g/L；
- •ALT ≤ 1.5×ULN, AST ≤ 1.5×ULN ；
- •Serum creatinine ≤ 100μmol/l,
Exclusion Criteria
- •With inguinal lymph node metastasis or lateral lymph node metastasis (lymph node diameter ≥7 mm, or lymph node morphology and MRI features consistent with typical metastatic lymph nodes);
- •Arrhythmia requiring antiarrhythmic treatment (except beta-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure exceeding NYHA Class II;
- •Severe hypertension poorly controlled with medication;
- •History of HIV infection, or active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay);
- •Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening;
- •Other active clinically severe infections (NCI-CTCAE Version 5.0);
- •Preoperative evidence of distant metastasis outside the pelvis;
- •Cachexia or organ function decompensation.
- •History of pelvic or abdominal radiotherapy;
- •Multiple primary colorectal cancers;
- •Patients with seizures requiring treatment (e.g., corticosteroids or antiepileptic therapy);
- •History of other malignancies within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;
- •Drug abuse, or medical, psychological, or social conditions that may interfere with the patient's participation in the study or affect the evaluation of study results;
- •Active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enterocolitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism);
- •Receipt of any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment;
- •Comorbidities requiring long-term treatment with immunosuppressive agents, or requiring systemic or local administration of corticosteroids at immunosuppressive doses (dose >10 mg/day of prednisone or other glucocorticoids with equivalent efficacy);
- •Known or suspected hypersensitivity to the investigational drug, or to any medication administered in relation to this study;
- •Any unstable condition that may jeopardize patient safety or compliance;
- •Pregnant or lactating women, or women of childbearing potential not using adequate contraception;
- •Refusal to sign the informed consent form.
Arms & Interventions
LCRT combined with Adalimumab and NALIRIFOX
Experimental
Adalimumab combined with NALIRIFOX for two cycles. Radiotherapy: Long-course chemoradiotherapy (LCRT) (50Gy/25F, during the same period, capecitabine was 825 mg/m2, twice a day, 5 days a week). Consolidation: Adalimumab combined with NALIRIFOX for six cycles
Intervention: Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX (Combination Product)
SCRT combined with Adalimumab and NALIRIFOX
Experimental
Adalimumab combined with NALIRIFOX for two cycles. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: Adalimumab combined with NALIRIFOX for six cycles
Intervention: Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX (Combination Product)
Investigators
ZHI-ZHONG PAN
Professor
Sun Yat-sen University
Study Sites (2)
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