Neoadjuvant radiotherapy with NALIRIFOX and Adebrelimab in locally advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II randomized interventional trial evaluating a neoadjuvant treatment strategy for locally advanced rectal adenocarcinoma. Participants receive Adalimumab (note: based on provided text, Adalimumab appears as part of the regimen) plus NALIRIFOX, followed by a short course of radiotherapy, then Adalimumab plus NALIRIFOX again, and finally a longer course of chemoradiotherapy. The study aims to assess safety and preliminary efficacy in patients with pMMR/MSS tumors eligible for potential R0 resection. Eligibility includes adults 18-75 with CLINICAL stage cT3-4bN0M0 or cTxN+M0, ECOG 0-1, adequate organ function, and no significant comorbidities that would preclude surgery. The trial is conducted at Sun Yat-sen University Cancer Center in Guangzhou, China, and is sponsored by Sun Yat-sen University.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients or their family members agree to participate in the study and sign the informed consent form;
2. Age 18-75 years, male or female;
3. Locally advanced rectal adenocarcinoma confirmed by histopathology;
4. Clinical stage cT3-4bN0M0 or cTxN+M0, with or without MRF positive, with or without EMVI positive, expected to R0 resection;
5. without intestinal obstruction;
6. ECOG PS 0-1;
7. expect survival up to 2 years;
8. White blood cell count \> 3.5×109/L；Platelet count ≥ 100×109/L；Hemoglobin ≥ 80 g/L；
9. ALT ≤ 1.5×ULN, AST ≤ 1.5×ULN ；
10. Serum creatinine ≤ 100μmol/l,

Exclusion Criteria:

1. 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);
2. 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;
3. Severe hypertension poorly controlled with medication;
4. 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);
5. Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening;
6. Other active clinically severe infections (NCI-CTCAE Version 5.0);
7. Preoperative evidence of distant metastasis outside the pelvis;
8. Cachexia or organ function decompensation.
9. History of pelvic or abdominal radiotherapy;
10. Multiple primary colorectal cancers;
11. Patients with seizures requiring treatment (e.g., corticosteroids or antiepileptic therapy);
12. History of other malignancies within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;
13. 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;
14. Active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enterocolitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism);
15. Receipt of any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment;
16. 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);
17. Known or suspected hypersensitivity to the investigational drug, or to any medication administered in relation to this study;
18. Any unstable condition that may jeopardize patient safety or compliance;
19. Pregnant or lactating women, or women of childbearing potential not using adequate contraception;
20. Refusal to sign the informed consent form.

Where it's running

• Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, P. R. China
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Chi Zhou
• Email: 447486353@qq.com
• Phone: +86 20 87343920

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.