Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adeb... | NCT07622771

NCT07622771

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Combination Product: Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX
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	Combination Product: Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX	Combination Product	Short course radiotherapy, 5 * 5Gy, once a day, 5Gy each time, for 5 days; Adalimumab 1200 mg , D1, q2w, 2 cycles before radiotherapy and 6 cycles after radiotherapy; NALIRIFOX: Oxaliplatin 85 mg/m2, D1; Liposomal irinotecan 60 mg/m2, D1; LV 200 mg/m2; 5-FU 2400 mg/m2, Infusion for 48 hours; Repeat every 2 weeks. 2 cycles before radiotherapy and 6 cycles after radiotherapy;

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CR rate	the number of patients with a pCR for those who underwent surgery and a cCR for those who underwent WW; The pCR was defined as the absence of any tumor cells from the primary tumor and lymph nodes in the specimen after radical surgery (ypT0N0) or the absence of any tumor cells in the lesion after local resection (ypT0).The cCR was defined as the absence of residual disease on DRE, MRI, and endoscopy.	up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Event-Free Survival(EFS) rate	The percentage of patients without disease recurrence or progression or death due to any cause	an expected average of 5 years
R0 resection rate	The rate of negative margin microscopically

Eligibility Module

Eligibility Criteria

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.

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases