Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial

NCT07622771 | Not Yet Recruiting Phase 2

• 1 other identifier: B2026-229-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficacy and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer

Conditions

Rectal Cancers

Keywords

radiotherapy; immunotherapy; neoadjuvant therapy; rectal cancer

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• Event-Free Survival(EFS) rate

  an expected average of 5 years

• R0 resection rate

  an expected average of 2 years

• ORR[Objective Response Rate]

  an expected average of 1.5 years

• OPR

  an expected average of 1.5 years

• Overall Survival

  an expected average of 5 years

Study Arms (2)

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

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;

SCRT combined with Adalimumab and NALIRIFOX

Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX COMBINATION_PRODUCT

Long course chemoradiotherapy,50 Gy in 25 fractions, during the same period, capecitabine was 825 mg / m2, twice a day, 5 days a week; 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;

LCRT combined with Adalimumab and NALIRIFOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Chi Zhou

CONTACT

+86 20 87343920; 447486353@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From Study complement

Locations

CN (1)