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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX
  • Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX

Treatment groups

84 Participants
are divided into 2 treatment groups

Sponsors and collaborators