Phase 2: Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX for Rectal Cancers
To explore the how well it works and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer
Official registry: https://clinicaltrials.gov/study/NCT07622771 · Sun Yat-sen University · enrollment listed as 84
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX, or Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX. The registry lists allocation as randomized. To explore the how well it works and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer
They plan to enroll about 84 people at Guangzhou. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial
Interventions: Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX, Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX
Primary outcome (registry wording): CR rate
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- 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;
- 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 ；
Who the registry excludes
- 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;
Public study contact (from the registry)
Chi Zhou
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, P. R. China — Guangzhou, Guangdong, China (recruiting)
FAQ about this NCT record
Is NCT07622771 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07622771?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07622771?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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