Status and phase
Conditions
Treatments
About
This phase II/III trial studies how well neoadjuvant short-course radiotherapy and chemotherapy with or without PD-1 inhibitors works in treating patients with locally advanced rectal adenocarcinoma. Neoadjuvant short-course radiation therapy followed by two-drug regimen chemotherapy, such as CAPOX, were shown to be non-inferior to standard long-course chemoradiotherapy in our previous STELLAR study. Immune checkpoint inhibitors (ICIs) using monoclonal antibodies, such as PD-1 or PD-L1 inhibitor, show promising efficiency and reliable security in some limited sample prospective or retrospective studies. When treating patients with locally advanced rectal cancer, giving sequential neoadjuvant short-course radiotherapy and chemotherapy with PD-1 inhibitor may work better.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Biopsy proven rectal adenocarcinoma;
Distance between tumour and anal verge≤ 10cm;
Locally advanced tumour;(8th edition AJCC/UICC staging :cT3-T4N0/cT2-4N+,M0) Cancer Staging must be based on pelvic MRI or Endoscopic ultrasound;
Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
Mentally and physically fit for chemotherapy; Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit(UNL) Urea nitrogen levels ≤1.0× upper normal limit(UNL) Alanine aminotransferase(ALT) ≤1.5× upper normal limit(UNL) Aspartate aminotransferase(AST) ≤1.5× upper normal limit(UNL) Alkaline phosphatase(ALP) ≤1.5× upper normal limit(UNL) Total bilirubin(TBIL)
≤1.5× upper normal limit(UNL)
No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis.
No previous pelvic radiation history;
Written informed consent;
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
588 participants in 2 patient groups
Loading...
Central trial contact
Wenjue Zhang; Yuan Tang
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal