Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer

Trial Title: Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer

NCT ID: NCT05484024

Condition: Rectal Neoplasms Malignant
Radiotherapy

Conditions: Official terms:
Rectal Neoplasms
Neoplasms
Immune Checkpoint Inhibitors

Conditions: Keywords:
rectal cancer
short-course radiotherapy
total neoadjuvant therapy
PD-1 inhibitor

Study type: Interventional

Study phase: Phase 2/Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Sintilimab
Description: PD-1 inhibitor
Arm group label: iTNT group

Other name: Immune checkpoint inhibitor

Intervention type: Radiation
Intervention name: Short-course radiotherapy
Description: Pelvic radiation
Arm group label: TNT group
Arm group label: iTNT group

Other name: hypofraction

Intervention type: Combination Product
Intervention name: CAPOX/mFOLFOX
Description: chemotherapy regimen
Arm group label: TNT group
Arm group label: iTNT group

Other name: neoadjuvant chemotherapy

Summary: 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.

Criteria for eligibility:
Criteria:
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: - Previous treatment with anti-PD-1/L1 and anti-CTLA-4 or other immune experimental drugs. - Severe autoimmune disease: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis) - Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia. - At risk for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for bowel perforation. - history of other malignancies, excluding curable non-melanotic skin cancer and cervix carcinoma in situ； - Active infection, heart failure, heart attack within 6 months, unstable angina or unstable arrhythmia. - Any condition investigator considered may interfere with the results or place the patient at increased risk of treatment complications, or other uncontrollable disease. - Pregnancy or breast feeding - Immunodeficiency disorders including human immunodeficiency virus (HIV), or history of organ transplantation, allogeneic stem cell transplantation - Active hepatitis B virus (HBV) hepatitis (HBV-DNA ≥ 2000 U/mL), hepatitis C virus (HCV) hepatitis, active tuberculosis infection. - Oncology vaccination history or any vaccination within 4 weeks prior to the start of treatment.(Note: influenza vaccines are mostly inactivated and therefore allowed, intranasal preparations are usually live attenuated vaccines and therefore not allowed) - Concomitant other immune agents, chemotherapeutic agents, other drugs in clinical studies, and long term cortisol application

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

Address:
City: Beijing
Country: China

Facility:
Name: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Address:
City: Shenzhen
Country: China

Start date: August 6, 2022

Completion date: July 31, 2030

Lead sponsor:
Agency: Chinese Academy of Medical Sciences
Agency class: Other

Source: ChineseAMS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05484024