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NCT05484024

PHASE2/PHASE3

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

Sponsor: Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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.

Official title: Preoperative Short-course Radiotherapy Followed by Chemotherapy With or Without PD-1 Inhibitor for Locally Advanced Rectal Cancer: a Prospective, Multicenter, Randomized Controlled, Phase II/III Study (STELLAR II Study)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

588

Start Date

2022-08-06

Completion Date

2030-07-31

Last Updated

2022-08-02

Healthy Volunteers

Conditions

Rectal Neoplasms Malignant Radiotherapy

Interventions

DRUG

Sintilimab

PD-1 inhibitor

RADIATION

Short-course radiotherapy

Pelvic radiation

COMBINATION_PRODUCT

CAPOX/mFOLFOX

chemotherapy regimen

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

Locations (2)

Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

Beijing, Beijing Municipality, China

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

Shenzhen, China