rectal cancer
Conditions
Interventions
Cadonilimab with Radiochemotherapy group:Short-Course Preoperative Radiotherapy plus Cadonilimab with Chemotherapy
Sponsors
First Affiliated hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)Age from 18 to 70; (2)Eastern Cooperative Oncology Group (ECOG) score: 0-1 or Karnofsky score= 80; (3)Pathological diagnosed as rectal adenocarcinoma by colonoscopy biopsy; (4)The participants agree to provide enough tumor tissue samples from colonoscopy biopsy for MSI, TMB and other tests; (5)Imaging test show that the tumor was located below peritoneal reflexion; (6)T3-4 with or without lymph node metastasis through MRI (2018 AJCC 8th); (7)No distant metastasis through chest and abdomen enhanced CT; (8)There are no contraindications of chemoradiotherapy and immunotherapy; (9)Participants are required to be informed of this study before the trial, and voluntarily sign a written informed consent, willing and able to receive follow-up visit, treatment plans, laboratory tests, and other study procedures; (10)Women with childbearing age must have a negative serum pregnancy test within 7 days before randomization and agree to use a reliable and effective method of contraception during the trial period and for 5 months after the last dose. For male participants whose partner is a woman of reproductive age, must also agree to conduct a reliable and effective method of contraception during the trial period and for 5 months after the last dose. Lactating women could not be enrolled.
Exclusion criteria
Exclusion criteria: (1)Receive chemotherapy, surgery, or other antitumor therapy priorly; (2)The site of the proposed radiotherapy had previously received radiation therapy (3)Patients with malignancies other than rectal cancer (except cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer with radical treatment, and ductal carcinoma in situ with radical treatment, etc.) in the 5 years prior to admission; (4)Have an active autoimmune disease that requires systemic treatment (i.e. immunomodulatory drugs, corticosteroids, or immunosuppressive drugs) within the last 2 years; However, replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) will not be considered systemic therapy and will be permitted; (5)Have an immune deficiency or are receiving long-term systemic steroid therapy (more than 10 mg daily dose of prednisone or other effective glucocorticoids) or other immunosuppressive therapy within 7 days prior to enrollment;; (6)Uncontrolled diabetes; (7)Prior to randomization, there was an active infection (other than viral hepatitis) requiring systemic treatment (oral or intravenous); (8)Peripheral neuropathy = grade 2; (9)Patients with active TB or who had received anti-TB therapy within 1 year prior to randomization; (10)If Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) are positive, HBV-DNA must be less than 500IU/mL; For patients with active hepatitis B, patients were required to have received antiviral therapy for at least 14 days prior to randomization (local standard therapy, such as Entecavir or tenofovir) and to agree to continue receiving effective antiviral therapy during the study period; (11)If HCV antibody is positive, HCV-RNA test is performed, and HCV-RNA>1000 copy number /mL should be excluded; (12)Human immunodeficiency virus (HIV) antibody positive. (13)Receive any live vaccines within 28 days prior to enrollment (for example, vaccines against infectious diseases, such as influenza vaccines, chickenpox vaccines, etc); (14)previously received a bone marrow allograft or solid organ transplant; (15)A history of severe allergy to monoclonal antibodies or other biologic agents; (16)Join in other interventional clinical studies were conducted within 28 days prior to enrollment; (17)The investigators determined the presence of medical conditions that could affect study drug administration or protocol adherence; (18)Other unsuitable participants determined by the researchers.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;1 year diseases-free survival rate;3 year diseases-free survival rate;1 year overall survival rate;3 year overall survival rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Countries
China
Contacts
Public ContactChen Chuangqi
Gastrointestinal surgery department from First Affiliated hospital of Sun Yat-Sen University
Outcome results
None listed