About this trial
The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC.
Participants will take:
Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1: Sign the informed consent form and voluntarily participate in this study
Disqualifiers
Allergy to monoclonal antibody, SHR-1701, capecitabine, oxaliplatin and other platinum drugs
The patient previously received or is receiving any following treatments: a) Any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; b) Within 2 weeks before the first use of the study drug, is using immunosuppressive drugs or systemic hormone drugs to achieve immunosuppression (dose > 10mg/day prednisone or equivalent); in the absence of active autoimmune diseases, inhalation or local use of steroids and doses > 10mg/day prednisone or equivalent adrenal cortical hormones are allowed; c) Has received attenuated live vaccines within 4 weeks before the first use of the study drug; d) Has undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the study drug.
Having any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergy that has completely resolved and does not require any intervention after adulthood can be considered for inclusion, but patients who require medical intervention with bronchodilators cannot be included.
Have a history of immunodeficiency, including a positive HIV test result, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation.
Trial design
Single group
Treatments tested in this trial
SHR-1701 neoadjuvant
DrugInduction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.
Treatment groups
Trial outcomes
Primary outcomes
pCR
No residual viable tumor cells in either the primary tumor site or the lymph nodes
Secondary outcomes
cCR
no evidence of any residual tumor was detected in the primary tumor site and regional lymph nodes
OS
Time from enrollment to death
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hong Qiu
Lead sponsor
Tongji Hospital
Sponsor institution