This multicenter, randomized, open-label, blinded-endpoint Phase II trial assesses the efficacy and safety of tolecizumab (PCSK9 inhibitor) plus sintilimab/CapeOX chemoimmunotherapy as neoadjuvant treatment for pMMR/MSS locally advanced colon adenocarcinoma .
Signed the written informed consent form and voluntarily participate in the study.
Pathohistologically confirmed colon adenocarcinoma with cT3c stage or above.
Aged 18 to 80 years, regardless of gender.
The lower edge of the tumor is more than 10 cm from the anus.
Previous anti-tumor treatment for the current colon cancer.
Previous use of PCSK9 inhibitors or PD-1/PD-L1 inhibitors.
Active autoimmune diseases or a history of autoimmune diseases.
Receiving immunosuppressant or systemic glucocorticoid therapy (except for local low-dose glucocorticoid use).
Parallel
Tafolecimab
DrugTolecizumab (PCSK9 Inhibitor) 600mg, subcutaneous injection, Q6W (Weeks 1,7), 2 doses total Sintilimab (PD-1 Inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), 4 cycles total CapeOX Regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg/m² IV Q3W (4 cycles); Capecitabine 1000mg/m² oral twice daily, Days1-14 per cycle
Sintilimab
Drug1\. Oxaliplatin: 130mg/m² intravenous infusion, Q3W at Week 1,4,7,10, total 4 cycles; 2. Capecitabine: 1000mg/m² oral administration, twice daily, Days 1-14 of each chemotherapy cycle. All drugs free of charge. 2.Sintilimab 200mg intravenous infusion, administered every 3 weeks (Q3W) at Week 1, 4, 7, 10, total 4 cycles; provided free of charge by the sponsor, used for neoadjuvant immunotherapy.
pCR
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
MPR (Major Pathological Response)
MPR is defined as ≤10% residual viable tumor cells in the primary tumor bed of the surgical specimen following neoadjuvant therapy
Disease-free survival
Defined as the time from randomization to relapse or death, whichever occurred first.
Overall survival (OS)
Defined as the time from randomization to date of death due to any cause according to RECIST version 1.1 recorded in the time period between randomization and disease
Primary tumor downstaging rate
Down-staging of the resected tumour as measured by histopathological tumour diameter and stage according to the TNM staging system of AJCC (9th version).
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead sponsor
Shapingba District People's Hospital
Collaborator
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
Jiangbei Campus of The First Affiliated Hospital of Army Medical University (Army 958 Hospital)
Collaborator
Third Affiliated Hospital of Chongqing Medical University
Collaborator
Chongqing Yongchuan District People's Hospital, Deyang People's Hospital
Collaborator
Guang'an People's Hospital, Kaizhou District People's Hospital
Collaborator
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Collaborator
