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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Tolecizumab (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
1\. 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.
Daping Hospital Third Military Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGpCR
pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes
Time frame: The pCR rate will be evaluated after surgery, an average of 12 weeks
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
Time frame: MPR rate assessed postoperatively, at an average of 12 weeks
Disease-free survival
Defined as the time from randomization to relapse or death, whichever occurred first.
Time frame: 3 years
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
Time frame: 3 years
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).
Time frame: From enrollment to 12 Weeks of treatment end
R₀ (Curative) resection
Curative resection defined as complete tumor resection with all margins being negative.
Time frame: Surgical operation assessment
Objective Response Rate (ORR)
Objective response is defined as a complete response (CR) or response (PR) according to RECIST v1.1
Time frame: After 4 cycles of neoadjuvant therapy (10 weeks)
Radiological response based on RECIST 1.1 criteria: CR, PR, SD, PD
Time frame: From enrollment to 12 Weeks of treatment end
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