The aim of this study is to evaluate the safety and efficacy of neoadjuvant immunotherapy combined with chemotherapy before colonic resection in patients with locally advanced colon cancers
The trial is designed as an investigator-initiated, single center, prospective, single arm phase II study in patients with locally advanced colon cancers scheduled for intended curative surgery to determine the efficacy of immunotherapy using tislelizumab in the neoadjuvant setting. Patients will receive CapeOX + Terelizumab therapy(Day 1 through Day 21) following diagnosis. After 3 weeks a re-evaluation (to assess tumor response) will be performed, followed by standard surgery for resection of the tumor. Surgery will therefore be performed within 3 to 5 weeks after 2 cycle of neoadjuvant combined immunotherapy.. The patients will be followed as per the standard Danish guidelines with CT scans at 1 and 3 years after surgery. The specimen collected by surgery and clinical data will be collected . We use Integrative omics analysis to establish a clinical efficacy prediction model by means of bioinformatics to prospectively judge the efficacy and guide the follow-up individualized and accurate treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
q3w Terelizumab 200mg on day 1 of each cycle
Oxaliplatin(130mg/m2) on day 1 of each cycle and Capecitabine:Dose of 1000mg/m2,14days
Daping hospital
Chongqing, China
Pathological complete response
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
Time frame: 6 months
ORR (objective response rate)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Time frame: 6 months
Major pathologic response (MPR)
It is defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy
Time frame: 6 months
Overall survival (OS)
Time from study entry to death from any cause.
Time frame: 2 years
Disease-free survival (DFS)
Time from study entry to disease recurrence or patient death due to disease progression
Time frame: 2 years
R0 resection rate
Rate of microscopically margin-negative resection
Time frame: 6 months
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