To determine the Efficacy and Safety of camrelizumab and apatinib combined with chemotherapy (mFOLFOX6) for MSS/pMMR locally advanced colon cancer.
To determine the rate of tumor regression grade 2-4 at time of radical resection of MSS/pMMR colon cancer following neoadjuvant treatment.To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment, pathologic complete response (pCR) rates, R0 resection rate, 2 year Disease free survival, OS(overall survival) and adverse events, including perioperative complication and mortality rate. To determine the pathologic downstage rates and pCR rate of radical resection of MSI/dMMR colon cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Camrelizumab 200 mg, IV infusion on Days 1 each 14-day cycle Apatinib 250mg oral administration once a day, for two months mFOLFOX6 oxaliplatin 85 mg/m\^2 IV infusion on Day 1 of each14-day cycle. Fluorouracil: 400 mg/m2 as a bolus injection given after a two-hour leucovorin infusion at a dose of 400 mg/m2. The loading dose is then followed by a 46-hour 5-fluorouracil infusion of 2,400 mg/m2 via a pump programmed to provide a constant drug infusion rate.
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China
Tumor Regression Rate of MSS/pMMR Patients
the percentage of tumor regression rate (2-4) in pMMR patients
Time frame: 2 years
Pathologic Complete Response (pCR) Rates
Percentage of patients with pathological complete response
Time frame: 2 years
R0 Resection Rate
R0 resection accounted for the percentage of all surgical patients=100%
Time frame: 2 years
The Rate of 2 Year Disease Free Survival (DFS)
Disease-free survival (DFS) is defined as the time from operation to recurrence of tumor or death. We will evaluate 2 year DFS is 100%
Time frame: 2 years
Overall Survival (OS)
Refers to the time of death from enrollment to any cause
Time frame: 2 years
Event Free Survival (EFS)
The period from the beginning of neoadjuvant therapy to the occurrence of any of the following events, whichever occurs first: tumor progression as assessed by RECIST 1.1; Tumor recurrence, including local recurrence or distant metastasis; Death from any cause; EFS=100%
Time frame: 2 years
Perioperative Complication Rate
The complication rate of all patients during the period around the time of a surgical operation
Time frame: 3 months
Mortality Rate
the ratio between deaths and all patients in the study during treatment
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Time frame: 2 years