The goal of this clinical trial is to learn if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients compared with CapeOX. It will also learn about the safety of neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX. The main questions it aims to answer are: * Does neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX improve the pCR rate of mid-high pMMR/MSS locally advanced rectal cancer patients? * What medical problems do participants have when receiving neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX? Researchers will compare Fruquintinib and Tislelizumab combined with mCapeOX to CapeOX to see if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients. Participants will: * Receive Fruquintinib and Tislelizumab combined with mCapeOX or CapeOX before surgery up to 4 cycles * Receive radical operations and three years follow-up * Keep a diary of their postoperative pathology results and survival
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Receiving CapeOX treatment for up to four cycles before surgery: Capecitabine: 1000mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 130 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.
Receiving Fruquintinib plus Tislelizumab combined with mCapeOX treatment for up to four cycles before surgery: Fruquintinib: 3mg/d, QD, PO, Use for 2 weeks, stop for 1 week, Q3W; Tislelizumab: 200mg, D1, Intravenous infusion, Q3W; Capecitabine: 825mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 100 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.
Peking University Cancer Hospital & Institute
Beijing, Haidian District, China
Pathological complete response(pCR) rates
Pathological complete response(pCR) rates are defined as no viable tumor cells remaining in the primary tumor and lymph nodes (ypT0N0), that is, subjects with level 0 of the AJCC 8th edition Tumor Regression Grading (TRG) scoring system proportion.
Time frame: 10 days after surgery
Adverse events (AEs)
Adverse events (AEs) refer to adverse medical events that occur after clinical trial subjects receive a drug, but are not necessarily causally related to the treatment. AE can be any adverse and unexpected symptoms, signs, laboratory test abnormalities or diseases, etc., including at least the following situations: 1) Pre-existing medical conditions/diseases (before entering clinical trials) will be recorded as adverse events only if they worsen after starting to use the trial drug (including worsening of symptoms, signs, and laboratory test abnormalities); 2) Any new AE: any new adverse medical condition (including symptoms, signs, newly diagnosed diseases); 3) Abnormal clinically significant laboratory test results. Diagnostic or therapeutic invasive (such as surgery) and non-invasive procedures should not be reported as AEs, but when the disease condition that causes the procedures meets the definition of AE, they should be reported.
Time frame: From the beginning to the 21st day after the end of neoadjuvant treatment
Major Pathologic Response(MPR)
MPR: The proportion of residual viable tumor cells in the postoperative specimen in the tumor bed is less than or equal to 10%.
Time frame: 10 days after surgery
3-year event-free survival (EFS) rate
EFS is defined as the time from randomization to the occurrence of any of the following events, whichever occurs first: tumor disease progression on imaging as assessed by RECIST 1.1; tumor recurrence, including local recurrence or distant recurrence, as assessed on imaging or tissue biopsy transfer; death from any cause.
Time frame: 36 months after randomization
3-year overall survival (OS) rate
OS is defined as the time between the date of randomization and death from any cause.
Time frame: 36 months after randomization
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