Phase
Condition
Colon Cancer
Colorectal Cancer
Treatment
Oxaliplatin
Tislelizumab
Colectomy
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years old and ≤75 years old.
Pathologically diagnosed MSS ((confirmed by microsatellite stable detection ornext-generation target sequencing) or (confirmed by immunohistochemistry)) colonadenocarcinoma.
The lower edge of the tumor is more than 12cm from the anus as measured bycolonoscopy and the lower edge of the tumor cannot be directly palpated duringrectal examination.
Enhanced CT stage T4 or T1-4 N+ without multiple primary tumors or distantmetastasis.
The Eastern Cooperative Oncology Group physical status score is 0-1.
Life expectancy is expected to be more than 1 year.
First diagnosis, no previous anti-tumor treatment received, and no chemotherapycontraindications.
Appropriate organ function is defined as follows: Hemoglobin level ≥ 90g/L,Neutrophil count ≥ 1.5×10^9/L, Platelet count ≥ 75×10^9/L, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate aminotransferase (AST) ≤ 2× UNL,Alanine aminotransferase (ALT) ≤ 3× UNL, Serum creatinine ≤ 1.5× UNL.
Informed consent, able to understand the study protocol and willing to participatein the study, and will provide written informed consent.
Exclusion
Exclusion Criteria:
Enhanced CT stage (T1-3N0M0)
Multifocal colorectal cancer.
CT or MRI in the mid-sagittal plane shows that the lower border of the tumor isbelow the line connecting the sacrococcygeal promontory and the upper border of thepubic symphysis.
Tumor obstruction or high risk of obstruction, bleeding, and/or perforationrequiring emergency surgery or stent placement.
Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bonemarrow suppression.
History of malignant tumors, except for basal cell carcinoma, papillary thyroidcarcinoma, and various in situ cancers.
Acute exacerbation of important organ diseases (such as but not limited to chronicobstructive pulmonary disease, coronary heart disease, and renal insufficiency)and/or severe acute infectious diseases (such as but not limited to hepatitis,pneumonia, and myocarditis), American Society of Anesthesiologists score > 3 points.
Mental disorders, illiteracy, or language communication barriers that prevent theunderstanding of the study protocol.
Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.
Continuous use of glucocorticoids for more than 3 days within 1 month prior tosigning the informed consent form, or having comorbidities requiring the use ofglucocorticoid therapy.
Unable to undergo enhanced CT examination
Pregnancy or lactation.
Refused to participate in this study.
Other situations in which the researcher deems unsuitable for this study.
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi 530021
ChinaActive - Recruiting
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