Colonic Neoplasms Clinical Trial
Official title:
Neoadjuvant Tislelizumab With Oxaliplatin and Capecitabine in Microsatellite Stable, Locally Advanced Colon Cancer: A Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study
This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced Microsatellite Stable (MSS) colon cancer.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 30, 2026 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age =18 years old and =75 years old. - Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma. - The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination. - Enhanced CT stage T4 or T1-4 N+ without multiple primary tumors or distant metastasis. - 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 chemotherapy contraindications. - 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 participate in the study, and will provide written informed consent. 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 is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis. - Tumor obstruction or high risk of obstruction, bleeding, and/or perforation requiring emergency surgery or stent placement. - Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression. - History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers. - Acute exacerbation of important organ diseases (such as but not limited to chronic obstructive 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 the understanding 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 to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Guangxi Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pCR | the proportion of tumor regression grades 0 (TRG0, disappearance of tumor cells) in the pathological specimens of surgically resected tumors. | 3-5 days of postoperative pathological examination | |
Secondary | R0 resection | the rate of a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. | 3-5 days of postoperative pathological examination | |
Secondary | Disease-free survival (DFS) | 3-year disease-free survival | From date of the patient signs the informed consent form until the date of earliest occurrence of the patient's tumor recurrence or death, whichever came first, assessed up to 36 months. | |
Secondary | Overall survival (OS) | 3-year overall survival | From the date of the patient signs the informed consent form until the date of the patient's death, assessed up to 36 months. | |
Secondary | Adverse events (AEs) | the rate of adverse events | up to half a year | |
Secondary | Immune-related adverse events (irAEs) | the rate of immune-related adverse events | up to half a year | |
Secondary | Surgical complication | the rate of surgical complication during or after operation. | From the day of surgery to 30 days after the operation, including intraoperative and postoperative complications. | |
Secondary | T lymphocyte | Cells with cellular immune function. The types and counts of T cells are analyzed using flow cytometry. | up to 3 months after surgery. | |
Secondary | Gene mutation signatures of colon cancer | Next-generation target sequencing is performed to analyze the gene mutation signatures. | up to 3 months before surgery |
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