Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer
Lead Sponsor:
First Affiliated Hospital of Guangxi Medical University
Conditions:
Colonic Neoplasms
Neoadjuvant Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced Microsatellite Stable (MSS) colon cancer.
Detailed Description
The standard treatment for locally advanced colon cancer is complete mesocolic excision (CME) followed by adjuvant chemotherapy. The MOSAIC and 16968 studies have shown that about 30% of patients expe...
Eligibility Criteria
Inclusion
- 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 ≥ 60g/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
- 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.
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06124378
Start Date
November 13 2023
End Date
November 30 2026
Last Update
September 24 2025
Active Locations (1)
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1
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021