Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer (NCT06124378) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer
China60 participantsStarted 2023-11-13
Plain-language summary
This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced Microsatellite Stable (MSS) colon cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ≥ 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 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…
What they're measuring
1
pCR
Timeframe: 3-5 days of postoperative pathological examination
Trial details
NCT IDNCT06124378
SponsorFirst Affiliated Hospital of Guangxi Medical University