Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer

Last updated: February 24, 2025
Sponsor: First Affiliated Hospital of Guangxi Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Colon Cancer

Colorectal Cancer

Treatment

Oxaliplatin

Tislelizumab

Colectomy

Clinical Study ID

NCT06124378
Minglin Lin
  • Ages 18-75
  • All Genders

Study Summary

This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced Microsatellite Stable (MSS) colon cancer.

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

Total Participants: 60
Treatment Group(s): 6
Primary Treatment: Oxaliplatin
Phase: 2
Study Start date:
November 13, 2023
Estimated Completion Date:
November 30, 2026

Study 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 experience recurrence and metastasis within 6-7 years after surgery. Neoadjuvant chemotherapy may improve the prognosis of colon cancer patients. The significant tumor remission after neoadjuvant therapy probably indicates a better long-term survival for patients. The OPTICAL and Fluoropyrimidine Oxaliplatin and Targeted Receptor Pre-Operative Therapy (FoxTROT) studies have shown that approximately 35% of patients are resistant to oxaliplatin-containing neoadjuvant chemotherapy, with a pathological complete response (pCR) rate of less than 10% and uncertain survival improvement. Moreover, previous study shown that immunotherapy has unsatisfied efficacy for microsatellite stable (MSS) colon cancer. Therefore, it is necessary to explore more effective neoadjuvant treatment strategy for tumor therapy.

Immunogenic cell death will be enhanced by oxaliplatin-induced immunogenicity and combined with anti-programmed cell death 1 (PD-1) monoclonal antibodies for neoadjuvant therapy. The study will conduct 2 or 4 cycles of Tislelizumab with Oxaliplatin and Capecitabine, followed by CME surgery. The study's primary endpoint is the proportion of pCR in the pathological specimens of surgically resected tumors.

Connect with a study center

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.