Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer

NCT06124378 | Active Not Recruiting Phase 2

• 1 other identifier: Minglin Lin
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonic Neoplasms; Neoadjuvant Therapy; Immune Checkpoint Inhibitors

Keywords

Colon cancer, Neoadjuvant chemotherapy; PD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• R0 resection

  3-5 days of postoperative pathological examination

• Disease-free survival (DFS)

  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.

• Overall survival (OS)

  From the date of the patient signs the informed consent form until the date of the patient's death, assessed up to 36 months.

• Adverse events (AEs)

  up to half a year

• Immune-related adverse events (irAEs)

  up to half a year

Study Arms (1)

Tislelizumab combined with Oxaliplatin and Capecitabine cohort

EXPERIMENTAL

Patients with locally advanced colon cancer who met the inclusion criteria received two or four cycles of Tislelizumab combined Capecitabine and Oxaliplatin regimen chemotherapy and were evaluated by enhanced CT. Then, these patients will receive curative surgery for colon cancer. Interventions: Drug: Oxaliplatin,130mg/m2 for chemotherapy on Day 1 every 3 weeks and repeat for 2 or 4 cycles. Drug: Capecitabine, Oral Capecitabine 1000 mg/m2 twice daily from Day 1 to Day 14 every 3 weeks and repeat for 2 or 4 cycles. Drug: Tislelizumab, 200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. Procedure: Colectomy

Drug: Tislelizumab; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: Colectomy

Interventions

Tislelizumab DRUG

200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The incidence of adverse events with Tislelizumab is relatively low. The Tislelizumab dose adjustment was implemented according to the prescribing information.

Also known as: Tevimbra

Tislelizumab combined with Oxaliplatin and Capecitabine cohort

Oxaliplatin DRUG

Oxaliplatin 130mg/m2 on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.

Also known as: Eloxatin

Tislelizumab combined with Oxaliplatin and Capecitabine cohort

Capecitabine DRUG

Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.

Also known as: Xeloda

Tislelizumab combined with Oxaliplatin and Capecitabine cohort

Colectomy PROCEDURE

The specific surgical approach is laparoscopic. The tumor blood supply is ligated and cut at the root of the mesentery, and the margin of resection should be no less than 10cm. Complete resection of the mesocolon (CME) is performed in conjunction.

Also known as: Surgery

Tislelizumab combined with Oxaliplatin and Capecitabine cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

tislelizumab; Oxaliplatin; Capecitabine; Colectomy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Surgical Procedures, Colorectal; Digestive System Surgical Procedures

Study Officials

• Sen Zhang

  First Affiliated Hospital of Guangxi Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: November 13, 2023
• Primary Completion: February 28, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)