Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06124378
Other study ID # Minglin Lin
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 13, 2023
Est. completion date November 30, 2026

Study information

Verified date November 2023
Source First Affiliated Hospital of Guangxi Medical University
Contact Minglin Lin
Phone +86-771-5356529
Email linminglin@sr.gxmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Tislelizumab
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.
Oxaliplatin
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.
Capecitabine
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.
Procedure:
Colectomy
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.

Locations

Country Name City State
China The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

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
See also
  Status Clinical Trial Phase
Terminated NCT03746353 - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer N/A
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT06041945 - Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology N/A
Not yet recruiting NCT02688699 - Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract Phase 4
Not yet recruiting NCT03175146 - A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely N/A
Completed NCT02529007 - Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening N/A
Not yet recruiting NCT01929499 - Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer Phase 2
Completed NCT01681472 - PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer Phase 1/Phase 2
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Completed NCT00535652 - Concentration of Ertapenem in Colorectal Tissue Phase 4
Terminated NCT00267787 - Molecular Genetic and Pathological Studies of Anal Tumors
Completed NCT05498051 - Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW. N/A
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Recruiting NCT03314896 - Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial) N/A
Not yet recruiting NCT02852915 - Laparoscopic Surgery for T4 Tumor of the Colon Cancer Phase 3
Not yet recruiting NCT02777437 - Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer Phase 2/Phase 3
Completed NCT00997802 - Japanese National Computed Tomographic (CT) Colonography Trial N/A
Completed NCT01056913 - NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery Phase 4
Completed NCT00537901 - First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study N/A
Completed NCT00470782 - Aerobic Capacity and Body Composition in Colon Cancer Patients N/A