NCT06124378Active, not recruitingPhase 2
Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer
Neoadjuvant Tislelizumab With Oxaliplatin and Capecitabine in Microsatellite Stable, Locally Advanced Colon Cancer (NETSAC): A Single-arm, Single-center, Exploratory Phase II Clinical Study
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced Microsatellite Stable (MSS) colon cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 Nov 2023
- Start date
- 13 Nov 2023
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT06124378
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 13 Nov 2023 to the primary completion date, 28 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression.
- 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.
Other illness
- Multifocal colorectal cancer.
- Tumor obstruction or high risk of obstruction, bleeding, and/or perforation requiring emergency surgery or stent placement.
- 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.
Other
- Enhanced CT stage (T1-3N0M0)
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.