Sign in

NCT07132008Not yet recruitingPhase 3

Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer

Prospective, Multicenter, Randomized Trial of Neoadjuvant Capecitabine and Oxaliplatin (CAPOX) Plus Tislelizumab Versus CAPOX in Microsatellite Stable High-risk Locally Advanced Colon Cancer

Source: ClinicalTrials.gov · Last updated 20 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Building on earlier exploratory work, this study further designs a multi-institutional, prospective, randomized clinical trial to evaluate the efficacy and safety of the combination therapy of the immune checkpoint inhibitor Tislelizumab with CAPOX for neoadjuvant treatment in high-risk locally advanced MSS-type colorectal cancer, as well as its impact on patient outcomes. This study aims to provide new evidence for the clinical practice of treating MSS-type colorectal cancer.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
94 (estimated)
First submitted
13 Aug 2025
Start date
1 Oct 2025
Primary completion date
30 Sept 2027
Lead sponsor
First Affiliated Hospital of Guangxi Medical University
NCT number
NCT07132008

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 94
  • From 1 Oct 2025 to the primary completion date, 30 Sept 2027
  • 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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Guangxi Medical University
Coordinator of this site? Confirm its status
NanningChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.