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NCT06254521RecruitingPhase 2

The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer

Neoadjuvant Treatment of Locally Advanced MSS Rectal Cancer With Tislelizumab Combined With CAPOX Regimen: a Prospective, Single-arm, Single-center, Exploratory Phase II Clinical Study

Source: ClinicalTrials.gov · Last updated 12 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced MSS rectal cancer.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
1 Jan 2024
Start date
22 Feb 2024
Primary completion date
30 Dec 2024
Lead sponsor
First Affiliated Hospital of Guangxi Medical University
NCT number
NCT06254521

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 22 Feb 2024 to the primary completion date, 30 Dec 2024
  • 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

  • Early rectal cancer (T1-2N0M0); The lower margin of the tumor was less than 5cm from the anus and T4. APR(combined abdominal perineal resection) is required;
  • 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 COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA score \> 3 points.
  • Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.

Other

  • 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 ≤70 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 less than 12cm from the anus as measured by colonoscopy and MRI,or TRUS.
  • It was confirmed by magnetic resonance imaging (MRI) or intracavitary ultrasound of the rectum as T3-4 or N+, and M0 by enhanced CT.
  • The ECOG 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.

Age in the registry: 18 years to - · 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
NanningChinaRecruiting

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