Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06254521

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

Led by First Affiliated Hospital of Guangxi Medical University · Updated on 2024-02-12

60

Participants Needed

1

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.
  • 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 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.
  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China, 530021

Actively Recruiting

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Research Team

S

Sen Zhang, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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