Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT07393048

Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer

Led by Beijing Friendship Hospital · Updated on 2026-04-21

60

Participants Needed

1

Research Sites

150 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study is a single-center, prospective, observational clinical trial enrolling patients with locally advanced rectal cancer (cT3-4aN0M0 and cT1-4aN1-2M0). By collecting tissue and blood samples at multiple timepoints, and integrating multi-omics data including ctDNA mutations, copy number variations, and mtDNA profiles, a multi-omics model will be constructed to predict the efficacy of neoadjuvant therapy for rectal cancer.

CONDITIONS

Official Title

Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed a written informed consent form and voluntarily agreed to participate
  • Aged 18 to 75 years, any gender
  • Histopathologically confirmed rectal adenocarcinoma
  • Clinical stage II-III rectal cancer assessed by MRI according to AJCC 8th edition
  • Tumor located within 10 cm from the anal verge
  • Tumor is surgically resectable
  • Ability to swallow tablets normally
  • ECOG performance status of 0 or 1
  • No prior antitumor therapy for rectal cancer, including surgery, chemotherapy, or radiotherapy
  • Scheduled to have surgery after completing neoadjuvant therapy
  • No contraindications for surgery
  • Normal major organ function, including blood counts, biochemistry, and coagulation
Not Eligible

You will not qualify if you...

  • History of allergy to monoclonal antibodies, tislelizumab, capecitabine, or their components
  • Prior or ongoing tumor-directed treatments including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy
  • Active or past autoimmune diseases
  • Immunodeficiency conditions including positive HIV, organ transplantation, or bone marrow transplantation
  • Poorly controlled cardiac conditions such as NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmia
  • Diagnosis of another cancer within 5 years except for low-risk skin cancers or cervical carcinoma in situ
  • Pregnant or breastfeeding women
  • Other severe conditions or factors that may affect safety or study compliance as judged by the investigator, including psychiatric disorders, substance abuse, or social factors

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Friendship Hospital

Beijing, Beijing Municipality, China, 100050

Actively Recruiting

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Research Team

Y

Yao Hongwei Professor, Doctoral Degree

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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