Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05601505

Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer

Led by Peking Union Medical College Hospital · Updated on 2024-12-24

470

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Rectal cancer still remains one of the most popular tumors, however, distance metastasis still remains as high as 30% and the long-term survival outcomes are still unsatisfying. The recent conception of total neoadjuvant therapy and immune therapy is becoming popular and the oncologic effects are encouraging, especially in terms of circulating tumor DNA (ctDNA), the prognostic value of ctDNA has been demonstrated by our prior study. This study will carry out accurate ctDNA-guided neoadjuvant therapy on the basis of previous studies of the research group, and give appropriate treatment plans and treatment intensity to patients with different disease degrees. At the same time, combined with the latest progress in clinical diagnosis and treatment, the potential beneficiaries of immunotherapy were screened scientifically, and the combined immunotherapy was implemented accordingly.

CONDITIONS

Official Title

Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-75 years
  • ECOG performance status score between 0 and 2
  • Rectal adenocarcinoma confirmed by pathology
  • Tumor located less than 12 cm from the anal margin
  • Clinical stage cT3-4N0M0 or cTanyN+M0
  • Newly diagnosed and untreated with radiotherapy, chemotherapy, or surgery
  • Adequate liver, kidney, and organ function to tolerate treatment
  • Ability to understand the study and provide informed consent
Not Eligible

You will not qualify if you...

  • ECOG score greater than 2
  • Multiple primary colorectal cancers
  • History of other cancers within 5 years except specific cured types
  • Complications requiring emergency surgery such as intestinal obstruction or bleeding
  • Pregnant or lactating women
  • History of severe mental illness, immune disease, or hormone therapy
  • Contraindications to MRI, chemoradiotherapy, immunotherapy, or surgery
  • Participation in other clinical trials within the past 3 months
  • Any other condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences,

Beijing, Beijing Municipality, China, 100005

Actively Recruiting

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Research Team

L

Lin guole, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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