Using circulating tumor DNA to guide treatment for advanced rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on patients with locally advanced rectal cancer and aims to improve treatment outcomes by utilizing circulating tumor DNA (ctDNA) to guide neoadjuvant therapy. It will assess the prognostic value of ctDNA to tailor treatment intensity based on individual tumor burden, thereby optimizing therapy for patients at high risk of recurrence while minimizing overtreatment for those at low risk. The study will also explore the potential benefits of combining immunotherapy with traditional treatment approaches. By implementing a personalized treatment strategy, the study seeks to enhance systemic disease control and long-term survival rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-75 years;
2. ECOG score 0-2;
3. Rectal adenocarcinoma confirmed by pathology;
4. The lower margin of the tumor was less than 12cm from the anal margin;
5. Patients with clinical stage cT3-4N0M0 or cTanyN+M0;
6. Newly treated patients who have not received treatment including radiotherapy, chemotherapy and surgery;
7. Liver, kidney and other organs have good function and can tolerate radiotherapy, chemotherapy and surgery;
8. Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.

Exclusion Criteria:

1. ECOG score \> 2;
2. Patients with multiple primary colorectal cancers;
3. A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;
4. Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery;
5. pregnant or lactating women;
6. Patients with a history of severe mental illness, immune disease, hormone medication;
7. Patients contraindicated by MRI examination, chemoradiotherapy, immunotherapy or surgery;
8. Participated in other clinical researchers in the past 3 months;
9. Any other circumstances that the investigator considers inappropriate for inclusion.

Where it's running

• Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences,
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Lin guole, Doctor
• Email: linguole@126.com
• Phone: 13801081483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.