Using circulating tumor DNA to guide treatment for advanced rectal cancer

Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer --- a Multicenter Randomized Controlled Trial (CINTS-R)

This study is testing if using a blood test to check for tumor DNA can help doctors give better treatment to people with advanced rectal cancer by personalizing their therapy based on their risk of recurrence.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 470 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05601505 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed rectal adenocarcinoma and specific clinical staging who have not previously received treatment.

Not a fit: Patients with poor performance status (ECOG score > 2) or those with multiple primary colorectal cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and reduced recurrence in patients with locally advanced rectal cancer.

How similar studies have performed: Previous studies have shown promising results using ctDNA as a prognostic marker, indicating that this approach has potential based on earlier findings.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions: Locally Advanced Rectal Carcinoma, Circulating Tumor DNA, Locally advanced rectal cancer, circulating tumor DNA, Neoadjuvant chemoradiotherapy, Total neoadjuvant therapy, Randomized Controlled Trial