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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Oct 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced rectal cancer. The goal is to see if using a special test that detects circulating tumor DNA (ctDNA) can help guide treatment decisions. ctDNA is a marker that can give doctors important information about the cancer, which may help customize therapy to fit each patient's specific needs. The trial will explore how well this personalized treatment works, especially when combined with immunotherapy, which helps the immune system fight cancer.

To participate in this study, you need to be between 18 and 75 years old and have a specific type of rectal cancer that hasn't been treated before. You should also be in good overall health to tolerate the treatments being studied. If you decide to join, you can expect to receive tailored treatment plans based on your cancer's characteristics and may have the opportunity to receive innovative therapies. The study is currently looking for participants, and your involvement could contribute to important findings in cancer care.

Gender

ALL

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.