Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Sep 6, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer," is investigating how circulating tumor DNA (ctDNA) can help doctors decide the best chemotherapy treatment for patients with colon cancer after surgery. The focus is on understanding whether some patients with lower-risk colon cancer can receive less chemotherapy without affecting their chances of survival. The study also looks at how ctDNA levels can indicate the risk of cancer returning, which can help tailor treatment plans.

To be eligible for this trial, participants must be between 18 and 75 years old and have a specific type of colon cancer confirmed by a doctor. They should have either stage II colon cancer with certain high-risk features or stage III colon cancer without spread to other parts of the body. Patients will be randomly assigned to different treatment schedules based on their ctDNA results. Throughout the trial, participants can expect regular monitoring and support from the medical team as they receive their assigned treatments. It's important to note that the trial is still recruiting participants, and those interested should discuss it with their healthcare provider to learn more.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18 to 75
• • 2. Colon adenocarcinoma confirmed by pathology (including high and high differentiated tubular adenocarcinoma, papillary adenocarcinoma, low differentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma)
• • 3. Postoperative pathology is stage II with high-risk factors or stage III;
• High risk stage II refers to stage II colon cancer with at least one of the following:
• • a) T4 stage; b) The number of lymph nodes detected was less than 12; c) Poor differentiation (except MSI-H); d) Complicated with LVI or PNI；e) Complicated with obstruction or perforation.
• • 4. No distant metastasis was found in preoperative imaging examination and operation;
• • 5. ECOG score: 0-2 points;
• • 6. MSS/pMMR and BRAF wild type
• • 7. Start time of chemotherapy is less than 2 months from the operation
• • 8. Have sufficient organ functions;
• 9. The baseline blood routine and biochemical indexes of the subject meet the following standards:
• • hemoglobin ≥ 9.0 g / dl;
• • absolute neutrophil count (ANC) ≥ 1500 / mm3;
• • platelet count ≥ 100000 / mm3;
• • total bilirubin ≤ 1.5 times the upper limit of normal value (ULN);
• • glutamic pyruvic transaminase and glutamic oxalic transaminase ≤ 2.5 times ULN;
• • creatinine ≤ 1.5 times ULN;
• • 10. Patients or family members who can understand the study protocol and are willing to participate in the study shall provide written informed consent.
• Exclusion Criteria:
• • 1. Receive chemotherapy, radiotherapy or immunotherapy before operation
• • 2. History of malignant tumor in the past 5 years (except fully cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial cell skin cancer)
• • 3. Pregnant women
• • 4. Serious mental illness
• • 5. Those with poor physical condition and difficult to complete chemotherapy
• • 6. Patients or family members cannot understand the conditions and objectives of this study