ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal
| Condition(s) | Colorectal Cancer, Liver Metastases, Circulating Tumor Cell, Chemotherapy Effect |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar. |
| Who can participate | Inclusion Criteria: 1. Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy; 2. Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects); 3. Patients with negative ctDNA after surgery; 4. ASA grade \<IV and/or ECOG performance status score ≤ 2; 5. Have sufficient understanding of the study and voluntarily sign an informed consent form. Exclusion Criteria: 1. Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.; 2. Patients with a history of other malignancies; 3. Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious und |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2023-02-20 |
| NCT ID | NCT05815082 |
| Official listing | https://clinicaltrials.gov/study/NCT05815082 |