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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Watching and waiting group | Experimental | Watch and Wait strategy is one of the treatment strategies of advanced rectal cancer, which recommends no immediate surgery with close surveillance. |
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| Adjuvant chemotherapy group | Active Comparator | Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorectal cancer resection combined with liver metastasis resection. | Procedure | The preferred surgical approach is resection of the corresponding colon segment with regional lymph node dissection. If conditions permit, synchronous resection of the primary lesion and liver metastases of colorectal cancer can be performed to achieve curative resection. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year progression-free survival | PFS is defined as the time from randomization to the occurrence of any progression or death from any cause. | 3 years after operation. |
| 5-year progression-free survival | PFS is defined as the time from randomization to the occurrence of any progression or death from any cause. | 5 years after operation. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival | Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded. | 3 years after operation. |
| 3-year overall survival |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliate Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | China |
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| FOLFOX chemotherapy regimen | Drug | Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy. |
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Overall survival is defined as the time from randomization to death from any cause. For patients who are still alive at the time of the final analysis, the date of the last contact will be recorded. |
| 5 years after operation. |
| Complications | When evaluating the safety and tolerability of adjuvant therapy, researchers typically assess adverse events (AEs) based on their incidence and severity, and then grade them according to the NCI CTCAE version 5.0. NCI CTCAE 5.0 categorizes AEs into 5 grades based on severity, including grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). | 5 years. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
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