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The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant chemotherapy combined with maintenance therapy | Experimental |
| |
| Single adjuvant chemotherapy | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorectal resection surgery. | Procedure | Colorectal cancer radical resection combined with liver metastasis resection or ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-years 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-years 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-years 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. |
| 5-years overall survival |
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Inclusion Criteria:
Exclusion 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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| Capecitabine | Drug | Maintenance therapy is recommended to be continued with low-toxicity drugs such as 5-FU/LV or capecitabine, and may be combined with targeted therapy. Treatment should be discontinued once ctDNA testing is negative. |
|
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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. |
| Complication | he complications of adjuvant therapy usually refer to the adverse events that occur during or after treatment, including but not limited to chemotherapy-related adverse reactions, radiation therapy-related adverse reactions, and postoperative complications. Specifically, chemotherapy-related adverse reactions may include nausea, vomiting, diarrhea, anemia, and infections; radiation therapy-related adverse reactions may include skin inflammation, nausea, vomiting, diarrhea, fatigue, and dry mouth; postoperative complications may include bleeding, infection, intestinal obstruction, and poor wound healing. Researchers typically record the types, severity, and impact of these complications on treatment to evaluate the safety and tolerability of adjuvant therapy. | 5 years. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| D016609 | Neoplasms, Second Primary |
| 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 |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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