Clinical trial · Interventional
Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, the Quintuple method was applied for early intervention of prehepatic CTC-positive bowel cancer patients without dominant liver metastasis, aiming to explore the blocking effect of the Quintuple method on the metachronous liver metastases of colorectal cancer. A one-arm randomized clinical trial was conducted, and the patients were grouped according to their treatment methods. The patients with metachronous liver metastases were used as the end point of the experiment to evaluate the blocking effect of quintuple therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Preventive Effect of Quintuple Therapy on Metachronous Liver Metastases in Patients With Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Folic acid | Drug | — | UNRESOLVED |
| Metronidazole | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S1 | Drug | — | UNRESOLVED |
| Vitamin A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Conventional treatment group
- description
- Conventional treatment was performed according to the NCCN Guidelines for Colorectal Cancer 2023 Edition
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- Quintuple method treatment group
- description
- SOX regimen chemotherapy, low dose cetuximab targeted therapy, and folic acid, vitamin A, metronidazole three-drug regimen were combined. Specific drug dosages were as follows: SOX regimen was administered every three weeks, d1 was given oxaliplatin intravenously, the dosage was 130mg/ m2 \* patient's body surface area, d2-d15 was taken orally by S1, 20mg three times a day each time. Cetuximab combined with chemotherapy was administered intravenously, once every three weeks, before oxaliplatin, and the dosage was 250mg/ m2 \* patient's body surface area. Metronidazole 0.4g/ time, once a day; Vitamin A 25,000 units/time, once a day; Folic acid 0.4mg/ time, once a day. The last three drugs were continued until the end of all chemotherapy cycles. These regimens last for 6 to 8 sessions.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ages 18-80 at the time of signing the informed consent; 2. Histologically or cytologically confirmed adenocarcinoma of the colon or rectum; 3. Radical surgery has been performed; 4. Imaging examination showed no liver metastasis; 5. Prehepatic CTC number ≥1; 6. The ECOG performance status is 0-1. 7. No combination of other life-threatening diseases; 8. Willingness and ability to follow scheduled visits, treatment plans, laboratory tests and other research procedures. Exclusion Criteria: 1. Patients with non-primary colorectal cancer; 2. Patients with liver metastasis or other organ metastasis; 3. Patients without prehepatic CTC or whose prehepatic CTC were negative; 4. People who are severely allergic to one or more of the drugs required in the test; 5. Patients with severe underlying diseases of respiratory, circulatory, urinary and hematopoietic systems.
References
Publications (0)
Data not yet available