A Phase 2 interventional study of Oxaliplatin and S1 in Preventive Effect of Quintuple Therapy on Metachronous Liver Metastases in Patients With Colorectal Cancer, sponsored by Liaoning Cancer Hospital & Institute. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Liaoning Cancer Hospital & Institute · Phase 2, Interventional, and Treatment
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.
Patients diagnosed with colorectal cancer, clinical stage I to III, underwent radical surgery, and prehepatic CTC≥1 were enrolled. Patients were randomly divided into Conventional treatment group and Quintuple method treatment group. Patients in the Conventional treatment group received conventional treatment according to the NCCN Guidelines for Colorectal Cancer 2023 edition. For patients in the Quintuple method treatment group, Quintuple method intervention was adopted, that is, combined with SOX regimen chemotherapy, low-dose cetuximab targeted therapy and three-drug regimen of folic acid, vitamin A and metronidazole. 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 Digio, 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. The above regimen lasted for 6 to 8 sessions, and enrolled patients were reviewed every 3 months for colorectal cancer-related tumor markers, including MRI and CT imaging. The primary endpoint was radiographically confirmed metachronous liver metastases, and the secondary endpoint was death, observed for 3 years.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 100 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
Conventional treatment was performed according to the NCCN Guidelines for Colorectal Cancer 2023 Edition
Drug: Oxaliplatin · Drug: Capecitabine
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.
Drug: Oxaliplatin · Drug: S1 · Drug: Cetuximab · Drug: Metronidazole · Drug: Vitamin A · Drug: Folic acid
Oxaliplatin via intravenous drip on d1 at a dose of 130mg/m2 × patient 's body surface area
Orally on d2-d15 at 20 mg three times daily
Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.
Metronidazole 0.4g/time, qd
Vitamin A 25,000 units/time, qd
Folic acid 0.4 mg/time, qd
Capecitabine via orally on d2-d15 two times daily at a dose of 1000mg/m2 × patient 's body surface area.
Metachronous liver metastasis rate
The Metachronous liver metastasis rate is the proportion of CTC-positive patients with metachronous liver metastases after conventional therapy or quintuple method intervention.
Time frame: Up to approximately 3 years
Overall Survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time.
Time frame: Up to approximately 3 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Liaoning Cancer Hospital & Institute