A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM
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|ClinicalTrials.gov Identifier: NCT03493061|
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colo-rectal Cancer Liver Metastases||Drug: Irinotecan Drug: Oxaliplatin Drug: Floxuridine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Systemic Chemotherapy With Irinotecan Plus Hepatic Arterial Infusion With Floxuridine and Oxaliplatin in Patients With Initially Unresectable Colorectal Liver Metastasis: A Prospective Study|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: Systemic CPT-11 + HAI (FUDR+L-OHP)
Patients will receive Systemic CPT-11 + HAI (FUDR+L-OHP) every 28 days:
Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; followed by Oxaliplatin 85 mg/m2 over 3 hours through the HAI pump on Day 1 and 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.
then Irinotecan 150 mg/m2 IV over 90 minutes on Day 15, followed by Oxaliplatin 85 mg/m2 IV over 3 hours on Day 15.
This will be repeated on Day 1 of each 28-day cycle. FUDR will be administered through a 14-day continuous infusion with the HAI pump.
Irinotecan 150 mg/m2 IV over 90 minutes on Day 1, 15
Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.
0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.
- Complete resection rates (R0 resection rates) [ Time Frame: Up to 2-4 months ]defined as no macroscopic or microscopic residual tumor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493061
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Li Yuhong, MD 020-87342487 firstname.lastname@example.org|
|Principal Investigator: Li Yuhong, MD|