A Phase 3 interventional study of irinotecan, oxaliplatin , fluorouracil, and leucovorin and gemcitabine and oxaliplatin in Intrahepatic Cholangiocarcinoma, sponsored by Shi Ming. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-05.
Sponsored by Shi Ming · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 188 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Shi Ming is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Exclusion Criteria:
Participants received hepatic artery infusion chemotherapy of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin
Drug: irinotecan, oxaliplatin , fluorouracil, and leucovorin
Participants received systemic chemotherapy of gemcitabine and oxaliplatin
Drug: gemcitabine and oxaliplatin
administration of irinotecan, oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
administration of gemcitabine and oxaliplatin via vein
Overall survival
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Time frame: 12 months
Progression free survival
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Time frame: 12 months
Time to progression
TTP was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Time frame: 12 months
Number of adverse events.
Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 30 days
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Shi Ming