HAIC With FOLFOX Versus Systemic Chemotherapy With GP for Unresectable ICC
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|ClinicalTrials.gov Identifier: NCT04961970|
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : July 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Intrahepatic Cholangiocarcinoma||Drug: oxaliplatin , fluorouracil, and leucovorin Drug: gemcitabine and cisplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma|
|Estimated Study Start Date :||July 9, 2021|
|Estimated Primary Completion Date :||July 9, 2025|
|Estimated Study Completion Date :||July 9, 2025|
Experimental: Hepatic artery infusion chemotherapy
Participants received hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin
Drug: oxaliplatin , fluorouracil, and leucovorin
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Active Comparator: Systemic chemotherapy
Participants received systemic chemotherapy of gemcitabine and cisplatin
Drug: gemcitabine and cisplatin
administration of gemcitabine and cisplatin via vein
- Overall survival [ Time Frame: 12 months ]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.
- Progression free survival [ Time Frame: 12 months ]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 to progression [ Time Frame: 12 months ]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).
- Number of adverse events. [ Time Frame: 30 days ]Postoperative adverse events were graded based on CTCAE v4.03
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): NCT04961970
|Cancer Center Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Ming Shi, MD 8620-87343115 firstname.lastname@example.org|