Intrahepatic Cholangiocarcinoma
Conditions
Keywords
intrahepatic cholangiocarcinoma, systemic chemotherapy, hepatic artery infusion chemotherapy
Brief summary
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.
Interventions
DRUGgemcitabine and cisplatin
administration of gemcitabine and cisplatin via vein
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Sponsors
Shi Ming
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis of ICC * Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria. * With no previous treatment * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * Without distant metastasis, but intrahepatic lymph node metastasis is allowed * The following laboratory parameters: 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
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known central nervous system tumors including metastatic brain disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 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 | 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. | 30 days | Postoperative adverse events were graded based on CTCAE v4.03 |
Countries
China
Outcome results
None listed