HAIC With FOLFOX Versus Systemic Chemotherapy With GP for Unresectable ICC

Sponsor

Shi Ming (Other)

Overall Status

Recruiting

CT.gov ID

NCT04961970

Collaborator

(none)

188

Enrollment

Location

Arms

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Drug: oxaliplatin , fluorouracil, and leucovorin Drug: gemcitabine and cisplatin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma

Anticipated Study Start Date :

Jul 9, 2021

Anticipated Primary Completion Date :

Jul 9, 2025

Anticipated Study Completion Date :

Jul 9, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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