HAIC Versus Systemic Chemotherapy for Unresectable ICC

Phase 3

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Drug: irinotecan, oxaliplatin , fluorouracil, and leucovorin; Drug: gemcitabine and oxaliplatin

• Registration Number: NCT03771846
• Lead Sponsor: Shi Ming

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-12-09
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-05
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepatic artery infusion chemotherapy	irinotecan, oxaliplatin , fluorouracil, and leucovorin	Participants received hepatic artery infusion chemotherapy of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin
Systemic chemotherapy	gemcitabine and oxaliplatin	Participants received systemic chemotherapy of gemcitabine and oxaliplatin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.

Trial Locations

Locations (2)

Ming Shi; 🇨🇳 Guangzhou, Guangdong, China

Cancer Center Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China