HAIC Versus Systemic Chemotherapy for Unresectable ICC

Shi Ming

Status and phase: Unknown; Phase 3

Conditions: Intrahepatic Cholangiocarcinoma

Treatments: Drug: irinotecan, oxaliplatin , fluorouracil, and leucovorin; Drug: gemcitabine and oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03771846

S035

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Hepatic artery infusion chemotherapy

Experimental group

Description:

Participants received hepatic artery infusion chemotherapy of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin

Treatment:

Drug: irinotecan, oxaliplatin , fluorouracil, and leucovorin

Systemic chemotherapy

Active Comparator group

Description:

Participants received systemic chemotherapy of gemcitabine and oxaliplatin

Treatment:

Drug: gemcitabine and oxaliplatin