HAIC With FOLFOX Versus Systemic Chemotherapy With GP for Unresectable ICC

• Status: Recruiting
• Trial end date: 2025-07-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shi Ming
• Treatments: Fluorouracil; Gemcitabine; Leucovorin; Oxaliplatin

Criteria

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