Overview

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