Phase II Trial of Sorafenib Combined With Concurrent HAIC for Hepatocellular Carcinoma

Sun Yat-sen University

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: Hepatic arterial infusion chemotherapy

Drug: Folfox Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT02981498

HCC-S027

Details and patient eligibility

About

To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular carcinoma (HCC).

Full description

In most current guidelines, unresectable HCC with major PVTT are considered not generally suitable for transarterial chemoembolization, and sorafenib is recommended as standard care.3-5 However, for patients with major PVTT, the median overall survival of those treated with sorafenib monotherapy was only 3.1 to 6.0 months.

Whether combining sorafenib with hepatic arterial infusion (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective single center, single-arm phase II trial to evaluate the safety and efficacy of sorafenib combined with HAIC in patients with unresectable advanced HCC.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Criteria:

Inclusion Criteria:

The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
diagnosed with major or main portal vein invasion (Vp3 or Vp4)
KPS≥70；
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.
The following laboratory parameters:
- Platelet count ≥ 75,000/µL
- Hemoglobin ≥ 8.5 g/dL
- Total bilirubin ≤ 30mmol/L
- Serum albumin ≥ 30 g/L
- ASL and AST ≤ 5 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
Ability to understand the protocol and to agree to and sign a written informed consent document

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.
Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Serious non-healing wound, ulcer, or bone fracture
Known central nervous system tumors including metastatic brain disease