the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma

Sun Yat-sen University

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: transarterial infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03777475

B2017-005-01

Details and patient eligibility

About

evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• older than 18 years old and younger than 75 years;
• ECOG PS≤1;
• proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
• not previous treated for tumor;
• unresectable;
• the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
• sign up consent

Exclusion criteria

• cannot tolerate TAI or surgery;
• known history of other malignancy;
• be allergic to related drugs;
• underwent organ transplantation before;
• be treated before (interferon included);
• known history of HIV infection;
• known history of drug or alcohol abuse;
• have GI hemorrhage or cardiac/brain vascular events within 30 days;
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

350 participants in 2 patient groups

low dose

Experimental group

Description:

low oxaliplatin (85mg/m2)

Treatment:

Procedure: transarterial infusion

high dose

Active Comparator group

Description:

high oxaliplatin (135mg/m2)

Treatment:

Procedure: transarterial infusion