Hepatocellular Carcinoma
Conditions
Brief summary
Hepatocellular carcinoma (HCC) is a common disease in East Asia. Less than 20% of newly diagnosed patients can undergo radical resection. For those with unresectable BCLC C stage, transarterial chemotherapy and targeted therapy are recommend to prolong survival. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Transartery infusion of agents provide promising outcome when compared systemic infusion. Furthermore, our pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC plus hepatic artery infusion PD-1 antibody would improve survival for unresectalbe BCLC C stage patients is still unknown. A single arm, phase 2 clinical trial is aimed to answer this question.
Interventions
DRUGPD-1 inhibitor
Transarterial hepatic chemoembolization and FOLFOX-based infusion
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Trans hepatic arterial infusion of PD-1 antibody, chemoembolization and FOLFOX-based chemotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* BCLC C stage with unresectable diseasehigh-recurrence risk factor; * Child-Pugh A or B (7 score) liver function; * Anticipated survival more than 3 moths
Exclusion criteria
* Pregnant woman or sucking period; * With other malignant cancer; * Received anti-HCC therapy before this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | 12 month | defined as the sum of complete responses (CRs) and partial responses (PRs) over a specified time period |
Countries
China
Contacts
Primary ContactJiliang Qiu
Backup ContactXuzhi Pan
Outcome results
None listed