A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of HCC Combined With PVTT After Hepatic Resection

Cancer Hospital of Guangxi Medical University

Status

Unknown

Conditions

Hepatocellular Carcinoma

Treatments

Drug: PD-1 antibody

Procedure: TACE

Study type

Interventional

Funder types

Other

Identifiers

NCT03914352

CHGuangxiMU

Details and patient eligibility

About

Hepatic resection is the most effective curative treatment for resectable HCC, whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. PVTT has been certified as an independent risk of early recurrence.

Although TACE has been used to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the STORM trial shows that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need.

At present, the PD-1 antibody has presented a promising and safe therapeutic result of unresectable HCC and provided good survival benefit for advanced HCC patients. Consistent with this, we proposed a hypothesis that a novel immunetherapy using the PD-1 antibody could suppress postoperative recurrence and prolong HCC patients survival period effectively.

Full description

Hepatic resection is the most effective curative treatment for resectable hepatocellular carcinoma (HCC), whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. Portal vein tumor thrombus (PVTT) has been certified as an independent risk of early recurrence (≤2years after hepatic resection).

Although Transarterial Chemoembolization (TACE) has been used as an effective local adjuvant treatment to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the double blind randomized STORM trial shows a negative result that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

HCC comfirmed by postoperative histology examination
PVTT comfirmed by postoperative histology examination
None other type of malignant tumors
None intra or extra-hepatic recurrence postoperative adjuvant therapy
Child-pugh grade A or B liver function
None other organ dysfunction

Exclusion criteria

Combined with other type of malignant tumors
Presence of intra or extra-hepatic recurrence
Child-pugh grade C liver function
Combined with other organ dysfunction

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

PD-1 antibody group

Experimental group

Description:

In this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days.

Treatment:

Drug: PD-1 antibody

Controlled group

Active Comparator group

Description:

In this group entrolled patients were treated with TACE in the 30 days after hepatic resection.

Treatment:

Procedure: TACE