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

Sponsor

Cancer Hospital of Guangxi Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03914352

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: PD-1 antibody Procedure: TACE	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of Hepatocellular Carcinoma Combined With Portal Vein Thrombus After Hepatic Resection

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Dec 30, 2019

Anticipated Study Completion Date :

Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PD-1 antibody group 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.	Drug: PD-1 antibody 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. Other Names: SHR-1210
Active Comparator: Controlled group In this group entrolled patients were treated with TACE in the 30 days after hepatic resection.	Procedure: TACE In this group enrolled patients were treated with TACE at the30 days after hepatic resection.

Arm

Intervention/Treatment

Experimental: PD-1 antibody group

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.

Drug: PD-1 antibody

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.

Other Names:

SHR-1210

Active Comparator: Controlled group

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

Procedure: TACE

In this group enrolled patients were treated with TACE at the30 days after hepatic resection.

Outcome Measures

Primary Outcome Measures

Overall survival [5 years]
Cumulative survival period after hepatic resection
Disease-free survival [5 years]
Cumulative none recurrence survival period after hepatic resection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Tumor Hospital of Guangxi Medical University	Nanning	Guangxi	China	530021

Sponsors and Collaborators

Cancer Hospital of Guangxi Medical University

Investigators

Study Chair: Lequn Li, M.D., Cancer Hospital of Guangxi Medical University
Principal Investigator: Jiazhou Ye, M.D., Cancer Hospital of Guangxi Medical University