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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03914352
Enrollment
40
Registered
2019-04-16
Start date
2019-04-01
Completion date
2020-01-31
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, Portal vein tumor thrombus, Hepatic resection, Recurrence, PD-1 antibody

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.

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. 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.

Interventions

DRUGPD-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.

PROCEDURETACE

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

Sponsors

Cancer Hospital of Guangxi Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival5 yearsCumulative survival period after hepatic resection
Disease-free survival5 yearsCumulative none recurrence survival period after hepatic resection

Countries

China

Contacts

Primary ContactJiazhou Ye, M.D.
87066160@qq.com+86 13367719078
Backup ContactLequn Li, M.D.
lequn_li001@163.com+86 07715310045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026