A Trial to Compare Surgery With Sorafenib for Hepatic Celluler Cancer With Portal Vein Tumor Thrombosis

RCT Research: the Treatment of Hepatic Carcinoma With Portal Vein Branch Tumor Thrombosis (Resection or Sorafenib)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03178656

Enrollment

Registered

2017-06-07

Start date

2016-12-15

Completion date

2019-12-15

Last updated

2017-12-21

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

Conditions

Portal Vein Tumor Thrombus

Keywords

sorafenib, operation

Brief summary

According to the guidelines recommended, only a few new targeted therapy drugs treatment, such as Sorafenib, is proper. It's 3 year survival rate is only 8% or so. According to our previous study, patients with hepatic carcinoma without portal vein tumor thrombus backbone and the contralateral tumor thrombus applyed tumor excision, along with tumor thrombus, the 3 year survival rate can reach 39.9%, the 5-year survival rate can reach 22.7%, curative effect is obviously better.

Interventions

DRUGSorafenib

continuous application of the drugs

PROCEDUREsurgery

curative resection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 1\. Clinical diagnosis of Hepatic cellular Carcinoma. 2. Patients with Portal Vein Tumor Thrombus (PVTT) of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI. 3\. Patients with a solitary tumor or multiple tumor which are resectable. 4. Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis. 5\. Patients without surgical contraindication. 6. Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) \< 10% before treatment. 7\. Laboratory examination: haemoglobin (Hb)\>100g/L, white blood cell (WBC) \> 3000/mL, PLT \> 8×10\*10/L before treatment. 8\. Patients without severe esophagealgastric varices before treatment. 9. Patients with HBV，HBV DNA≤100, 000 copy/mL. 10. All of the patients has written consent for this research.

Exclusion criteria

* 1.Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis. 2.Patients with surgical contraindication. 3.Patients with Child C grade liver function before treatment. 4.Patients with other malignancy. 5.Patients treated with hepatic resection or TACE before this treatment. 6.Patients with severe esophagealgastric varices or refractory ascites or coagulation dysfunction before treatment.

Design outcomes

Primary

Measure	Time frame	Description
overall survival of 1 year	1 years	including 3, 6, and 12 months overall survival (OS) rate
overall survival of 3 year	3 years	including 1, 2, and 3 years overall survival (OS) rate

Secondary

Measure	Time frame	Description
time to progression	3 years	deterioration indicated by complications or metastasis detected by CT, MRI and laboratory examination.

Other

Measure	Time frame	Description
mortality	30 days	death within 30 days after surgery

Countries

China

Contacts

Primary ContactQiong Gong, Doctor

dtjgq486@hust.edu.cn+8618086496360

Backup ContactXiaoping Chen, Doctor

chenxp@medmail.com.cn+862783665253

Outcome results

None listed

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