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Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC) (2011PTAHCC)

Primary Purpose

Hepatectomy, Hepatocellular Carcinoma, Sorafenib

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

hepatic resection

transcatheter hepatic arterial chemoembolization

sorafenib

About this trial

This is an interventional treatment trial for Hepatectomy focused on measuring hepatocellular carcinoma, treatments, survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients > 18 years of age.
Diagnosed to have advanced HCC (BCLC C stage).
Patients who have a life expectancy of at least 12 weeks.
Patients whose primary tumor can be resected.

Definition of resectable in this study:

Tumor number <=2.
If number of tumors >= 3, then all tumors were located in the same lobe.
Without tumor invasion of the main trunk of the portal vein, or hepatic duct, or caval vein.
Hepatocellular carcinoma with histological diagnose or clinical diagnose according to AASLD.
No major post-operative complication.
Patients who have an ECOG PS of 0, or 1.
Cirrhotic status of Child-Pugh class A only.
The following laboratory parameters:

Platelet count > 60 x 109/L Hemoglobin > 8.5 g/dL Albumin > 3.5 g/dL Total bilirubin < 25μmol/L Alanine transaminase (ALT) and AST < 2.5 x upper limit of normal Serum creatinine <1.5 x the upper limit of normal Prothrombin time (PT)<3 seconds above control.

• Patients who give written informed consent.

Exclusion Criteria:

Previous or concurrent cancer that is distinct in primary site or histology from HCC.
History of cardiac disease.
Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Known history of human immunodeficiency virus (HIV) infection
Known Central Nervous System tumors including metastatic brain disease.
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
History of organ allograft.
Known or suspected allergy to the investigational agent or any agent given in association with this trial.
Pregnant or breast-feeding patients.
Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
Excluded therapies and medications, previous and concomitant: Systemic chemotherapy and target drug other than sorafenib. Antiviral treatment is allowed.
Radiotherapy except for which done for bone metastases palliatively.

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

A, surgery

B, TACE

C, sorafenib

Arm Description

The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy.

Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy.

Patients in group C will receive monotherapy of sorafenib.

Outcomes

Primary Outcome Measures

Overall survival (OS)

defined as the time from the first treatment to death

Secondary Outcome Measures

Progression Free Survival (PFS)

defined as the time from the first treatment to the first progression disease is confirmed by radiological methods

AEs and SAEs

according to CTC AE 3.0

cost of treatments

to compare costs of different treatments

Full Information

NCT ID

NCT01409499

First Posted

August 1, 2011

Last Updated

September 9, 2018

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01409499

Brief Title

Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)

Acronym

2011PTAHCC

Official Title

A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

January 2011 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The standard treatment choice for advanced hepatocellular carcinoma (HCC) is sorafenib, and its efficacy is limited. More active treatments were performed in patients with advanced HCC in China, which include radical hepatectomy or TACE. The study is to investigate whether the active treatment will profit survival of patients, and to evaluate the safety.

Detailed Description

This is a prospective non-randomized controlled study. Patients with advanced hepatocellular carcinoma (BCLC C stage) who underwent palliative resection or TACE followed with Sorafenib or treated by sorafenib alone will be included. The patients will be divided to group A (palliative resection plus sorafenib), group B (palliative TACE plus sorafenib), and group C (sorafenib alone). The sample size will be about 200 cases altogether.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatectomy, Hepatocellular Carcinoma, Sorafenib

Keywords

hepatocellular carcinoma, treatments, survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A, surgery

Arm Type

Experimental

Arm Description

The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy.

Arm Title

B, TACE

Arm Type

Experimental

Arm Description

Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy.

Arm Title

C, sorafenib

Arm Type

Experimental

Arm Description

Patients in group C will receive monotherapy of sorafenib.

Intervention Type

Procedure

Intervention Name(s)

hepatic resection

Other Intervention Name(s)

Group A (hepatectomy)

Intervention Description

palliative hepatectomy followed by sorafenib

Intervention Type

Procedure

Intervention Name(s)

transcatheter hepatic arterial chemoembolization

Other Intervention Name(s)

Group B (TACE)

Intervention Description

TACE followed by sorafenib

Intervention Type

Drug

Intervention Name(s)

sorafenib

Other Intervention Name(s)

Group C (sorafenib)

Intervention Description

sorafenib monotherapy, 400mg Bid, continuously

Primary Outcome Measure Information:

Title

Overall survival (OS)

Description

defined as the time from the first treatment to death

Time Frame

anticipate 6-12 months

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

defined as the time from the first treatment to the first progression disease is confirmed by radiological methods

Time Frame

anticipate 3-6 months

Title

AEs and SAEs

Description

according to CTC AE 3.0

Time Frame

anticipate 6-12 months

Title

cost of treatments

Description

to compare costs of different treatments

Time Frame

3 months in average

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients > 18 years of age. Diagnosed to have advanced HCC (BCLC C stage). Patients who have a life expectancy of at least 12 weeks. Patients whose primary tumor can be resected. Definition of resectable in this study: Tumor number <=2. If number of tumors >= 3, then all tumors were located in the same lobe. Without tumor invasion of the main trunk of the portal vein, or hepatic duct, or caval vein. Hepatocellular carcinoma with histological diagnose or clinical diagnose according to AASLD. No major post-operative complication. Patients who have an ECOG PS of 0, or 1. Cirrhotic status of Child-Pugh class A only. The following laboratory parameters: Platelet count > 60 x 109/L Hemoglobin > 8.5 g/dL Albumin > 3.5 g/dL Total bilirubin < 25μmol/L Alanine transaminase (ALT) and AST < 2.5 x upper limit of normal Serum creatinine <1.5 x the upper limit of normal Prothrombin time (PT)<3 seconds above control. • Patients who give written informed consent. Exclusion Criteria: Previous or concurrent cancer that is distinct in primary site or histology from HCC. History of cardiac disease. Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) Known history of human immunodeficiency virus (HIV) infection Known Central Nervous System tumors including metastatic brain disease. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. History of organ allograft. Known or suspected allergy to the investigational agent or any agent given in association with this trial. Pregnant or breast-feeding patients. Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. Excluded therapies and medications, previous and concomitant: Systemic chemotherapy and target drug other than sorafenib. Antiviral treatment is allowed. Radiotherapy except for which done for bone metastases palliatively.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minshan Chen, M.D.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)

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