Apatinib Combined With Capecitabine Compared With Apatinib Treat Advanced Hepatocellular Carcinoma

May 12, 2017 updated by: Zeng Zhiming, First Affiliated Hospital of Guangxi Medical University

Apatinib Combined With Capecitabine Compared With Apatinib in the Treatment of Advanced Non-resectable Hepatocellular Carcinoma

It is an open,randomized,controlled study, and the purpose of this study is to observe and evaluate the efficacy and safety of Apatinib combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is the clinical study of Apatinib combined with Capecitabine compared with Apatinib in the treatment of advanced non-resectable Hepatocellular Carcinoma, the object is patients with advanced hepatocellular carcinoma,its purpose is to observe and evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with Capecitabine in the treatment of patients with advanced hepatocellular carcinoma, its main primary endpoint is TTP (time to progression) while the secondary endpoint is OS (overall survival), ORR (objective response rate), DCR (disease control rate), serum alpha-fetoprotein (AFP) levels and quality of life. 170 patients will be enrolled and 1:1 randomized into two groups: Apatinib combined Capecitabine and Apatinib alone. Major safety indicators are Vital signs, laboratory indicators, adverse events (AE), serious adverse events (SAE), drug-related AE and SAE, and specific AE (such as hypertension, proteinuria, and hand-foot syndrome), according to NCI-CTCAE.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

.Inclusion Criteria:

  • Age: ≥18-75 years old
  • Recurrent / Metastatic non-resectable HCC patients who are in strict compliance with clinical diagnostic criteria of the Standard of Primary Liver Cancer Diagnosis and Treatment (2011 edition) or diagnosis by histopathology or cytology, and are unable to accept palliative surgery or radiotherapy, and have at least one measurable lesion (according to mRECIST, the measurable lesions spiral CT scan length ≥ 10mm or enlarged lymph node diameter ≥ 15mm); the largest tumor ≤ 10cm
  • Child-Pugh liver function rating: A or better B (≤ 7 points)
  • BCLC stage is B-C period
  • ECOG PS score within 1 week before enrollment: 0-1 points
  • Expected survival time ≥12 weeks
  • The main organs function is normal, that is, meeting the following criteria:

Blood examination:

HB ≥ 90 g / L; ANC ≥ 1.5 × 109 / L; PLT ≥ 60 × 109 / L;

Biochemical examination:

ALB ≥ 29 g / L; ALT and AST < 2.5 ULN; TBIL ≤ 2ULN; Creatinine ≤ 1.5ULN; (Albumin and bilirubin two indicators can only have one for 2 points in Child-Pugh rating)

  • Women of childbearing age shall undergo pregnancy tests within 7 days before enrollment

  • People to be tested are volunteered to join the study and sign informed consent. They should have good compliance and are easy to follow-up

    .Exclusion Criteria:

  • Patients with hepatic cholangiocarcinoma or mixed cell carcinoma or fibrous lamellar cell carcinoma; or at the same time with other untreated malignant tumors in the past (within 5 years), except for cured skin basal cell carcinoma and cervical carcinoma in situ
  • Patients who are preparing for liver transplantation (except those who have undergone liver transplantation)
  • Patients with high blood pressure, and it can't be reduced to normal range (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) by antihypertensive drug therapy
  • Patients with level two or above myocardial ischemia or myocardial infarction, or poor controlled arrhythmia (including QTc interval men ≥ 450 ms, female ≥ 470 ms)
  • According to NYHA standard Ⅲ ~ Ⅳ grade cardiac insufficiency or cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) <50%
  • Have a variety of factors affecting oral drugs (such as can not swallow, chronic diarrhea and intestinal obstruction, significantly affect drug taking and absorption)
  • There is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding in the past 6 months, such as: esophageal varicose veins with bleeding risk, local active ulcer lesions. Fecal occult blood ≥ (++) can not be grouped, if fecal occult blood (+),endoscopy is required
  • Abdominal fistula, gastrointestinal perforation or abdominal abscess appeared within 28 days of participating in the study
  • Coagulation dysfunction (INR> 1.5 or prothrombin time (PT)> ULN + 4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy
  • Patients with central nervous system metastasis or brain metastases
  • Patients who is suffering or had suffered pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function
  • Urine test indicated urine protein ≥ ++ or confirmed 24 hours urine protein> 1.0 g
  • A strong CYP3A4 inhibitor treatment was received within 7 days before the study, or a strong CYP3A4 inducer was received within 12 days before the study
  • Pregnant or lactating women; fertility patients who are reluctant or unable to take effective contraceptive measures
  • Patients with mental illness, or history of mental drug abuse
  • Patients with bone metastases had received palliative radiotherapy (radiotherapy area> 5% bone marrow area) within 4 weeks before participating in the study
  • Patients who are joint with HIV infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Apatinib Combined with Capecitabine
Apatinib,500mg,once a day, orally (after breakfast),from day 1 to day 21 (including day 21) for continuous administration, every 21 days for one cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group; Capecitabine,1000mg/m2,twice a day (at intervals of 12 hours,equivalent to a total daily dose of 2000 mg / m2),orally,sustained 14 days, off for 7 days, every 21 days for a cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group.
Drug: Capecitabine
Capecitabine 1000mg/m2 po bid, d1-d14, every 21 days for a cycle;
Other Names:
  • Aibin
Drug: Apatinib
Apatinib 500 mg po qd, d1-d21, every 21 days for one cycle
Other Names:
  • Aitan
Active Comparator: Apatinib
Apatinib,500mg,once a day, orally (after breakfast),from day 1 to day 21 (including day 21) for continuous administration, every 21 days for one cycle. If after two dose adjustments, the subject still can not tolerate toxicity, he or she should be out of group;
Drug: Apatinib
Apatinib 500 mg po qd, d1-d21, every 21 days for one cycle
Other Names:
  • Aitan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
time to progression
Time Frame: through study completion, an average of 2 years
From the randomization to the time of tumor progression
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Guangxi Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhiming Zeng, Master, Guangxi Medical University First Affiliated Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRGX-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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