Study of the Combination of TACE With Apatinib in Patients With Hepatocellular Carcinoma

NCT03066557 | Unknown DMC

• 1 other identifier: ANIMATE-JS-201
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. The treatment of advanced HCC still has a long way to go. At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC are ongoing. Based on our important discovery of previous clinical studies, we intend to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Apatinib

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

  2 years

Secondary Outcomes (5)

• TTP

  2 years

• OS

  2 years

• DCR

  2 years

• ORR

  2 years

• QoL

  2 years

Study Arms (2)

study group

ACTIVE COMPARATOR

TACE and Apatinib

Procedure: TACE and Apatinib

control group

EXPERIMENTAL

TACE alone

Procedure: TACE

Interventions

TACE and Apatinib PROCEDURE

TACE and Apatinib 250mg po qd

Also known as: Aitan

study group

TACE PROCEDURE

TACE

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 - 75 years old;
• Must be strictly in accordance with the "guidelines for primary liver cancer diagnosis and treatment" (2011 edition). According to clinical diagnosis standard or confirmed by histopathology or cytology, the patients with advanced primary liver cancer who can't be?removed surgically, and can't accept palliative surgery or radiation therapy, and have at least one measurable lesions;The biggest tumor 10 cm or less;
• Refuse the treatment of sorafenib;
• The Child - Pugh( liver function grade): grade A or better grade of B (≤7 points);
• BCLC stage for B or C;
• Within 1 week before into the study,ECOG PS0-1;
• The expected lifetime of patients should be equal to or more than 12 weeks;
• The main viscera function of patients must be normal, and should meet the following requirements:
• Blood routine examination must meet: HB≥90 g/L, ANC≥1.5×10\^9/L, PLT≥60×10\^9/L;
• Biochemical examination should meet the following criteria: ALB ≥29 g/L, ALT and AST\<5xULN, TBIL ≤1.5xULN, creatinine≤1.5xULN (Only one of albumin and bilirubin can be 2 points in the rating of Child-Pugh);
• The patients are willing to join in this study, and have signed the informed consent. The patients have good adherence, and are willing to cooperate with the follow-up.

You may not qualify if:

• Patients have received radiotherapy or chemotherapy within four weeks before the study;
• In the past (within 5 years) or at the same time,patients were diagnosed with other malignant tumor which have not been cured. As for skin basal cell carcinoma and cervical carcinoma in situ,they can be excepted;
• Patients who are diagnosed with hypertension which cant be reduced to normal range via antihypertensive drug treatment(systolic blood pressure\> 140 mmHg / diastolic blood pressure\> 90 mmHg);
• Patients who are diagnosed with II or higher level of myocardial ischemia, myocardial infarction, uncontrolled arrhythmia(including QTc interval prolongation men\> 450 ms, female\> 470 ms);
• There are many factors which can influence the oral drug absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction, which can significantly affect the drug taking and absorption);
• Within 6 months in the past,the patients have a history of gastrointestinal bleeding or a gastrointestinal bleeding tendency, for example,there is a risk of bleeding of esophageal varicose veins, local active ulcerative lesions, defecate occult blood ≥ (+ +)(+) shall not be admitted into the study;
• within 28 days before being admitted into the study, there is abdominal fistula, gastrointestinal perforation or abdominal abscess;
• Blood coagulation function is abnormal (INR\>1.5 or PT\> ULN+4s), and the patients are able to be faced with a bleeding tendency or being treated with thrombolysis and anticoagulation;
• Has been diagnosed with ?the central nervous system metastases or the brain metastases has been known;
• There are past medical history or history of present illness of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia,pulmonary function test suggests there is objective evidence of severely damaged lung function;
• Urine routine inspection suggests that the urine protein ≥++;24 hours urine protein examination\>1.0 g;
• Within 7 days before being admitted into the study,patients have received a potent CYP3A4 inhibitor treatment, or within 12 days before being admitted into the study,patients have received potent CYP3A4 inducers treatment;
• Pregnant or lactating women;Patients with fertility are unwilling or unable to take effective contraceptive measures;
• With a mental illness, or has a history of psychiatric drugs abuse;
• Patients with HIV infection.

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Feng Jifeng, Doctor

  Jiangsu Cancer Institute & Hospital

  STUDY CHAIR

Central Study Contacts

Chen Shixi, Bachelor

CONTACT

+86-13505192984; chenshixi2007@126.com

Yin Guowen

CONTACT

+86-13951841177; jsnjygw@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of department

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 28, 2017
• Study Start: March 15, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: February 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share