Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma

NCT03510416 | Unknown Phase 2

• 1 other identifier: ZS-IR-2018
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization .

Conditions

Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization

Keywords

apatinib，TACE， hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Time To Progression

  Time to progression is defined as stable with treatment of apatinib combined with TACE after enrollment until lesions are defined as disease progression.

  From the date of first procedure of apatinib combined with TACE until the time when the disease progresses, assessed up to 14 months

Secondary Outcomes (1)

• Overall Survival

  From the date of randomization until the date of death from any cause, assessed up to 14 months

Study Arms (1)

apatinib combined with TACE

EXPERIMENTAL

Apatinib is administered after TACE 4-7 days, and TACE treatment is performed after discontinuation of apatinib for 4 days.Every 28 days is a cycle.

Drug: Apatinib; Radiation: TACE

Interventions

Apatinib DRUG

apatinib is a kind of Inhibitor of VEGFR-2

apatinib combined with TACE

TACE RADIATION

Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

apatinib combined with TACE

Eligibility Criteria

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

You may qualify if:

• Age: 18-70 years old;Estimated survival time≥12 weeks
• Histologicaly and cytologicaly diagnosed as Hepatocellular carcinoma of the liver ( HCC ) and with At least one imaging examination of measurable lesions (RECIST), CT or MR scan Long diameter of tumor ≥ 10 mm.Target lesion without Local treatment
• Child-pugh liver function Rating: A level, B level
• BCLC Staging as B / C period
• ECOG 0-1
• Have progressed after at least twice TACE
• The main organ function is normal, and meet the following standards:(1)The standard of blood routine examination should be consistent: HB≥90 g/L, ANC≥1.5×10\^9/L, PLT≥60×10\^9/L; (2)Biochemical tests should meet the following criteria: ALB ≥29 g/L；TBIL\<2'ULN, ALT and AST\<5'ULN,Cr ≤ 1.5\*ULN
• Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib
• Patients voluntarily entered the study and signed informed consent form (ICF).

You may not qualify if:

• Received Any local treatment other than TACE (including but not limited to surgery, radiotherapy, hepatic arterial embolization, hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within four weeks before randomization
• Participated in other cancer drug clinical trials within four weeks before randomization
• hepatobiliary cell carcinoma and mixed cell carcinoma are known; previous ( 5 year) or at the same time suffering from other incurable malignancies, except for the cured basal cell carcinoma of the skin and cervical carcinoma in situ
• have received or Prepared for liver transplantation
• A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; or Child-Pugh\>2；
• Patients with uncontrol hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite optimal drug therapy)
• Suffering from coronary heart disease, arrhythmia or grade II (including QTc prolongation \> 450 ms male, female, 470 MS) and Cardiac insufficiency
• According to NYHA standard, III \~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) \< 50%
• There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction
• Before randomization within 6 months had significant bleeding clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood and above, or suffering from vasculitis
• History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 28 days before randomization
• Abnormal coagulation (INR\>1.5 or PT\>ULN+4, or APTT\>1.5 ULN), bleeding tendency or receiving coagulation therapy
• Central nervous system with symptoms of metastasis
• there is typical interstitial pneumonia or pulmonary fibrosis
• Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Interventions

apatinib

Study Officials

• zhiping Yan, MD

  Department of Interventional Radiology, Zhongshan Hospital, Fudan University

  STUDY DIRECTOR

Central Study Contacts

zhiping Yan, MD

CONTACT

13681971205; yan.zhiping@zs-hospital.sh.cn

wei Zhang, MD

CONTACT

13917737593; zhang.wei6@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 27, 2018
• Study Start: May 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share