Study of Apatinib Combined With TACE in Advance Hepatocellular Carcinoma (HCC)

the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with advanced HCC

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: TACE; Drug: Apatinib

Detailed Description

HCC The is a common malignancy in the world, especially in China. Advanced HCC treatment is difficult and the prognosis is poor, which is still a great challenge and threat to the medical profession. The advent of the molecular targeted drug, Sola, has made the treatment dilemma of advanced HCC a breakthrough, but the efficacy and economic health ratio is far from satisfactory. After Sola, many new molecular targeted drugs were studied, but failed.

Although multiple treatment options, but for HCC Patient-recommended treatment programs require systematic treatment and surgery, TACE , local ablation and radiotherapy and other multidisciplinary means of combination, the selection of appropriate patients, appropriate means and timing to achieve individualized treatment.

1. Aptinib Union TACE can be generated through embolization and angiogenesis by the dual target of vascular suppression;2. TACE induces hypoxia, leading to an increase in the number of hypoxia-inducing factors that increases VEGF and PDGFR , while VEGF the and PDGFR may be important factors that induce tumor recurrence by stimulating tumor angiogenesis.

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haipeng Yu, MD; Phone Number: 13352070835; Email: jieruke@yahoo.com.cn
• Study Contact Backup: Name: Zhi Guo, MD; Phone Number: 18622221211; Email: cjr.guozhi@vip.163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Hospital
      • Contact: Haipeng Yu, MD; Phone Number: 13352070835; Email: jieruke@yahoo.com.cn
      • Sub-Investigator: Wenge Xing, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: 18-70 years old;
2. initial treatment diagnosed by histopathological or cytological examination BCLC Staging B/C Hepatocellular carcinoma of the liver ( HCC ) and at least one of the largest tumors in measurable lesions ≤15cm ;
3. Child-pugh liver function Rating: A level, B level;
4. BCLC Staging as B / C period;

5. before join in the group 1 weeks ECOG PS Rating: 0-1 score; estimated Lifetime ≥12 Week; Lab metrics meet the following criteria: ( 1 ) Blood routine check:

   1. HB≥90 g/L;
   2. ANC≥1.5x109/L;
   3. PLT≥60x109/L; ( 2 ) Biochemical Examination:
   1. ALB≥29 g/L;
   2. ALT and AST<2.5*ULN;
   3. TBIL ≤ 2*ULN;
   4. Cr ≤ 1.5*ULN;
6. women of childbearing age must be pregnancy tests before join in the group in 7 days;
7. Participants volunteered to join this study should sign informed consent, with good compliance and follow-up.

Exclusion Criteria:

1. Central hepatic artery / hepatic venous fistula in patients with hepatocellular carcinoma, diffuse liver cancer patients, with large vascular invasion of liver cancer patients (including portal vein tumor thrombus);
2. 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;
3. clinically symptomatic ascites that requires therapeutic celiac puncture or drainage with high blood pressure and cannot be reduced to normal range by anti hypertensive medications (systolic pressure > 140 mmHg , diastolic pressure >90 mmHg );
4. Suffering Ⅱ above-level myocardial ischemia or myocardial infarction, control of poor arrhythmia (including QTC inter-phase male ≥450 ms , female ≥470 ms );
5. Follow NYHA Standard Ⅲ ~ Ⅳ grade heart insufficiency or heart color Doppler ultrasonography: LVEF (left ventricular ejection fraction) < 50% ;
6. There are various factors affecting oral medication (e.g.inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption);
7. previous within 6 months there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: bleeding risk of esophageal varices, local active ulcer lesions, fecal occult blood ≥ ( ++ ) not in group; fecal occult blood (+ ), requiring gastroscopy;
8. before participating in this study There were abdominal fistula, gastrointestinal perforation or celiac abscess in the day;
9. Coagulation dysfunction ( INR > 1.5 or prothrombin time ( PT ) > ULN+4 seconds), with bleeding tendencies or undergoing thrombolysis or anticoagulant therapy;
10. patients who have undergone central nervous system metastasis or known brain metastases;
11. patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment;
12. urine proteins are routinely shown ≥++ or confirmed 24 hour urine protein ration > 1.0 g ;
13. before participating in the study 7 days use strong-effect in CYP3A4 inhibitor therapy, or prior to participating in the study 12 days use the strong-effect in CYP3A4 inducer Therapy;
14. pregnant or lactating women who are not willing or unable to take effective contraceptive measures;
15. A history of mental illness, or psychotropic substance abuse;
16. Union HIV infected patients;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apatinib combined with TACE; patients received Aptinib, 250 mg daily after TACE treatment, for 4-6 weeks	Procedure: TACE; epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles.; Other Names: chemoemtranscatherer arterial bolization; Drug: Apatinib; a molecular targeted anti-tumor drugs,small molecule vascular endothelial growth factor receptor 2 inhibitor; Other Names: ai tan
Placebo Comparator: chemoemtranscatherer arterial bolization; epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles.	Drug: Apatinib; a molecular targeted anti-tumor drugs,small molecule vascular endothelial growth factor receptor 2 inhibitor; Other Names: ai tan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression free survival	one and a half year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	one and a half year
TTP	time to progression	one and a half year
DCR	disease control rate	one and a half year
ORR	objective response rate	one and a half year
QOL	number of participants with treatment-related adverse events as assessed by EORTC QLQ-C30	one and a half year

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Study Chair: Zhi Guo, MD, Tianjin Medical University Cancer Institute & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: January 7, 2018
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Apatinib; advanced hepatocellular carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: Ahead-HBH001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No