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Study of Apatinib After Systemic Therapy in Patients With Hepatocellular Carcinoma(AHELP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329860
Recruitment Status : Completed
First Posted : January 1, 2015
Results First Posted : January 22, 2024
Last Update Posted : January 22, 2024
Sponsor:
Collaborator:
NanJing PLA 81 Hospital
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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Brief Summary:

This was a multicenter, randomized, double-blind, phase III trial. This clinical study evaluates the efficacy and safety of Apatinib in patients with advanced liver cancer who have progressed on Systemic Therapy (Chemotherapy and/or Targeted Therapy).

Approximately 400 patients who meet the entry criteria will be randomly assigned in a 2:1 ratio to Apatinib or placebo (1/3 chance to receive placebo).

Primary endpoint of the study is overall survival.


Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Apatinib Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study (AHELP) of Apatinib in Patients With Hepatocellular Carcinoma After Systemic Therapy（Chemotherapy and/or Targeted Therapy）
Actual Study Start Date : March 26, 2014
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : August 14, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Apatinib
750 mg orally (p.o.) every day (qd), 28 days as one cycle
 Drug: Apatinib
Placebo Comparator: Placebo
orally (p.o.) every day (qd), 28 days as one cycle
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Approximately 36 months ]

Secondary Outcome Measures :
  1. Time to Progression（TTP） [ Time Frame: Approximately 36 months ]
  2. Progression Free Survival (PFS) [ Time Frame: Approximately 36 months ]
  3. Objective Response Rate [ Time Frame: Approximately 36 months ]
  4. Disease Control Rate [ Time Frame: Approximately 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 18 years old.
  2. Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC (hepatocellular carcinoma) who cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation,and with at least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1.
  3. Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy (Failure is defined as documented radiological progression according to the radiology charter. Intolerance is defined as ≥ grade 4 hematologic toxicities, ≥ grade 3 non-hematologic toxicities ≥ grade 2 heart, liver or kidney damage).
  4. Systemic therapy must have been completed ≥2 weeks before randomization (AEs due to prior treatment ≤ grade 1).
  5. Liver function status Child-Pugh Class A or B (score≤7).
  6. Barcelona Clinic Liver Cancer stage Category B or C.
  7. Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
  8. Life expectancy of at least 12 weeks.
  9. HBV DNA ≤ 2000IU/ml or 1×10E+4 copy/ml.

  10. Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted within 1 week before randomization.

    HB ≥ 90g/L; ANC≥1.5×10E+9/L; PLT≥80×10E+9/L; ALB ≥ 29g/L; ALT and AST < 5×ULN; TBIL ≤1.5×ULN; Cr ≤1.5×ULN

  11. Women of childbearing potential and men must agree to use adequate contraception .

Exclusion Criteria:

  1. Any local treatment (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks of randomization.
  2. Known hepatic duct carcinoma, mixed cell carcinoma or fibrolamellar hepatocellular carcinoma, known history or suffering from other cancer(except of cured skin basal cell carcinoma or carcinoma in situ of cervix).
  3. Patients who will receive liver transplantation.
  4. Ascites with clinical symptoms, i.e. require Abdominal paracentesis or drainage treatment such as or Child-Pugh Score>2.
  5. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
  6. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female≥ 470 ms).
  7. Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.
  8. Factors to affect oral administration（such as Patients unable to swallow oral medications, chronic diarrhea and ileus etc. situations evidently affect drug oral medication and absorption）.
  9. Previous digestive tract bleeding history within 6 months or evident gastrointestinal bleeding tendency, such as,：Esophageal varices with bleeding risk, local active ulcerative lesions, fecal occult blood≥（++）；if fecal occult blood（+），gastroscope check is required.
  10. The Within 28 days ahead of randomization, experience abdomen fistula, gastrointestinal perforation, or abdominal abscess
  11. Coagulation abnormalities (INR > 1.5 x ULN, or PT > ULN +4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
  12. Occurrence of central nervous system metastatic or known brain metastatic;
  13. Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.
  14. Proteinuria ≥ (++) or 24 hours total urine protein > 1.0 g.
  15. Received powerful inhibitor of CYP3A4 within 7 days or powerful inducer of CYP3A4 within 12 days before randomization.
  16. Pregnant or breast-feeding women; patients with fertility will not or there is no way to adopt effective contraceptive measures.
  17. Mental disorders history, or Psychotropic drug abuse history.
  18. Patients who has bone metastasis, has received Palliative radiotherapy (radiotherapy area > 5% marrow area).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329860


Locations
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China, Jiangsu
Jiangsu hengrui medicine CO. LTD
Lianyungang, Jiangsu, China, 222047
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
NanJing PLA 81 Hospital
  Study Documents (Full-Text)

Documents provided by Jiangsu HengRui Medicine Co., Ltd.:
Study Protocol  [PDF] March 10, 2017
Statistical Analysis Plan  [PDF] July 18, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02329860    
Other Study ID Numbers: APTN-III-HCC
First Posted: January 1, 2015    Key Record Dates
Results First Posted: January 22, 2024
Last Update Posted: January 22, 2024
Last Verified: July 2017
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action