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Adjuvant Therapy With Apatinib for HCC Patients With PVTT Who Underwent Radical Resection

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ClinicalTrials.gov Identifier: NCT03261791
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
In this phase 2 study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for hepatocellular carcinoma with portal vein tumor thrombus.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Apatinib Phase 2

Detailed Description:
Portal vein tumor thrombus (PVTT) is one of the characteristics of advanced stage for patients with hepatocellular carcinoma (HCC). There's limited treatment choice for these patients. Even for those who underwent curative resection (R0 resection), the recurrence rate was extremely high. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently, which had been proven effective in many solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor receptor. Phase 2 study of apatinib for patients with advanced HCC had shown signals of clinical efficacy and modest safety. In this study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for HCC with PVTT.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Exploratory Study of Apatinib Adjuvant Therapy for Hepatocellular Carcinoma With Portal Vein Invasion Who Underwent Radical Resection
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : April 20, 2020

Arm Intervention/treatment
Experimental: Apatinib
Apatinib mesylate tablets 500 mg po qd.
Drug: Apatinib
Apatinib mesylate tablets 500 mg po qd.




Primary Outcome Measures :
  1. recurrence-free survival [ Time Frame: 24 months ]
    From the date of liver surgery to the date of diagnosis of tumor recurrence


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 24 months ]
    From the date of liver surgery to the date of death

  2. safety: the potential side effects [ Time Frame: 24 months ]
    The potential side effects



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged from 18-70 years.
  2. HCC diagnosis confirmed by pathological examination who did not receive anti-tumor treatment (anti-tumor treatment including but not limited to: local ablation therapy, TACE, radiation therapy, chemotherapy, targeted drug therapy, etc.)
  3. Underwent radical resection for hepatocellular carcinoma with portal vein tumor thrombus, as assessed by preoperative imaging or intraoperative findings, within 4 weeks
  4. Child-Pugh class: A or B7
  5. The ECOG: 0-1 points
  6. The expected survival time ≥ 6 months.
  7. Main organs function is normal including:

    • blood routine examination

      • HB ≥ 90 g/L
      • ANC ≥ 1.5×109 /L
      • PLT ≥ 80×109/L
    • biochemical test

      • ALB ≥ 29 g/L
      • ALT<3 ULN and AST< 3 ULN
      • TBIL ≤ 1.5 ULN
      • Serum creatinine ≤ 1.5 ULN;
  8. Women of childbearing age must have pregnancy tests (serum or urine) within 7 days prior to admission, and the results are negative and are willing to use appropriate methods of contraception at 8 weeks after the trial and at the end of the test. For men, surgical sterilization should be applied, or consent to the appropriate method of contraception 8 weeks after the trial and at the end of the trial;
  9. subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.

Exclusion Criteria:

  1. Hepatic duct carcinoma、mixed cell carcinoma and fiberboard layer cell carcinoma which have confirmed; Past (5 years) or current with other malignant tumor, except skin basal cell carcinoma and cervical carcinoma in situ.
  2. Patients with hypertension who are unable to fall within normal range by antihypertensive medications (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg).
  3. With the second level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 ms).
  4. Factors that affect oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect the use and absorption of drugs.
  5. Ascites with clinical symptoms requires therapeutic peritoneal paracentesis or drainage.
  6. In the past 6 months, with the history of alimentary tract hemorrhage or definite gastrointestinal bleeding tendency, such as: the risk of bleeding esophageal varices, local active ulcerative lesions, fecal occult blood; For those with fecal occult blood (+), gastroscopy is required.
  7. Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 28 days before entry;
  8. Postoperative complications were not relieved.
  9. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy;
  10. Past and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug associated pneumonia, and severe lung function impairment;
  11. Urine routine showed that urinary protein is more than + + or confirmed 24 hours urine protein is more than 1.0 g;
  12. Symptomatic metastasis of the central nervous system;
  13. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives;
  14. Patient with mental illness or a history of psychotropic substance abuse;
  15. HIV infection;
  16. Before operation, AFP or PIVKA-2 increased, but not decreased to normal range;
  17. HBV-DNA>10^3 copys/ml;
  18. Other conditions that the investigators considered that not unsuitable for inclusion.

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): NCT03261791


Contacts
Contact: Xiao-Dong Zhu +8602164037181 zhuxiaodong@gmail.com

Locations
China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 20032
Contact: Xiao-Dong Zhu, MD&PhD       zhuxiaodong@gmail.com   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Principal Investigator: Hui-CHuan Sun, MD&PhD Fudan University
Principal Investigator: Jia Fan, MD&PhD Fudan University

Additional Information:
Publications:
Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03261791     History of Changes
Other Study ID Numbers: APA- ZS-PVTT
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Zhongshan Hospital:
hepatocellular carcinoma
apatinib
portal vein invasion
adjuvant therapy
resection

Additional relevant MeSH terms:
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