NCT03261791

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

August 23, 2017

Last Update Submit

August 24, 2017

Conditions

Carcinoma, Hepatocellular

Keywords

hepatocellular carcinomaapatinibportal vein invasionadjuvant therapyresection

Outcome Measures

Primary Outcomes (1)

  • recurrence-free survival

    From the date of liver surgery to the date of diagnosis of tumor recurrence

    24 months

Secondary Outcomes (2)

  • overall survival

    24 months

  • safety: the potential side effects

    24 months

Study Arms (1)

Apatinib

EXPERIMENTAL

Apatinib mesylate tablets 500 mg po qd.

Drug: Apatinib

Interventions

ApatinibDRUG

Apatinib mesylate tablets 500 mg po qd.

Apatinib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged from 18-70 years.
  • 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.)
  • Underwent radical resection for hepatocellular carcinoma with portal vein tumor thrombus, as assessed by preoperative imaging or intraoperative findings, within 4 weeks
  • Child-Pugh class: A or B7
  • The ECOG: 0-1 points
  • The expected survival time ≥ 6 months.
  • 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
  • +3 more criteria

You may not qualify if:

  • 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.
  • Patients with hypertension who are unable to fall within normal range by antihypertensive medications (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg).
  • With the second level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 ms).
  • Factors that affect oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect the use and absorption of drugs.
  • Ascites with clinical symptoms requires therapeutic peritoneal paracentesis or drainage.
  • 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.
  • Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 28 days before entry;
  • Postoperative complications were not relieved.
  • Abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy;
  • Past and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug associated pneumonia, and severe lung function impairment;
  • Urine routine showed that urinary protein is more than + + or confirmed 24 hours urine protein is more than 1.0 g;
  • Symptomatic metastasis of the central nervous system;
  • Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives;
  • Patient with mental illness or a history of psychotropic substance abuse;
  • HIV infection;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 20032, China

RECRUITING

Related Publications (3)

  • Zhang ZM, Lai EC, Zhang C, Yu HW, Liu Z, Wan BJ, Liu LM, Tian ZH, Deng H, Sun QH, Chen XP. The strategies for treating primary hepatocellular carcinoma with portal vein tumor thrombus. Int J Surg. 2015 Aug;20:8-16. doi: 10.1016/j.ijsu.2015.05.009. Epub 2015 May 27.

    PMID: 26026424BACKGROUND

  • Omata M, Lesmana LA, Tateishi R, Chen PJ, Lin SM, Yoshida H, Kudo M, Lee JM, Choi BI, Poon RT, Shiina S, Cheng AL, Jia JD, Obi S, Han KH, Jafri W, Chow P, Lim SG, Chawla YK, Budihusodo U, Gani RA, Lesmana CR, Putranto TA, Liaw YF, Sarin SK. Asian Pacific Association for the Study of the Liver consensus recommendations on hepatocellular carcinoma. Hepatol Int. 2010 Mar 18;4(2):439-74. doi: 10.1007/s12072-010-9165-7.

    PMID: 20827404BACKGROUND

  • Sun HC, Zhu XD, Zhou J, Gao Q, Shi YH, Ding ZB, Huang C, Qiu SJ, Ren N, Shi GM, Sun J, Ye QH, Huang XW, Yang XR, Fan J. Adjuvant apatinib treatment after resection of hepatocellular carcinoma with portal vein tumor thrombosis: a phase II trial. Ann Transl Med. 2020 Oct;8(20):1301. doi: 10.21037/atm-20-6181.

    PMID: 33209881DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

apatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Hui-CHuan Sun, MD&PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

  • Jia Fan, MD&PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Dong Zhu

CONTACT

+8602164037181zhuxiaodong@gmail.com

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

August 23, 2017

First Posted

August 25, 2017

Study Start

July 20, 2017

Primary Completion

January 20, 2020

Study Completion

April 20, 2020

Last Updated

August 25, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)