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Carcinoma, HepatocellularPhase 2NCT03261791

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

A Phase 2 study testing Apatinib in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
20 Jul 2017to 20 Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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；
  • 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;
  • subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.

Who cannot join

  • 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.
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  • 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;
  • Before operation, AFP or PIVKA-2 increased, but not decreased to normal range;
  • HBV-DNA>10^3 copys/ml；
  • Other conditions that the investigators considered that not unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Xiao-Dong Zhu contact

+8602164037181

zhuxiaodong@gmail.com

China1 site, 1 recruiting

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 20032

    Xiao-Dong Zhu, MD&PhD, zhuxiaodong@gmail.com

    Recruiting

Other trials in China

About this study

Official title: A Exploratory Study of Apatinib Adjuvant Therapy for Hepatocellular Carcinoma With Portal Vein Invasion Who Underwent Radical Resection

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.

Read the 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.

Being tested
Apatinib
Keywords
hepatocellular carcinoma, apatinib, portal vein invasion, adjuvant therapy, resection
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    Apatinib mesylate tablets 500 mg po qd.

Study groups in NCT03261791
Study groupRoleWhat they receive
ApatinibExperimentalApatinib mesylate tablets 500 mg po qd.
Receives: Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recurrence-free survival

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

    Measured: 24 months

Secondary outcomes (2)

  1. overall survival

    From the date of liver surgery to the date of death

    Measured: 24 months

  2. safety: the potential side effects

    The potential side effects

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start20 Jul 2017
  3. Primary completion20 Jan 2020 (estimated)
  4. Study completion20 Apr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03261791
Sponsor's protocol ID
APA- ZS-PVTT
Status last verified
Aug 2017
First submitted
23 Aug 2017
Last updated
25 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26026424

  • 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.

    PubMed 20827404

  • 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.

    PubMed 33209881

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiao-Dong Zhu (+8602164037181, zhuxiaodong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recurrence-free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03261791, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.

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