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Status unknownNCT03709953Spark-AL003Updated Oct 24, 2018

Efficacy and Safety of Apatinib as Third-line Therapy for Primary Pulmonary Lymphoepithelioid Carcinoma

A Phase 2 interventional study of Apatinib in Lung Carcinoma, sponsored by Guangzhou Institute of Respiratory Disease. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-24.

Sponsored by Guangzhou Institute of Respiratory Disease · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Currently, there is no standard treatment for primary pulmonary lymphoepithelioid carcinoma. Apatinib is a new kind of Vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitors (TKIs). A disease-control rate of 75% was found in lung cancer patients in a phase II clinical study. Therefore, researchers hope to explore the efficacy and safety of apatinib in the treatment of primary pulmonary lymphoepithelioid carcinoma.

Read the detailed description

This study is a prospective, exploratory clinical trial. The purpose of this study was to evaluate the efficacy and safety of apatinib monotherapy in the treatment of primary pulmonary lymphoepithelioid carcinoma.

Thirty-three cases of pulmonary lymphoepithelioid carcinoma were enrolled in this study.

The primary endpoint was median progression-free survival.

02

Conditions studied

  • Lung Carcinoma

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Keywords

  • apatinib
  • pulmonary lymphoepithelioid carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 33 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients aged from 18 to 75;
  • ECOG PS: 0 \~ 2 points;
  • lung lymphoepithelioid carcinoma;
  • Inoperable stage IV or stage III-B patients who had undergone second-line chemotherapy and had a measurable lesion (according to the RECIST 1.1 standard, the long diameter of the tumor lesion was 10mm in CT scan, the short diameter of the lymph node lesion was 15mm in CT scan, and the lesion was measured without local treatment such as radiotherapy and freezing).
  • Life expectancy ≥3 months;

  • the main organs are functioning normally:

    1. HB≥80 g/L(no blood transfusion within 14 days); ANC≥1.5×109 /L； PLT≥100×109 /L； WBC≥3×109 /L；
    2. TBIL≤1.5×ULN (upper limit of normal value); ALT and AST ≤2.5×ULN；
    3. creatinine ≤ 1.25 ULN; The clearance rate of creatinine ≥ 60mL/min.
    4. 24-hour urinary protein quantification \< 1.0g;
  • women of reproductive age (15 to 49 years old) must undergo a urinary pregnancy test within 7 days before starting treatment and the results must be negative. Women are willing to use appropriate methods of contraception;
  • Subjects signed the informed consent voluntarily.

Exclusion criteria

Exclusion Criteria:

  • Histologically proved to be other types of lung cancer, patients with nasopharyngeal lymphatic epithelial carcinoma with lung metastasis should be excluded.
  • Imperfection of upper gastrointestinal physiology, or absorption disorder syndrome, or inability to tolerate oral drugs, or active peptic ulcer;
  • Participated in other clinical trials within 4 weeks before the start of the study;
  • patients with hypertension who cannot control well through single antihypertensive medication (systolic blood pressure > 140mmhg, diastolic blood pressure > 90mmhg), myocardial ischemia or myocardial infarction, arrhythmia (including QT interval > 440 ms) or cardiac insufficiency;
  • Allergic to any ingredient in the drug;
  • Patients with abnormal coagulation function, receiving thrombolysis or anticoagulation therapy, bleeding tendency or have clear gastrointestinal bleeding concerns;
  • Hyperactive/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism occurred in 6 months before the start of the study;
  • Wound or fracture has not been healed for a long time;
  • urinary protein was greater than ++ and 24-hour urinary protein quantification >1.0 g.
  • Severe or uncontrolled infections;
  • Substance abuse or mental disorder;
  • Objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of pulmonary function;
  • Immunodeficiency, including being HIV-positive, or having other acquired, congenital immunodeficiency diseases, or having a history of organ transplantation;
  • Other malignant tumors within 5 years, except cured basal cell carcinoma of the skin and orthotopic carcinoma of the cervix;
  • Who have received VEGFR inhibitors, such as sorafenib and sunitinib, etc.;
  • pregnant or lactating women;
  • the researchers considered it unsuitable for inclusion.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (estimated)

Study arms

  • Experimental
    apatinib

    apatinib, 500 mg, po, QD; 28 days every cycle

    Drug: Apatinib

Interventions

  • DrugApatinib

    500 mg，po，QD； 28 days every cycle

    Also known as: Apatinib mesylate

06

What researchers measure

Primary outcomes

  1. PFS

    Median progression-free survival

    Time frame: 24 months

Secondary outcomes

  1. OS

    Median overall survival

    Time frame: 24 months

  2. ORR

    Objective Response Rate

    Time frame: 24 months

  3. DCR

    Disease control rate

    Time frame: 24 months

Other outcomes

  1. KPS

    Karnofsky Performance Scale

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Zhou Chengzhi
    Guangzhou, Guangdong 510120, China
    Recruiting
08

References and documents

Publications

  • Begin LR, Eskandari J, Joncas J, Panasci L. Epstein-Barr virus related lymphoepithelioma-like carcinoma of lung. J Surg Oncol. 1987 Dec;36(4):280-3. doi: 10.1002/jso.2930360413. PubMed 2826922 ↗
  • Ngan RK, Yip TT, Cheng WW, Chan JK, Cho WC, Ma VW, Wan KK, Au JS, Law CK. Clinical role of circulating Epstein-Barr virus DNA as a tumor marker in lymphoepithelioma-like carcinoma of the lung. Ann N Y Acad Sci. 2004 Jun;1022:263-70. doi: 10.1196/annals.1318.041. PubMed 15251971 ↗
  • Lin L, Lin T, Zeng B. Primary lymphoepithelioma-like carcinoma of the lung: An unusual cancer and clinical outcomes of 14 patients. Oncol Lett. 2017 Sep;14(3):3110-3116. doi: 10.3892/ol.2017.6510. Epub 2017 Jun 30. PubMed 28928848 ↗
  • Kim C, Rajan A, DeBrito PA, Giaccone G. Metastatic lymphoepithelioma-like carcinoma of the lung treated with nivolumab: a case report and focused review of literature. Transl Lung Cancer Res. 2016 Dec;5(6):720-726. doi: 10.21037/tlcr.2016.11.06. PubMed 28149767 ↗
  • Khokhar N, Nasir H, Amir M, Hassan S, Khan K, Ahmed M. Lymphoepithelioma-Like Carcinoma of the Esophagus: A Rare Tumor. J Coll Physicians Surg Pak. 2017 Sep;27(9):S114-S116. PubMed 28969745 ↗
  • Lin CY, Chen YJ, Hsieh MH, Wang CW, Fang YF. Advanced primary pulmonary lymphoepithelioma-like carcinoma: clinical manifestations, treatment, and outcome. J Thorac Dis. 2017 Jan;9(1):123-128. doi: 10.21037/jtd.2017.01.25. PubMed 28203414 ↗
  • Ooi GC, Ho JC, Khong PL, Wong MP, Lam WK, Tsang KW. Computed tomography characteristics of advanced primary pulmonary lymphoepithelioma-like carcinoma. Eur Radiol. 2003 Mar;13(3):522-6. doi: 10.1007/s00330-002-1535-7. Epub 2002 Jul 16. PubMed 12594554 ↗
  • Mo Y, Shen J, Zhang Y, Zheng L, Gao F, Liu L, Xie C. Primary lymphoepithelioma-like carcinoma of the lung: distinct computed tomography features and associated clinical outcomes. J Thorac Imaging. 2014 Jul;29(4):246-51. doi: 10.1097/RTI.0000000000000070. PubMed 24463405 ↗
  • Ma H, Wu Y, Lin Y, Cai Q, Ma G, Liang Y. Computed tomography characteristics of primary pulmonary lymphoepithelioma-like carcinoma in 41 patients. Eur J Radiol. 2013 Aug;82(8):1343-6. doi: 10.1016/j.ejrad.2013.02.006. Epub 2013 Mar 5. PubMed 23465736 ↗
  • Tian S, Quan H, Xie C, Guo H, Lu F, Xu Y, Li J, Lou L. YN968D1 is a novel and selective inhibitor of vascular endothelial growth factor receptor-2 tyrosine kinase with potent activity in vitro and in vivo. Cancer Sci. 2011 Jul;102(7):1374-80. doi: 10.1111/j.1349-7006.2011.01939.x. Epub 2011 May 9. PubMed 21443688 ↗
  • Jeong JH, Nguyen HK, Lee JE, Suh W. Therapeutic effect of apatinib-loaded nanoparticles on diabetes-induced retinal vascular leakage. Int J Nanomedicine. 2016 Jul 7;11:3101-9. doi: 10.2147/IJN.S108452. eCollection 2016. PubMed 27462154 ↗
  • Mi YJ, Liang YJ, Huang HB, Zhao HY, Wu CP, Wang F, Tao LY, Zhang CZ, Dai CL, Tiwari AK, Ma XX, To KK, Ambudkar SV, Chen ZS, Fu LW. Apatinib (YN968D1) reverses multidrug resistance by inhibiting the efflux function of multiple ATP-binding cassette transporters. Cancer Res. 2010 Oct 15;70(20):7981-91. doi: 10.1158/0008-5472.CAN-10-0111. Epub 2010 Sep 28. PubMed 20876799 ↗
  • Tong XZ, Wang F, Liang S, Zhang X, He JH, Chen XG, Liang YJ, Mi YJ, To KK, Fu LW. Apatinib (YN968D1) enhances the efficacy of conventional chemotherapeutical drugs in side population cells and ABCB1-overexpressing leukemia cells. Biochem Pharmacol. 2012 Mar 1;83(5):586-97. doi: 10.1016/j.bcp.2011.12.007. Epub 2011 Dec 16. PubMed 22212563 ↗
  • Song Z, Yu X, Lou G, Shi X, Zhang Y. Salvage treatment with apatinib for advanced non-small-cell lung cancer. Onco Targets Ther. 2017 Mar 23;10:1821-1825. doi: 10.2147/OTT.S113435. eCollection 2017. PubMed 28367065 ↗

Individual participant data

Plan to share: No — Update after discussion

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03709953
Lead sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Zhou Chengzhi (Director, Head of pneumology department, Principal Investigator, Clinical Professor, Guangzhou Institute of Respiratory Disease) — Principal investigator
First posted
Oct 17, 2018
Start date
Oct 19, 2018
Primary completion
Mar 31, 2021 (estimated)
Completion
Apr 30, 2021 (estimated)
Last update
Oct 24, 2018

Study contacts

Chengzhi Zhou, professor
Contact
doctorzcz@163.com
13560351186

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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