Clinical trial · Interventional
Efficacy and Safety of Apatinib as Third-line Therapy for Primary Pulmonary Lymphoepithelioid Carcinoma
NCT03709953CI-TRIAL-00035424Spark-AL003unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apatinib
- description
- apatinib, 500 mg, po, QD; 28 days every cycle
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 24 months
- description
- Median progression-free survival
Secondary outcomes (3)
- measure
- OS
- timeFrame
- 24 months
- description
- Median overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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: * 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.
References
Publications (14)
- BACKGROUNDBegin 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. PMID 2826922
- BACKGROUNDNgan 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. PMID 15251971
- BACKGROUNDLin 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. PMID 28928848
- BACKGROUNDKim 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. PMID 28149767
- BACKGROUNDKhokhar 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. PMID 28969745
- BACKGROUNDLin 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. PMID 28203414
- BACKGROUNDOoi 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. PMID 12594554