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Status unknownNCT02995187Updated Sep 7, 2017

Study of Apatinib as Third-line and Later Therapy in Patients With Small Cell Lung Cancer (SCLC)

A Phase 2 interventional study of Apatinib Mesylate tablet in Small Cell Lung Cancer, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-07.

Sponsored by Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

This is a Single-center, Open-label, Single-arm,Non-randomized exploratory clinical trial evaluating the efficacy and safety of Apatinib for third-line and later treatment of patients with small cell lung cancer.

Read the detailed description

Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)and second-line therapy with topotecan has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and 2-year survival is less than 10%. There is no standard treatment recommendation for this group of patients who failed to second-line therapy and had good performance status. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine. And this clinical trial is designed to prospectively investigate the efficacy and safety of apatinib in recurrent SCLC patients in our center.

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Conditions studied

  • Small Cell Lung Cancer

Keywords

  • Apatinib
  • Third-line and Later Therapy
  • Small Cell Lung Cancer
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 25 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

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

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Who can participate

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

Inclusion criteria

  1. 18 years to 75 years;
  2. Had a histologically or cytologically confirmed diagnosis of SCLC;
  3. Had received at least 2 lines chemotherapy regimen and must include basis of the platinum regimen after which disease diagnosed;
  4. Have not received VEGFR-TKI;
  5. Had a life expectancy of at least 3 months;
  6. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2;
  7. Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1), larger than 10 mm in diameter by spiral CT scan;
  8. Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.5×the upper limit of normal(ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.25 x ULN, creatinine clearance rate > 45ml/min;
  9. For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug;
  10. Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion criteria

Exclusion Criteria:

  1. Patients with non-small cell lung cancer;
  2. Imaging (CT or MRI) results indicate that the existence of central tumors locally invading the large vessel could be detected, or apparent pulmonary cavity or necrotizing tumors;
  3. Patients with clinical symptoms of brain metastases or meningeal metastasis;
  4. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
  5. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\<50%;
  6. Coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation;
  7. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g;
  8. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening;
  9. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; Patients who experienced bleeding symptoms of clinical significance , or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc;
  10. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening;
  11. Allergic to any ingredients of Apatinib;
  12. Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
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Study design

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

Study arms

  • Experimental
    Apatinib Mesylate tablet

    Patients received oral apatinib 500 mg in tablet once daily, a treatment cycle was defined as 28 days (4 weeks).

    Drug: Apatinib Mesylate tablet

Interventions

  • DrugApatinib Mesylate tablet

    Apatinib 500 mg in tablet once daily

    Also known as: Apatinib

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What researchers measure

Primary outcomes

  1. Progression-free survival

    Time frame: up to 3 years

Secondary outcomes

  1. Overall survival

    Time frame: up to 3 years

  2. Disease Control Rate

    Time frame: up to 3 years

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: up to 3 years

Other outcomes

  1. tumor phosphorylated VEGFR2 (p-VEGFR2) expressions

    Time frame: baseline

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Study locations

1 of 1 sites recruiting
  • Chinese Academy of Medical Sciences
    Beijing, China
    Recruiting
08

References and documents

Publications

  • Liu Y, Hu X, Jiang J, Yang L, Zhou S, Liu P, Li J, Wang Y, Hao X, Shi Y. A Prospective Study of Apatinib in Patients with Extensive-Stage Small Cell Lung Cancer After Failure of Two or More Lines of Chemotherapy. Oncologist. 2020 May;25(5):e833-e842. doi: 10.1634/theoncologist.2019-0391. Epub 2020 Apr 6. PubMed 32250517 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02995187
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Yutao Liu (Associate Chief Physician, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Dec 16, 2016
Start date
Dec 2016
Primary completion
May 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Sep 7, 2017

Study contacts

Yutao Liu, M.D.
Contact
13911901165@139.com
+8613911901165
Yutao Liu, M.D.
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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