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A clinical study of combining etoposide and apatinib to cure recurrence and transfer of small cell lung

A clinical study of combining etoposide and apatinib to cure recurrence and transfer of small cell lung

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011013
Enrollment
Unknown
Registered
2017-03-29
Start date
2018-01-15
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrence and transfer of small cell lung

Interventions

Case series:etoposide plus apatinib

Sponsors

The Affiliated Tumor Hospital Of General Hospital Of Ningxia Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Pathological or cytological diagnosed small cell lung cancer; 2. Aged 18-75, man or women; 3. According to standard RESCIST1.1, evaluation target lesion, conventional CT= 2cm , the spiral CT= 1cm. Random two weeks lesions measurement; 4. Had a systemic treatment of recurrence or metastasis in patients with small cell lung cancer (patients had palindromia and metastasis during 6 month with systemic chemotherapy;patients had palindromia and metastasis during 6 month with systemic chemotherapy, appear again after treatment with the original plan, palindromia and metastasis); 5. Expected survival time =3 month; 6. ECOG 0-2; 7. Baseline laboratory tests meet the following criteria: Bone marrow function ANC =2.0×10^9/L; PLT =100×10^9/L; HB=95g/L; Liver function: STB, CB= ULN×1.5; ALT and AST= ULN×2.5 (In the absence of liver metastasis) or = ULN×5(had a liver metastasis); Renal function: Cr=ULN; Ccr = 60 ml/min; Blood coagulation function: (PT INR)= ULN×1.5; 8. Women of childbearing age are willing to using appropriate methods of contraception during the test and 8 weeks after having the last experimental drug, and should have a pregnancy check before test if necessary, the result should be negative; For men, must be agree to use appropriate methods of contraception or have sterilization surgery during the experiments or at the end of the experiments after 8 weeks; 9. The patients were willing to join in this study, and sign the informed consent, good adherence, cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Need cure brain active metastasis (defined as New York heart association (NYHA) level 3 and severe arrhythmia; 4. Occurred =CTCAE ( annex 6) level 3 bleeding within 4 weeks before the group; 5. Need long-term daily use of anticoagulants or vitamin K antagonists, such as warfarin and heparin or its analogues, but not for the purpose of prevention using small dose of warfarin (=1 mg/d ) or aspirin (=100 mg/d) except; 6. Severe infection, need intravenous antibiotics, antifungal and antiviral treatment; 7. pregnancy, possible pregnancy patients, had not effective birth control and the will of the patients with pregnancy and lactation patients; 8. Known inherited or acquired bleeding and thrombosis tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, hypersplenism, etc.); 9. Long-term did not cure wound or fracture; 10. Acceptd major surgery or severe traumatic injury, fractures, or ulcer before into the group received within 4 weeks; 11. Have a significant factors that affect oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc; 12. Urine routine prompt urine protein =+ +; or confirm 24 hours urinary protein quantity= 1.0 g; 13. Has a history of psychiatric drugs abuse and can't quit or have a mental disorder; 14. Researchers determine other possibility that affect the clinical research and research results.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;DOR;DCR;ORR;

Countries

China

Contacts

Public ContactRen Zhao

The Affiliated Tumor Hospital Of General Hospital Of Ningxia Medical University

zhaorendocter@126.com13995218598

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026