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Study for apatinib plus EP in the first line treatment of patients with extensive-stage small-cell lung cancer

Study for apatinib plus EP in the first line treatment of patients with extensive-stage small-cell lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023771
Enrollment
Unknown
Registered
2019-06-11
Start date
2019-06-11
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

small-cell lung cancer

Interventions

Case series:Apatinib 250mg po, qd, q3w, continuous taken
EP: Etoposide: 100mg/ m2, d1-3, q3w, 4-6 cycles
Cisplatin: 75 mg/ m2, d1, q3w, 4-6 cycles

Sponsors

Tangshan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old man and female; 2. Pathologically diagnosed with small cell lung cancer; 3. Imageology diagnosed with extensive-stage; 4. At least one measurable lesion (measuring=10mm on spiral CT scan, satisfying the criteria in RECIST1.1) 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Life expectancy greater than or equal to 3 months; 7. Major organ function has to meet the following certeria: 1) For results of blood routine test (without blood transfusions and blood products within 14 days, without G-CSF and other hematopoietic stimulating factors): HB=90g/L; ANC=1.5×10^9/L; PLT=80×10^9/L; 2) For results of blood biochemical test: TBIL<1.5×ULN; ALT and AST=2.5×ULN, but =5×ULN if the transferanse elevation is due to liver metastase; BUN and Cr=1×ULN or Endogenous creatinine clearance rate =50ml/min; 9. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks; 10. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. History of serious allergy or patients with allergic constitution; 2. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 3. Patients who 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) 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency; 6. Patients with pregnant or planning a pregnancy; 7. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 8. Less than 4 weeks from the last clinical trial; 9. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 10. Receipted previous therapy for extensive-stage; 11. The researchers think inappropriate.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;DCR;ORR;Safety;

Countries

China

Contacts

Public ContactGuogui Sun

Tangshan People's Hospital

guogui_sun2013@163.com+86 13315532983

Outcome results

None listed

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