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A pilot study for Apatinib Mesylate combined with Gifitinib in First-line treatment of Lung Adenocarcinoma with malignant pleural effusion or pericardial effusion

A pilot study of Apatinib Mesylate combined with Gifitinib in First-line treatment of Lung Adenocarcinoma with malignant pleural effusion or pericardial effusion

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017332
Enrollment
Unknown
Registered
2018-07-25
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

Carcinoma of the lungs

Interventions

Case series:Apatinib mesylate tablets combined with gefitinib

Sponsors

Jiangsu Subei People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years male and female; 2. Lung adenocarcinoma diagnosed by pathology or cytology was evaluated by imaging with malignant pleural effusion or pericardial effusion with at least one measurable lesion (according to RESIST1.1 criteria). 3. The gene was tested and the results were EGFR positive. 4. No systematic standard chemotherapy or targeted therapy has been received in the past. 5. ECOG score: 0-2; 6. The estimated survival time was more than 12 weeks. 7. The damage caused by other treatment was recovered, in which the interval of nitrite or mitomycin was more than 6 weeks, other cytotoxic drugs, radiotherapy or operation = 4 weeks, and the wound healed completely. 8. If the main organs function properly, the following criteria are met: (1) the standard of blood routine examination should be met (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factor correction): HB=100g/L; ANC=1.5×10^9/L; PLT=90×10^9/L; (2) biochemical tests are subject to the following criteria: TBIL 45 ml/min) (Cockcroft-Gault formula); 9. Women of childbearing age must have taken reliable contraception or performed pregnancy tests (serum or urine) within 7 days of admission, with negative results, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last trial. In the case of men, consent must be given to the use of appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the drug; 10. The subjects volunteered to join the study and signed an informed consent form, which showed good compliance and was accompanied by follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with hypertension who could not be reduced to normal range by antihypertensive drugs (systolic blood pressure > 140mm Hg, diastolic blood pressure > 90 mmHg) had myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QT interval = 440ms) and cardiac insufficiency of grade II; 3. Has the obvious influence oral medicine absorption factor, such as cannot swallow, the chronic diarrhea and the intestinal obstruction and so on; 4. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN 4 seconds or APTT > 1.5 ULN),) had a tendency to bleed or were undergoing thrombolytic or anticoagulant therapy. 5. Pulmonary hemorrhage = CTCAE grade 2 was found within 4 weeks before the first medication, and other parts of = CTCAE grade 3 were bleeding in 4 weeks before the first medication; 6. Arteriovenous thrombotic events such as cerebrovascular accident (including transient ischemic attack) deep venous thrombosis and pulmonary embolism occurred within 6 months before the first medication; 7. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; low doses of warfarin (1mg) were allowed for preventive purposes, provided that the international standardized ratio of prothrombin time (INR) was less than 1.5. Once a day or a small dose of aspirin (between 80mg and 100mg daily); 8. The researchers judged other situations that might affect the conduct of clinical research and the results of the study; 9. Patients with active brain metastasis.

Design outcomes

Primary

MeasureTime frame
Biomarker;

Countries

China

Contacts

Public ContactXu Xingxiang

Jiangsu Subei People's Hospital

xuxx63@sina.com+86 18051062315

Outcome results

None listed

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