Status:
UNKNOWN
Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
Lead Sponsor:
Third Military Medical University
Conditions:
Extensive-stage Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that, compared with placeb...
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis of small cell lung caner
- Advanced small cell lung cancer who had no prior cisplatin-based chemotherapy or radiotherapy,at least one measurable lesion (by RECIST1.1)
- Males or females between 18 Years to 75 Years.
- Performance status of 0～2 on the ECOG criteria.
- Main organs function is normal
- Expected survival is above three months.
- with asymptomatic brain metastases.
- At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion \>= 20mm or spiral CT \>=10mm).
- Adequate hematologic (Leukocyte count \>= 4.0×109/L, neutrophil count\>=2.0×109/L, hemoglobin\>=95g/L, platelets\>=100×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT)
- =\<upper normal limit(UNL) x1.5, bilirubin level =\< UNL x 1.5).
- Patient can take oral medicine.
- Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
Exclusion
- History of cardiovascular disease: congestive heart failure (CHF) \> New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).
- Serious clinical infection (\> NCI-CTCAE version 4.0 ,infection standard II).
- Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- The patients had accepted allogeneic organ transplantation.
- Bleeding tendency or coagulation disorders.
- patients who need renal dialysis.
- suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
- uncontrolled hypertension (systolic pressure\>150 mmHg , or diastolic pressure\> 90 mmHg).
- thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months).
- pulmonary hemorrhage \>CTCAE grade 2 within 4 weeks before first use of drugs.
- Other organ hemorrhage \>CTCAE grade 3 within 4 weeks before first use of drugs.
- severe uncured wounds, ulcers or fracture.
- uncured dehydration.
- Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect.
- Patients are allergic to drugs used in research.
- Factors influencing the safety and compliance of patients.
- Inability to comply with protocol or study procedures.
- Pregnant or breast-feeding.
- The researcher believe that the Patient is not suitable to participate in the study.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03781869
Start Date
December 1 2018
End Date
December 1 2021
Last Update
December 20 2018
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