Efficacy and safety of irinotecan after chemotherapy in combination with immunotherapy in patients with extensive stage small cell lung cancer: a phase II trial
Phase 2
Recruiting
- Conditions
- Extensive stage small cell lung cancer
- Registration Number
- JPRN-UMIN000042892
- Lead Sponsor
- Third department of internal medicine, Universtiy of Fukui
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who previously treated with irinotecan 2) Patients with homozygous polymorphisms for UGT1A1*28 and *6 (*28/*28, *6/*6, and *6/*28) 3) Diarrhea (grade 1 or more) before the treatment. 4) Uncontrolable pleural or pericardial effusion. 5) Within 2 weeks after radiotherapy. 6) Operation within 4 weeks. 7) Active double cancer. 8) Active infectious disease. 9) Severe complications including heart failure, hepatic failure, renal failure, paresis of intestine, and ileus. 10) Pregnant woman. 11) HBs antigen positive. 12) Patients who received systemic corticosteroid (10mg or more prednisolone conversion). 13) The subjects whom the doctor excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival, disease control rate, overall survival, and safety. Subset analysis of efficacy stratified by smoking history and objective response of previous treatment.