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This study is a single arm, multi-center, prospective clinical trial. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan combined with anlotinib hydrochloride for relapsed small-cell lung cancer, who have progressed on or less than 6 month after platinum-based first-line therapy.
Patients will receive irinotecan liposome injection at 70 mg/m^2 intravenously, on Days 1 of every 14-day cycle and anlotinib (12 mg/day) for 2 consecutive weeks and then discontinued for 1 week. The treatment is continued until disease progression or intolerable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan Liposome and anlotinib | Experimental | The treatment is continued until disease progression or intolerable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan Liposome | Drug | 70 mg/m^2 , d1, Q2W, iv |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | To evaluate anti-tumor efficacy | From date of first dose until the date of first documented progression, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | To evaluate anti-tumor efficacy | From date of first dose until the date of first documented progression, assessed up to 24 months |
| Duration of Response(DoR) | To evaluate anti-tumor efficacy |
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Inclusion Criteria:
1) Aged ≥18 and ≤75 years old;
2) Histologically or cytologically confirmed small cell lung cancer;
3) At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;
4) Radiologically confirmed recurrence or progression within 6months after platinum-based, first-line chemotherapy or chemoradiation therapy;
5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
6) Expected survival of more than 3 months;
7) Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to no more than Grade 1 of CTCAE 5.0 criteria or baseline, with the exception of alopecia or other toxicity without safety concerns by the investigators' judgment);
8) Adequate major organ function, patients should meet the following criteria:
① Bone marrow function: absolute neutrophile count (ANC)≥1.5×109/L,platelet (PLT)≥100×109/L, hemoglobin (Hb)≥90g/L, white blood cell (WBC)≥3.0×109/L;
② Hepatic function: total bilirubin≤1.5×upper limit of normal value(ULN);ALT and AST≤2.5×ULN,liver metastasis:≤5×ULN;
③ Renal function: serum creatinine ≤1.5×ULN and creatinine clearance rate ≥60 mL/min;
④ Coagulation function:Activated partial thromboplastin time(APTT)、International normalized ratio(INR)、prothrombin time (PT)≤1.5×ULN;
⑤ urine routines show urine protein < 2+(when urine protein >2+, urine protein quantity< 1.0 g during 24 hours before 7 days);
9) Patients fully understood and volunteered to participate in the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jialei Wang, Doctor | Contact | 021-64175590 | 88900 | luwangjialei@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jialei Wang, Doctor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
| C000625192 | anlotinib |
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| Anlotinib | Drug | 12 mg, qd, po for 2 consecutive weeks and then discontinued for 1 week. |
|
|
| From date of first dose until the date of first documented progression, assessed up to 24 months |
| Progression-Free Survival (PFS) | To evaluate anti-tumor efficacy | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Overall Survival (OS) | To evaluate anti-tumor efficacy | From date of first dose until the date of death from any cause , assessed up to 24 months |
| Incidence and severity of adverse events | To evaluate the safety | date of the first dose to 28 days after permanent treatment termination |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |