Status:
COMPLETED
S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
Lead Sponsor:
Taizhou Hospital
Conditions:
Small Cell Lung Cancer Recurrent
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence after at least one st...
Detailed Description
Although SCLC is very responsive to initial treatment, most patients relapse with relatively resistant disease.These patients have a median survival of only 4 to 5 months when treated with further sys...
Eligibility Criteria
Inclusion
- Histological or cytologically confirmed small cell lung cancer;
- Systemic chemotherapy that has previously received at least one or more lines regimen, followed by disease progression or recurrence;
- Age 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
- participants had at least one measurable target lesion by RECIST1.1
- The main organ function meets the following criteria:absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥80 × 109 / L, hemoglobin ≥ 80 g / L;total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
- Patients should participate in the study voluntarily and sign informed consent
Exclusion
- Patients who have been used anti-angiogenesis inhibitors,such as (such as sunitinib,bevacizumab,endostar et al.
- Subjects with symptomatic brain metastases;
- Patients whose primary lesion with active bleeding within 4 months
- Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg
- Patients with active or unable to control serious infections
- Patients who are pregnant or breastfeeding.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03823118
Start Date
March 1 2019
End Date
April 17 2021
Last Update
February 23 2023
Active Locations (3)
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1
Taizhou Hospital, Wenzhou Medical University
Taizhou, Zhejiang, China, 317000
2
Enze Hospital
Taizhou, Zhejiang, China
3
Sanmen People's Hospital
Taizhou, Zhejiang, China