A Phase 2 interventional study of Apatinib S-1 in Small Cell Lung Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-16.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
To evaluate the objective remission rate and disease control rate of apatinib mesylate tablets combined with S-1 in the treatment of advanced small cell lung cancer patients with failed or dangerous radiotherapy or chemotherapy
Lung cancer is one of the malignant tumors with the highest morbidity and mortality in the world. Small cell lung cancer accounts for about 15-20% of all lung cancer. Although the initial treatment is sensitive to radiotherapy and chemotherapy, patients with small cell lung cancer are prone to recurrence and metastasis in the early stage, and ultimately lead to death due to the lack of effective treatment after the disease progresses. Patients with relapsed small cell lung cancer had a poor prognosis; untreated patients had only two to three months of expected survival.Therefore, it is urgent to find a method to treat SCLC.
Two single-arm phase II clinical studies on small cell lung cancer have evaluated the efficacy and safety of bevacizumab combined with first-line chemotherapy for extensive SCLC. Two phase II single arm studies showed good efficacy and safety. Apatinib and bevacizumab are both antiangiogenic agents. S-1 is a new oral fluoropyrimidine anticancer agent, but S-1 has shown a high remission rate for metastatic NSCLC and relapsed NSCLC.
In view of the good efficacy and tolerability of oral chemotherapeutic agent S-1, and the lack of suitable targeted drugs after NGS treatment in relapsed S LCL patients after previous multithreaded treatment, this clinical trial is to study the efficacy and safety of combination of anti-angiogenesis drugs and S-1 in patients with failed or dangerous SCLC after second-line or more radiotherapy and chemotherapy.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.
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Within 14 days before admission, the bone marrow, liver and kidney functions detected by the central laboratory should meet the following laboratory data requirements:
Hemoglobin ≥ 9.0 g/dl; absolute neutrophil count (ANC)1,500 /mm3 ; platelet count ≥ 50,000 /ul; total bilirubin \< 2 mg/dL (3 mg/dL, Child B); ALT and AST \< 5-fold normal value upper limit; alkaline phosphatase \< 4-fold normal value upper limit; PT > 50% or PT-INR \< 2.3, or greater than the control value \< 6 seconds.
Exclusion Criteria:
Drug: Apatinib S-1
apatinib 250 mg PO qd; S-1 40 mg PO in the morning and 60 mg PO in the evening; 14 days in combination, 21 days in a cycle.
Also known as: apatinib mesylate tablets
Objective Response Rate(ORR)
Time frame: one year
Disease Control Rate (DCR)
Time frame: one year
Progression free survival (PFS)
Time frame: one year
Overall survival (OS)
Time frame: one year
Quality of life (QoL)
Time frame: one year
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital