Clinical trial · Interventional
Appatinib Combined With S-1 in the Treatment of Small Cell Lung Cancer
A Single-center, Single-arm Exploratory Clinical Study of Apatinib Mesylate Tablets Combined With S-1 in the Treatment of Second-line or More Advanced Small Cell Lung Cancer
NCT04128800CI-TRIAL-00041161unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib and S-1 group
- interventionNames
- Drug: Apatinib S-1
Primary outcomes (1)
- measure
- Objective Response Rate(ORR)
- timeFrame
- one year
Secondary outcomes (1)
- measure
- Disease Control Rate (DCR)
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The informed consent of the patient must be obtained before any research steps are carried out. 2. Confirmation of SCLC: Histological diagnosis or two imaging diagnoses must be made. 3. Late stage of SCLC, failure of second-line radiotherapy and chemotherapy or dangerous type of patients 4. Male or female subjects \> 18 years old, \< 75 years old 5. There are objective lesions that can be measured by CT. 6. The activity status of KPS was above 80 points. 7. 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. 8. For subjects taking warfarin, the subjects were closely monitored at least once a week until the INR measurement of the subjects was stable at the time of each administration according to the local treatment standards. 9. The upper limit of normal serum creatinine \< 1.5 times is 10. For pregnant women, the results of serum pregnancy test must be negative within 14 days before the start of treatment. 11. All male and female patients participating in this study must adopt reliable contraceptive measures during the trial and within two week. Exclusion Criteria: 1. KPS \< 60 points, or expected survival \< 3 months. 2. Severe cardiovascular diseases . 3. Uncontrollable hypertension . 4. History of human immunodeficiency virus (HIV) infection . 5. Active clinical severe infections (Grade 2, NCI-CTCAE Version 3.0) . 6. Epilepsy patients requiring medication (e.g. steroids or antiepileptic drugs) . 7. History of allogeneic organ transplantation . 8. Patients with signs of hemorrhage or history of disease. 9. Patients undergoing renal dialysis. 10. Chronic obstructive pulmonary emphysema . 11. Gastrointestinal bleeding within 30 days before admission . 12. Patients have a history of esophageal varices bleeding, and subsequently did not receive effective treatment or treatment to prevent recurrence of bleeding.
References
Publications (0)
Data not yet available
No reference posted for this study.