A single-center, one-arm exploratory clinical study for Apatinib mesylate combined with S-1 in the treatment of second-line or higher radiochemotherapy failure or sinister advanced small cell lung cancer

A single-center, one-arm exploratory clinical study for lapatinib mesylate combined with S-1 in the treatment of second-line or higher radiochemotherapy failure or sinister advanced small cell lung cancer

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900024127

Enrollment

Unknown

Registered

2019-06-26

Start date

2019-07-01

Completion date

Unknown

Last updated

2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SCLC

Interventions

1:Apatinib Mesylate combined with Tegafur

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient's informed consent must be obtained prior to any research steps; 2. Confirmation of SCLC: must be confirmed by histology or two imaging studies; 3. SCLC late, second-line and above radiotherapy, chemotherapy failure or sinister patients; 4. Male or female subjects > 18 years old, =80 points; 7. The bone marrow, liver and kidney function detected by the central laboratory must meet the following laboratory data requirements within 14 days prior to enrollment: Hemoglobin >= 9.0 g/dl, Absolute neutrophil count (ANC)>=1,500/mm^3, Platelet count>= 50,000/ul, Total bilirubin 50% or PT-INR<2.3, or greater than the control value <6 seconds. 8. For subjects taking warfarin, subjects should be closely monitored at least once a week until each dose is taken according to local treatment criteria. The subject's INR measurement has stabilized; 9. Upper limit of normal value of serum creatinine <1.5 times; 10. For women with pregnancy ability, the serum pregnancy test result must be negative within 14 days before starting treatment; 11. All male and female patients enrolled in this study must take reliable contraceptive measures during the trial and within two weeks of completing the trial.

Exclusion criteria

Exclusion criteria: 1. KPS grade 2, NCI-CTCAE version 3.0); 6. Requires medical treatment Patients with seizures (such as sputum or anti-epileptic drugs); 7. History of allogeneic organ transplantation; 8. Patients with signs or history of bleeding physiology; 9. Patients undergoing renal dialysis; 10. Chronic obstructive emphysema episodes; 11. History of gastrointestinal bleeding within 30 days prior to enrollment; 12. The patient had a history of esophageal varices bleeding and subsequently did not receive effective therapy or treatment to prevent recurrence of bleeding.

Design outcomes

Primary

Measure	Time frame
ORR;DCR;	—

Secondary

Measure	Time frame
PFS;OS;Qol;	—

Countries

China

Contacts

Public ContactNingbo Liu

Tianjin Medical University Cancer Institute & Hospital

979566110@qq.com+86 15822117210

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026