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Phase II clinical study for anlotinib combined with radiotherapy for second-line and above chemotherapy failed extensive stage small cell lung cancer

Phase II clinical study for anlotinib combined with radiotherapy for second-line and above chemotherapy failed extensive stage small cell lung cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021820
Enrollment
Unknown
Registered
2019-03-11
Start date
2019-07-01
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

small cell lung cancer

Interventions

Case series:anlotinib combined with radiotherapy

Sponsors

Third Clinical School of Xinjiang Medical University (Affiliated Tumor Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Diagnosed with extensive stage SCLC through pathology, with measurable nidus; 3. Disease progression after second-line and above chemotherapy; 4. ECOG PS 0-2; 5. The subject has recovered from the damage caused by other treatments. For example, interval=6 weeks after nitroso or mitomycin; =4 weeks after other cytotoxic drugs or bevacizumab; =2 weeks after target EGFR TKI medicines; 6. Adequate organ function, defined as: Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^3/microliters (µL), hemoglobin greater than or equal to 9.0 grams/deciliter (g/dL), and platelets greater than or equal to 800 x 10^3/µL; Total bilirubin less than or equal to 1.5 xUpper Limit of Normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than or equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase elevation is due to liver metastases,Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 60 milliliters per minute (ml/min) (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection), LVEF=50%; 7. No contraindications of radiotherapy or amlotinib; 8. Signed and dated informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with NSCLC through pathology; 2. Small cell lung cancer along with hemoptysis (>20ml/day); 3. Patients with significant bleeding risk; 4. Uncontrolled arterial hypertension greater than or equal to 150/90mmHg despite standard medical management; Having a history of unstable angina pectoris; Clinically relevant congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia (including QTC=480ms) myocardial ischemia or myocardial infarct; 5. Patients with abnormal coagulation function (INR>1.5 or PT>ULN+4 sec or APTT >1.5 ULN), or bleeding tendency, or being take anticoagulants such as warfarin and heparin; 6. Get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents, deevenous thrombosis, and pulmonary embolism; 7. Urinary protein quantitative value=2+and quantitative protein is >1.0g in a 24 hour urine sample 8. With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus); 9. Have participated in other clinical trials of anti-tumor medicine within 4 weeks; 10. The investigator determines other conditions that may affect the conduct of the clinical study and the outcome of the study.

Design outcomes

Primary

MeasureTime frame
OS;

Countries

China

Contacts

Public ContactHaifeng Wang

Third Clinical School of Xinjiang Medical University (Affiliated Tumor Hospital)

gadfly7200@163.com+86 13639921852

Outcome results

None listed

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