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Androtinib Combined with S - 1 in the Treatment of Advanced Non - small Cell Lung Cancer: A Phase II Clinical Study

Androtinib Combined with S - 1 in the Treatment of Advanced Non - small Cell Lung Cancer: A Phase II Clinical Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020948
Enrollment
Unknown
Registered
2019-01-22
Start date
2019-01-25
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Non - small Cell Lung Cancer

Interventions

Case series:Anlotinib combined with oral S-1

Sponsors

Mianyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18-75 years male and female; 2) Pathologically confirmed stage IV NSCLC; 3) ECOG PS score: 0-2; 4) Patients with negative driving genes were evaluated for progression or intolerance after at least two different regimens of chemotherapy, or patients with positive driving genes (EGFR mutation or ALK rearrangement) were evaluated for progression or intolerancetreated after the treatment of TKI and at least one regimen of chemotherapy; 5) According to RECIST, patients have measurable lesions; 6) The estimated survival time is more than 12 weeks; 7) With well main organs function; 8) Hemoglobin (>100 g/L); Platelet count > 100 *10^9/L; The number of neutrophils more than 1.5 x 10^9/L; 9) serum creatinine =1.25×ULN, or creatinine clearance rate > 60 mL/min; 10) TBIL =1.5× ULN; AST (SGOT) and ALT(SGPT)=2.5×(ULN), Alkaline phosphatase = 5×ULN; 11) No interstitial pneumonia or previous history of interstitial pneumonia; 12) Patients or family members signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. There are other malignant tumors within 1, 5 years or now; 2. Pregnant or Lactating Women; 3. Small cell lung cancer (including small cell carcinoma and other types of cancer mixed with non-small cell carcinoma); 4. Various factors affecting oral medication (inability to swallow, chronic diarrhea, esophageal fistula and intestinal obstruction, significantly affecting drug use and absorption); 5. A medical history or habit of bleeding,regardless of its severity;?Patients with unhealed wounds, abnormal coagulation, ulcers, or fractures after bleeding or bleeding events Patients who participated in clinical trials of other drugs within 6 and 4 weeks; 6. Arterial / venous thrombosis, such as cerebrovascular accident (including transient ischemic stroke), deep venous thrombosis and pulmonary embolism, occurred within 6 months; 7. Other patients considered unsuitable for inclusion by physicians; 8. Central lung squamous cell carcinoma or non-small cell lung cancer with hemoptysis; 9. Those who abuse psychotropic drugs or are diagnosed with mental disorders; 10. Patients who have been treated with Anlotinib or S - 1 in the past; 11. Patients who had received extended field radiotherapy (EF-RT) within the first 4 weeks of grouping or limited field radiotherapy within the first 2 weeks of grouping and were recommended for evaluation of the lesion; Or the lesion to be evaluated is prepared for local treatment (radiotherapy or radiofrequency ablation); 12. EGFR and ALK mutations were positive and did not receive TKIs treatment; 13. Any serious or uncontrollable disease; 14. Participate in other clinical trials of antitumor drugs within 4 weeks; 15. Patients were diagnosed as diseases that seriously endangered their safety or affected the completion of this study.

Design outcomes

Primary

MeasureTime frame
Complete response rate;partial response rate;

Secondary

MeasureTime frame
progression-free survival;Disease control rate;effective time;safety;

Countries

China

Contacts

Public ContactXiaobo Du

Mianyang Central Hospital

duxiaobo2005@126.com+86 13550822229

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026