Efficacy and safety of Yifei Sanjie Recipe combined with anlotinib in the treatment of the second line or above IIIB-IVB non-small cell lung cancer patients: a pilot study

Phase 1

• Conditions: on-small cell lung cancer

• Registration Number: ITMCTR2100004926
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Pathologically and/or cytologically diagnose with IIIB-IVB non-small cell lung cancer;
2. Patients with negative driver genes who have received at least one type of systemic chemotherapy (including combined immune checkpoint inhibitors or anti-vascular drug therapy) have progressed, relapsed, or become intolerable; Patients with positive driver gene (EGFR mutation or ALK fusion positive) who have progressed, relapsed, or become intolerable after receiving corresponding standard targeted drug therapy;
3. Aged from 18 to 75 years, male or female;
4. Eastern Cooperative Oncology Group (ECOG) performance scale (PS) score of 0-2;
5. The expected survival time>=24 weeks;
6. A measurable lesion based on the RECIST criteria;
7. Adequate liver and kidney function (creatinine clearance rate>=60ml/min; total bilirubin<=1.5xULN; alanine aminotransferase, aspartate aminotransferase<=2.5xULN));
8. Hemoglobin>100g/L, platelet count>100x10^9/L, neutrophils>1.5x10^9/L;
9. Agree to contraception during the trial and within six months after the trial ends;
10. Patients or their family members signed the informed consent.

Exclusion Criteria

1. With unstable brain metastases or at risk of bleeding after being evaluated by researchers;
2. Previously used anlotinib or apatinib;
3. Concomitant with other types of malignant tumors;
4. Difficulties with oral medications (such as dysphagia, chronic diarrhea, and intestinal obstruction);
5. Female patients with positive pregnancy test results 7 days before enrollment;
6. Women who are pregnant or breastfeeding;
7. Patients with mental illness or mental retardation;
8. Allergy or intolerance to the study drug.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival;

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate;Overall survival;Patient-reported Outcome;Disease Control Rate;