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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004926
Enrollment
Unknown
Registered
2021-06-08
Start date
2021-06-06
Completion date
Unknown
Last updated
2023-02-20

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

Sponsors

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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 bilirubin100g/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

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.

Design outcomes

Primary

MeasureTime frame
Progression-free Survival;

Secondary

MeasureTime frame
Objective Response Rate;Overall survival;Patient-reported Outcome;Disease Control Rate;

Countries

China

Contacts

Public ContactLin Lizhu

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

lizhulin26@yahoo.com+86 13501505588

Outcome results

None listed

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