Clinical trial · Observational
Efficacy Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma
Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma: a Randomized Double-blind Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators performed a randomized, double-blind controlled, prospective study method on observation of Traditional Chinese Medicine combined with targeted therapy to prolong the efficacy of long-term survival of advanced pulmonary Adenocarcinoma patients.The investigators plan to involve 404 cases for observation in 3 years (202 cases for each group), expecting that integrated TCM combined with targeted therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving QOL of patients than that of targeted therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGFR-TKI | Drug | — | UNRESOLVED |
| TCM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- TCM plus EGFR-TKIs
- description
- TCM:oral granules,YangYinFang or YiQiFang or YiQiYangYinFang,four packages,twice a day, six months; EGFR-TKIs:oral tablet,Gefitinib 250mg daily or Erlotinib 150mg daily or Icotinib 125 mg three times a day ,until progression or unacceptable toxicity;
- interventionNames
- Drug: TCM
- Drug: EGFR-TKI
- label
- Placebo plus EGFR-TKIs
- description
- TCM Placebo:oral granules,YangYinFang or YiQiFang or YiQiYangYinFang,four packages,twice a day ,six months; EGFR-TKIs:oral tablet,Gefitinib 250mg daily or Erlotinib 150mg daily or Icotinib 125 mg three times a day until progression or unacceptable toxicity;
- interventionNames
- Drug: EGFR-TKI
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically or cytologically confirmed of stage IIIa-IV NSCLC with adenocarcinoma histology; 2. Patient with mutated EGFR will subject to first line target thearapy;patients received at least one cycle platinum-containing chemotherapy regimens with disease progression/recurrence, or intolerant/refuse to proceed with chemotherapy will explore second line target therapy; 3. Physical status score (ECOG PS) ≤ 2 scores; 4. Age ≥18 years old; 5. Estimated life expectancy of at least 12 weeks; 6. Participants have no major organ dysfunction: hemoglobin ≥9 g/dL, absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥100 \*109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN; 7. Informed consent from the patient. Exclusion Criteria: 1. Patient with other malignant tumor except NSCLC 5 years previous to study entry. 2. Wild type EGFR; already receiving targeted treatment or other anticancer treatment such as palliative radiotherapy if it was not finished over 4 weeks or operation was not over 4 weeks before the first drug administration ; 3. Estimated life expectancy less than 12 weeks; 4. Brain metastasis (controlled brain metastasis and steroid free need is excluded). 5. History of cardiovascular disease: Congestive Heart Failure \> grade II in NYHA. Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months; 6. Pregnant or child breast feeding women; 7. Mental or cognitive disorders.
References
Publications (1)
- DERIVEDJiao L, Xu J, Sun J, Chen Z, Gong Y, Bi L, Lu Y, Yao J, Zhu W, Hou A, Feng G, Jia Y, Shen W, Li Y, Zhang Z, Chen P, Xu L. Chinese Herbal Medicine Combined With EGFR-TKI in EGFR Mutation-Positive Advanced Pulmonary Adenocarcinoma (CATLA): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Front Pharmacol. 2019 Jul 2;10:732. doi: 10.3389/fphar.2019.00732. eCollection 2019. PMID 31333456