Clinical trial · Interventional
Clinical Study of Chinese Medicine Plus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer
Study of Chinese Medicine Plus Chemotherapy Maintenance Versus Chemotherapy Maintenance in Advanced Non Small Cell Lung Cancer: 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, prospective study method on observation of Traditional Chinese Medicine(TCM) combined with chemotherapy maintenance to prolong the efficacy of long-term survival of advanced non small cell lung cancer(NSCLC) patients.The investigators plan to involve 100 cases for observation in 3 years (50 cases for chemotherapy maintenance, 50 cases for chemotherapy maintenance plus TCM), expecting that integrated TCM combined with chemotherapy maintenance has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of chemotherapy maintenance.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel® | Drug | Docetaxel | ALIAS |
| Gemcitabine® | Drug | Gemcitabine | ALIAS |
| Pemetrexed® | Drug | Pemetrexed | ALIAS |
| placebo granules | Drug | — | UNRESOLVED |
| YangYinFang | Drug | — | UNRESOLVED |
| YiQiFang | Drug | — | UNRESOLVED |
| YiQiYangYinFang | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TCM granules plus Chemotherapy
- description
- TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day until progression or unacceptable toxicity; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
- interventionNames
- Drug: YiQiFang
- Drug: YangYinFang
- Drug: YiQiYangYinFang
- Drug: Gemcitabine®
- Drug: Pemetrexed®
- Drug: Docetaxel®
- type
- PLACEBO_COMPARATOR
- label
- Placebo granules plus Chemotherapy
- description
- Placebo granules: oral granules, oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day; Chemotherapy: Gemcitabine® 1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days or Pemetrexed® 500 mg/㎡, ivgtt 30 min, day 1, every 21 days or Docetaxel® 75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically or cytologically confirmed of stage IIIa-IV NSCLC; 2. The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD); 3. At the age of 18 -75 years old; 4. Physical status score (ECOG PS) ≤ 2 scores; 5. Estimated life expectancy of at least 12 weeks; 6. Participants have no major organ dysfunction: hemoglobin ≥10 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. Planning for chemotherapy maintenance. 8. Informed consent from the patient. Exclusion Criteria: 1. The efficacy evaluation of the first-line therapy is progressive disease; 2. Patient with other malignant tumor except NSCLC 5 years previous to study entry; 3. Patient already receiving targeted therapy or other anticancer treatment; 4. Allergic to chemotherapy drugs; 5. Estimated life expectancy less than 12 weeks; 6. 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; 7. Pregnant or child breast feeding women; 8. Mental or cognitive disorders.
References
Publications (1)
- BACKGROUNDWang Q, Jiao L, Wang S, Chen P, Bi L, Zhou D, Yao J, Li J, Chen Z, Jia Y, Zhang Z, Shen W, Zhu W, Xu J, Gao Y, Gong Y, Xu L. Maintenance Chemotherapy With Chinese Herb Medicine Formulas vs. With Placebo in Patients With Advanced Non-small Cell Lung Cancer After First-Line Chemotherapy: A Multicenter, Randomized, Double-Blind Trial. Front Pharmacol. 2018 Nov 6;9:1233. doi: 10.3389/fphar.2018.01233. eCollection 2018. PMID 30459612