Clinical trial · Interventional
Efficacy Study of Integrated TCM Combined With Chemotherapy in Postoperative NSCLC Patients
State Administration of Traditional Chinese Medicine of Shanghai
NCT01441752CI-TRIAL-00022734completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 multi-center, randomized, controlled, double-blind, prospective study on evaluating effect of chemotherapy combined with or without integrated TCM on quality of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. The investigators plan to involve 600 cases for observation in 3 years (300 cases for each group), expecting that QOL of postoperative NSCLC patients can be improved by integrated TCM combined with chemotherapy compared to that by chemotherapy alone.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| TCM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy + TCM group
- description
- The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles. Prescriptions formulated into granules origin from Professor Liu Jiaxiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe . Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.
- interventionNames
- Drug: TCM
- type
- PLACEBO_COMPARATOR
- label
- Chemotherapy + placebo group
- description
- The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles.we compromise the raw materials for the placebo including 10% of Chinese medicine, food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Meet the diagnostic criteria of primary bronchial lung cancer, and pathologically or cytologically confirmed of NSCLC (squamouscarcinoma, adenocarcinoma, adenosquamous carcinoma and large cell carcinoma) patients; 2. Age \> 18 years old; 3. TCM syndromes are Yin deficiency, Qi deficiency, deficiency of both Qi and Yin, deficiency of both Spleen and Kidney; 4. Physical status score (ECOG PS) ≤ 2 scores; 5. Stage Ib \~ Ⅲb with complete resection, chemotherapy is performed in 6 weeks after resection, including tumor size \> 2cm of stage Ia; 6. Blood routine: N \> 1.5×109/L、PLT \> 100×109/L, normal liver function and kidney function; 7. Voluntarily involved to clinical study and sign informed consent. Exclusion Criteria: 1. Suffering from other primary malignant tumor in 5 years; 2. Incomplete resection or uncertain to take resection; 3. Serious disease of heart, liver, kidney with severe dysfunction; 4. Pregnancy or breast-feeding women; 5. Mental or cognitive disorders which would influence judgment of QOL in this study; 6. During or had adjuvant chemotherapy; 7. Being participating other drug trials; 8. Allergy to the drug in our study.
References
Publications (3)
- DERIVEDWang Y, Jiao L, Chen Z, Xu J, Che J, Huang H, Zhang L, Shen X, Yang Y, Zhao T, Zhang J, Zhou D, Wang Q, Yao J, Yang W, Sun C, Li J, Bi L, Ding R, Goodfellow I, Gong Y, Xu L. Adjuvant Chemotherapy with Traditional Chinese Herbal Granules Versus Placebo in Resected Non-Small Cell Lung Cancer: Updated Survival Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251409081. doi: 10.1177/15347354251409081. Epub 2026 Jan 27. PMID 41589575
- DERIVEDWang Q, Jiao L, Wang S, Chen P, Bi L, Zhou D, Yao J, Li J, Wang L, Chen Z, Jia Y, Zhang Z, Shen W, Zhu W, Xu J, Gao Y, Xu L, Gong Y. Adjuvant Chemotherapy with Chinese Herbal Medicine Formulas Versus Placebo in Patients with Lung Adenocarcinoma after Radical Surgery: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Biol Proced Online. 2020 Mar 1;22:5. doi: 10.1186/s12575-020-00117-5. eCollection 2020. PMID 32140080
- DERIVEDXu L, Li H, Xu Z, Wang Z, Liu L, Tian J, Sun J, Zhou L, Yao Y, Jiao L, Su W, Guo H, Chen P, Liu J. Multi-center randomized double-blind controlled clinical study of chemotherapy combined with or without traditional Chinese medicine on quality of life of postoperative non-small cell lung cancer patients. BMC Complement Altern Med. 2012 Aug 1;12:112. doi: 10.1186/1472-6882-12-112. PMID 22853619