Clinical trial · Observational
Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical Surgery
Observational Study on the Efficacy and Safety of Huaier Granules Compared With Platinum Containing Dual Drug Combination Chemotherapy in Adjuvant Therapy for Resectable Stage II-IIIA Non-small Cell Lung Cancer After Radical Surgery
NCT06109454CI-TRIAL-00077014recruitingClinicalTrials.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)
This study is a multicenter, prospective, and observational clinical study aimed at exploring whether the 3-year DFS in the Huaier group is not inferior to the control group receiving standard platinum dual-drug chemotherapy.
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 |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| Huaier granule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Huaier Granule
- description
- The subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules.
- interventionNames
- Drug: Huaier granule
- label
- Control
- description
- The subjects received standard platinum dual-drug chemotherapy.
- interventionNames
- Other: Control
Primary outcomes (1)
- measure
- 3-year disease-free survival (DFS) rate
- timeFrame
- start of treatment until 3-year follow-up
- description
- The proportion of participants who did not experience disease recurrence or death within 3 years after undergoing lung cancer radical surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years old ≤ age ≤ 75, regardless of gender. * Confirmed as non-small cell lung cancer by histopathology, with pathological staging of stage Ⅱ-ⅢA. * Received radical R0 resection of lung cancer within 2 months before enrollment, and did not receive any postoperative adjuvant therapy or preoperative neoadjuvant therapy. * ECOG(Eastern Cooperative Oncology Group)score:0-2. * The patient voluntarily participated in the study, agreed to cooperate with the researcher for data collection, and signed an informed consent form. Exclusion Criteria: * Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (Huaier group). * Those who have difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation, and other causes of difficulty in taking oral medication. * Non-small cell lung cancer patients who plan to receive targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, radiotherapy, synchronous radiotherapy and chemotherapy during the study period. * The patient has a history of other new malignant tumors within 5 years. * The expected survival time of the patient is less than half a year. * Surgical complications that have not recovered or are accompanied by severe infections after radical resection of lung cancer. * Pregnant or lactating women or planned pregnancy preparation. * The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect in the past one month (including but not limited to compound cantharidin capsule, cinobufagin capsule, Kangai injection, Brucea javanica injection, etc., the specific instructions shall prevail). * The patient suffers from severe mental illness or other reasons that the researcher deems unsuitable to participate in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.