Clinical trial · Interventional
Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)
Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III NSCLC After Postoperative Adjuvant Chemotherapy: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial, Along With a Registration Study
NCT03198117CI-TRIAL-00043880terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in patient recruitment
Summary
Brief summary (as posted)
This study including two parts，one part is a randomized clinical trial design，another part is a registration study.
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 |
|---|---|---|---|
| Huaier Granule | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Huaier Granule
- description
- Huaier Granule
- interventionNames
- Drug: Huaier Granule
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- placebo
- interventionNames
- Other: placebo
- type
- NO_INTERVENTION
- label
- No-treatment Control
- description
- patients refused any treatment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with complete resection who are at TNM (primary tumor, regional nodes, metastasis) stage II-Ⅲa, postoperative pathology confirmed for non-small cell lung cancer; * Has completed four cycle standard solution of adjuvant chemotherapy, or refused to accept the postoperative adjuvant chemotherapy; * Patients between 18 and 70 years old, no gender restriction; * Eastern Cooperative Oncology Group (ECOG) PS of two or less; * Before the start of the study, patient fully understands the study and is willing to sign the informed consent form; Exclusion Criteria: * Receiving adjuvant chemotherapy patients started greater than 24 weeks from surgical resection; * Refused adjuvant chemotherapy patients started greater than 8 weeks from surgical resection; * Suspected malignant pleural effusion; * There is no clear pathological diagnosis; * Combined with other cancer; * Patient have a positive surgical margin; * Accept other treatment for lung cancer of postoperative； * Combined with severe idiopathic disease of liver, kidney and hematopoietic system; * Combined psychosis or AIDS; * Allergy to the test drug; * Pregnant or lactating women; * Participation in any other clinical trial within three months; * Conditions that are considered not suitable for this study investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.