Non-small Cell Lung Cancer
Conditions
Brief summary
This study including two parts，one part is a randomized clinical trial design，another part is a registration study.
Detailed description
This study include a multicenter, randomized, controlled, double-blind, placebo-controlled post-market clinical trial and a registration study. The randomized clinical trial included subjects (n =798) will be randomly divided into experimental (n = 532) and control groups (n =266) according to a random number table. Patients in the experimental group will receive Huaier Granule (20g/time, 3 times/d). Patients in the control group will receive placebo (20g/time, 3 times/d). The registration study plan to recruitment at least 300 patients. The primary outcome measures is disease-free survival，secondary outcome measures is 2-year overall survivals, ECOG-performance status, Karnofsky performance score and tumor markers (CEA、CYFRA21-1、SCC).
Interventions
DRUGHuaier Granule
a Chinese traditional medicine
OTHERplacebo
placebo
Sponsors
Qidong Gaitianli Medicines Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 2-year | disease-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 2-year | Quality of Life-EORTC QLQ-C30 |
| KPS | 2-year | Karnofsky |
| ECOG-PS | 2-year | ECOG-PS |
| overall survivals | 2-year | overall survivals |
| CYFRA21-1 | 2-year | tumor markers |
| SCC | 2-year | tumor markers |
| CEA | 2-year | tumor markers |
Countries
China
Outcome results
None listed