Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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This study including two parts，one part is a randomized clinical trial design，another part is a registration study.

Detailed Description
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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).

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Huaier Granule
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Huaier Granule<br>Huaier Granule | Drug: Huaier Granule<br>* a Chinese traditional medicine<br>|
| Placebo Comparator: placebo<br>placebo | Other: placebo<br>* placebo<br>|
| No Intervention: No-treatment Control<br>patients refused any treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | disease-free survival | 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survivals | overall survivals | 2-year | 
| Quality of Life | Quality of Life-EORTC QLQ-C30 | 2-year | 
| KPS | Karnofsky | 2-year | 
| ECOG-PS | ECOG-PS | 2-year | 
| CEA | tumor markers | 2-year | 
| CYFRA21-1 | tumor markers | 2-year | 
| SCC | tumor markers | 2-year |