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

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

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).

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.