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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03198117
• Other study ID #: HE-201701
• Status: Terminated
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: November 23, 2017

Study information

• Verified date: March 2020
• Source: Qidong Gaitianli Medicines Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 23, 2017
• Est. primary completion date: November 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with complete resection who are at TNM (primary tumor, regional nodes, metastasis) stage II-?a, 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Recurrence

Intervention

Drug:
• Huaier Granule
a Chinese traditional medicine

Other:
• placebo
placebo

Locations

Country	Name	City	State
China	Du Ying Ying	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Qidong Gaitianli Medicines Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	disease-free survival	2-year
Secondary	overall survivals	overall survivals	2-year
Secondary	Quality of Life	Quality of Life-EORTC QLQ-C30	2-year
Secondary	KPS	Karnofsky	2-year
Secondary	ECOG-PS	ECOG-PS	2-year
Secondary	CEA	tumor markers	2-year
Secondary	CYFRA21-1	tumor markers	2-year
Secondary	SCC	tumor markers	2-year