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.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: placebo; Drug: Huaier Granule

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).

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Du Ying Ying

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qidong Gaitianli Medicines Co., Ltd
• Investigators: Principal Investigator: guoping sun, doctor, The First affiliated Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): November 23, 2017
• Study Completion (Actual): November 23, 2017

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence
• Other Study ID Numbers: HE-201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No