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

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Huaier Granule
placebo
Sponsored by
Qidong Gaitianli Medicines Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Du Ying Ying

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Huaier Granule

placebo

No-treatment Control

Arm Description

Huaier Granule

placebo

patients refused any treatment

Outcomes

Primary Outcome Measures

disease-free survival
disease-free survival

Secondary Outcome Measures

overall survivals
overall survivals
Quality of Life
Quality of Life-EORTC QLQ-C30
KPS
Karnofsky
ECOG-PS
ECOG-PS
CEA
tumor markers
CYFRA21-1
tumor markers
SCC
tumor markers

Full Information

First Posted
May 31, 2017
Last Updated
March 5, 2020
Sponsor
Qidong Gaitianli Medicines Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03198117
Brief Title
Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in patient recruitment
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
November 23, 2017 (Actual)
Study Completion Date
November 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qidong Gaitianli Medicines Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Huaier Granule
Arm Type
Experimental
Arm Description
Huaier Granule
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
No-treatment Control
Arm Type
No Intervention
Arm Description
patients refused any treatment
Intervention Type
Drug
Intervention Name(s)
Huaier Granule
Intervention Description
a Chinese traditional medicine
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
disease-free survival
Description
disease-free survival
Time Frame
2-year
Secondary Outcome Measure Information:
Title
overall survivals
Description
overall survivals
Time Frame
2-year
Title
Quality of Life
Description
Quality of Life-EORTC QLQ-C30
Time Frame
2-year
Title
KPS
Description
Karnofsky
Time Frame
2-year
Title
ECOG-PS
Description
ECOG-PS
Time Frame
2-year
Title
CEA
Description
tumor markers
Time Frame
2-year
Title
CYFRA21-1
Description
tumor markers
Time Frame
2-year
Title
SCC
Description
tumor markers
Time Frame
2-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
guoping sun, doctor
Organizational Affiliation
The First Affiliated Hospital of Anhui Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Du Ying Ying
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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