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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03198117
Recruitment Status : Active, not recruiting
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Qidong Gaitianli Medicines Co., Ltd

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Huaier Granule Other: placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 798 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Huaier Granule
Huaier Granule
Drug: Huaier Granule
a Chinese traditional medicine

Placebo Comparator: placebo
placebo
Other: placebo
placebo

No Intervention: No-treatment Control
patients refused any treatment



Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 2-year ]
    disease-free survival


Secondary Outcome Measures :
  1. overall survivals [ Time Frame: 2-year ]
    overall survivals

  2. Quality of Life [ Time Frame: 2-year ]
    Quality of Life-EORTC QLQ-C30

  3. KPS [ Time Frame: 2-year ]
    Karnofsky

  4. ECOG-PS [ Time Frame: 2-year ]
    ECOG-PS

  5. CEA [ Time Frame: 2-year ]
    tumor markers

  6. CYFRA21-1 [ Time Frame: 2-year ]
    tumor markers

  7. SCC [ Time Frame: 2-year ]
    tumor markers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198117


Locations
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China, Anhui
Du Ying Ying
Hefei, Anhui, China, 230022
Sponsors and Collaborators
Qidong Gaitianli Medicines Co., Ltd
Investigators
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Principal Investigator: guoping sun, doctor The First Affiliated Hospital of Anhui Medical University

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Responsible Party: Qidong Gaitianli Medicines Co., Ltd
ClinicalTrials.gov Identifier: NCT03198117    
Other Study ID Numbers: HE-201701
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Recurrence
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pathologic Processes
Disease Attributes