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Trial record 2 of 247989 for:    ALL

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Qidong Gaitianli Medicines Co., Ltd Identifier:
First received: May 31, 2017
Last updated: June 21, 2017
Last verified: May 2017
This study including two parts,one part is a randomized clinical trial design,another part is a registration study.

Condition Intervention
Non-small Cell Lung Cancer Drug: Huaier Granule Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Qidong Gaitianli Medicines Co., Ltd:

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

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

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

  • KPS [ Time Frame: 2-year ]

  • ECOG-PS [ Time Frame: 2-year ]

  • CEA [ Time Frame: 2-year ]
    tumor markers

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

  • SCC [ Time Frame: 2-year ]
    tumor markers

Estimated Enrollment: 798
Actual Study Start Date: April 25, 2017
Estimated Study Completion Date: June 1, 2022
Estimated Primary Completion Date: June 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Huaier Granule
Huaier Granule
Drug: Huaier Granule
a Chinese traditional medicine
Placebo Comparator: placebo
Other: placebo
No Intervention: No-treatment Control
patients refused any treatment

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).


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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT03198117

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

Responsible Party: Qidong Gaitianli Medicines Co., Ltd Identifier: NCT03198117     History of Changes
Other Study ID Numbers: HE-201701
Study First Received: May 31, 2017
Last Updated: June 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Disease Attributes
Pathologic Processes processed this record on June 23, 2017