Effect of Astragalus-based Formula: Qingshu-Yiqi-Tang on Modulating Immune Alterations in Lung Cancer Patients (QSYQT)
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ClinicalTrials.gov Identifier: NCT01802021 |
Recruitment Status : Unknown
Verified April 2009 by Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : March 1, 2013
Last Update Posted : March 1, 2013
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The myeloid-derived suppressor cells (MDSCs) can further trigger cytotoxic T cell apoptosis, and may shift the macrophages toward M2 subtype, inhibit the Th1 cell, and initiate other immune suppressive mechanism. The functions of NK cells and regulatory T cells are altered, resulting in a disturbance of anti-tumor immune function. All these can further create an environment with a benefit for malignant cell growth and advancement. Astragalus-based formula may confer its survival advantage in cancer patients through modulating the immune system and reversing the immunosuppressive microenvironment.
The investigators aim to study the role of Qingshu-Yiqi-Tang in reversing the immune alterations in patients with advanced stage, non-small cell lung cancer who receive 1st line doublet chemotherapy of cisplatin plus doxetaxel(or Pemetrexed for adenocarcinoma)and 2nd line target therapy of erlotinib. The investigators can explore the possible mechanism of the Astragalus-based formula: Qingshu-Yiqi-Tang in modulating and reversing immunosuppression in advanced stage, non-small cell lung cancer patients.
Condition or disease | Intervention/treatment | Phase |
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Carcinoma, Non-Small-Cell Lung | Drug: Astagalus-based Formula: Qingshu-Yiqi-Tang | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Efficacy Study of Chinese Medicine on Modulating Immune Alterations in Advanced Stage, Non-small Cell Lung Cancer Patients Receiving 1st Line Doublet Chemotherapy and 2nd Line Target Therapy |
Study Start Date : | May 2009 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
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Experimental: Qingshu-Yiqi-Tang+standard therapy
Plus astragalus-based formula: Qingshu-Yiqi-Tang 7.2gm BID during 1st line chemotherapy and 2nd line target therapy, maximal for 6 months. 1st line doublet chemotherapy: Cisplatin 70 mg/m2+Taxotere 60 mg/m2 D1/Q3W x 6 cycles, and then 2nd line target therapy: Erlotinib 150mg QD. |
Drug: Astagalus-based Formula: Qingshu-Yiqi-Tang
Plus astragalus-based formula: Qingshu-Yiqi-Tang 7.2gm BID during 1st line chemotherapy and 2nd line target therapy. maximal for 6 months Other Names:
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No Intervention: 1st line doublet chemotherapy
1st line doublet chemotherapy: Cisplatin 70 mg/m2+Taxotere 60 mg/m2 D1/Q3W x 6 cycles, and then 2nd line target therapy: Erlotinib 150mg QD.
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- overall survival [ Time Frame: 3 years ]
- Progression-free interval [ Time Frame: 3 years ]
- Quality of Life [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with pathological diagnosis of primary non-small-cell lung cancer Stage IIIB, IV
- Age ≧ 18 years
- Written, informed consent
- ECOG: 0-1
Exclusion Criteria:
- Subjects with inflammatory, infectious or immune disorder, such as TB, AIDS, active pneumonia, DM, SLE, rheumatoid disease.
- Subjects with systemic organ disease, such as CHF, ESRD, hepatitis, liver cirrhosis.
- Subjects with malignancy other than NSCLC.
- Subjects receiving anti-inflammatory or immunosuppressor medications, such as steroid (oral, except for chemotherapy premedication, or inhaled), NSAIDs.
- Patients with no willing to sign the informed consent

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): NCT01802021
Taiwan | |
Center for traditional chinese medicine, Chang Gung Memorial Hospital | Recruiting |
Gueishan Township, Taoyuan County, Taiwan, 33378 | |
Contact: Tse-Hung Huang, M.D. +886-3196200 ext 2613 tsehunghuang_1089@yahoo.com.tw | |
Principal Investigator: Tse-Hung Huang, M.D. |
Principal Investigator: | Tse-Hung Huang, M.D. | Chang Gung Memorial Hospital |
Responsible Party: | Chang Gung Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT01802021 |
Other Study ID Numbers: |
97-1967A3 |
First Posted: | March 1, 2013 Key Record Dates |
Last Update Posted: | March 1, 2013 |
Last Verified: | April 2009 |
chinese medicine non-small cell lung cancer immunosuppression |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |