Effect of Astragalus-based Formula: Qingshu-Yiqi-Tang on Modulating Immune Alterations in Lung Cancer Patients (QSYQT)
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: Astagalus-based Formula: Qingshu-Yiqi-Tang |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Progression-free interval [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01802021 History of Changes |
| Other Study ID Numbers: | 97-1967A3 |
| Study First Received: | February 27, 2013 |
| Last Updated: | February 28, 2013 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Chang Gung Memorial Hospital:
|
chinese medicine non-small cell lung cancer immunosuppression |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 28, 2016