Overview

Effect of Astragalus-based Formula: Qingshu-Yiqi-Tang on Modulating Immune Alterations in Lung Cancer Patients

Status:
Unknown status

Trial end date:
2014-02-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chang Gung Memorial Hospital

Criteria

Inclusion Criteria:

1. Patients with pathological diagnosis of primary non-small-cell lung cancer Stage IIIB,
IV

2. Age ≧ 18 years

3. Written, informed consent

4. ECOG: 0-1

Exclusion Criteria:

1. Subjects with inflammatory, infectious or immune disorder, such as TB, AIDS, active
pneumonia, DM, SLE, rheumatoid disease.

2. Subjects with systemic organ disease, such as CHF, ESRD, hepatitis, liver cirrhosis.

3. Subjects with malignancy other than NSCLC.

4. Subjects receiving anti-inflammatory or immunosuppressor medications, such as steroid
(oral, except for chemotherapy premedication, or inhaled), NSAIDs.

5. Patients with no willing to sign the informed consent