NCT01802021

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 1, 2013

Status Verified

April 1, 2009

Enrollment Period

4.6 years

First QC Date

February 27, 2013

Last Update Submit

February 28, 2013

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

chinese medicinenon-small cell lung cancerimmunosuppression

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 years

Secondary Outcomes (1)

  • Progression-free interval

    3 years

Other Outcomes (1)

  • Quality of Life

    3 years

Study Arms (2)

Qingshu-Yiqi-Tang+standard therapy

EXPERIMENTAL

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

1st line doublet chemotherapy

NO INTERVENTION

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.

Interventions

Astagalus-based Formula: Qingshu-Yiqi-TangDRUG

Plus astragalus-based formula: Qingshu-Yiqi-Tang 7.2gm BID during 1st line chemotherapy and 2nd line target therapy. maximal for 6 months

Also known as: Chuang Song Zong Pharmaceutical Co., Ltd. Taiwan., CHING SHUU YIH CHIH TANG /QING SHU YI QI TANG
Qingshu-Yiqi-Tang+standard therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pathological diagnosis of primary non-small-cell lung cancer Stage IIIB, IV
  • Age ≧ 18 years
  • Written, informed consent
  • ECOG: 0-1

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for traditional chinese medicine, Chang Gung Memorial Hospital

Gueishan Township, Taoyuan County, 33378, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Tse-Hung Huang, M.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 1, 2013

Study Start

May 1, 2009

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

March 1, 2013

Record last verified: 2009-04

Locations

TW(1)