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Efficacy Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma

NCT01745302 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 470

Last updated 2016-07-13

No results posted yet for this study

Summary

The investigators performed a randomized, double-blind controlled, prospective study method on observation of Traditional Chinese Medicine combined with targeted therapy to prolong the efficacy of long-term survival of advanced pulmonary Adenocarcinoma patients.The investigators plan to involve 404 cases for observation in 3 years (202 cases for each group), expecting that integrated TCM combined with targeted therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving QOL of patients than that of targeted therapy.

Conditions

Interventions

DRUG

TCM

TCM: In China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.The herbal treatment is adapted to the syndromes.

DRUG

EGFR-TKI

Erlotinib 150 mg oral once a day or Gefitinib 250 mg oral once a day or Icotinib 125 mg oral three times a day

Sponsors & Collaborators

  • Shanghai Chest Hospital

    collaborator OTHER

  • Shanghai University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Ling Xu, MD & PhD · Longhua Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01745302 on ClinicalTrials.gov