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Clinical Study of YYJD Decoction Combined With Gefitinib in Advanced Pulmonary Adenocarcinoma

NCT02929693 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2019-04-11

No results posted yet for this study

Summary

The investigators performed a multi-centered, randomized, double blinded, placebo-controlled, prospective clinical trial on the effect of Yiqi-yangyin-jiedu decoction (YYJD), a chinese herbal medicine (CHM) formula combined with gefitinib to prolong the progression free survival (PFS) of advanced pulmonary adenocarcinoma patients with activating EGFR mutation (exon19del or exon21L858R). The investigators plan to enroll 198 cases in 3 years (99 cases for gefitinib, 99 cases for gefitinib plus YYJD), expecting that combination therapy has a better efficacy on prolonging PFS, overall survival, improving quality of life(QOL).

Conditions

Interventions

DRUG

gefitinib

250 mg oral once a day until progression or unacceptable toxicity develops

DRUG

Yiqi-yangyin-jiedu decoction

Yiqi-yangyin-jiedu decoction is a traditional chinese herbal medicine formula,and should be taken one package, twice a day, until progression or unacceptable toxicity develops.

DRUG

placebo

Oral granules, which the taste and smell are similar to YYJD, has no therapeutic effect, Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, one package, twice a day, until progression or unacceptable toxicity develops.

Sponsors & Collaborators

  • Shanghai Chest Hospital

    collaborator OTHER

  • Shanghai Pulmonary Hospital, Shanghai, China

    collaborator OTHER

  • Shanghai University of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-06-30
Completion
2019-06-30

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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 NCT02929693 on ClinicalTrials.gov