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

NCT02929693 | Unknown Phase 3 DMC

• 1 other identifier: SHUTCM
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief 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

Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Time from start of the study treatment to date of objective tumour progression (excluding clinical deterioration without evidence of objective progression).

  2 months

Secondary Outcomes (4)

• Overall survival (OS)

  2 months

• Objective response rate (ORR)

  2 months

• Quality of life (QOL)

  2 months

• Safety assessment evaluated according to Common Toxicity Criteria

  2 months

Study Arms (2)

combination

EXPERIMENTAL

YYJD plus gefitinib

Drug: gefitinib; Drug: Yiqi-yangyin-jiedu decoction

controll

PLACEBO COMPARATOR

placebo plus gefitinib

Drug: gefitinib; Drug: placebo

Interventions

gefitinib DRUG

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

Also known as: Iressa

combination; controll

Yiqi-yangyin-jiedu decoction DRUG

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.

Also known as: YYJD

combination

placebo DRUG

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.

Also known as: control

controll

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically or cytologically confirmed stage IIIa-IV pulmonary adenocarcinoma;
• With activating EGFR mutation (either exon19del or exon21L858R) and one month of gefitinib as first-line or second-line therapy without disease progression (PD);
• With TCM diagnostic pattern Qin-and-yin dificiency;
• Age ≥18 years old;
• Estimated life expectancy of at least 12 weeks;
• Without major organ dysfunction: hemoglobin ≥9 g/dL, absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥100 \*109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable with liver metastasis).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;

You may not qualify if:

• with other malignant tumor except NSCLC 5 years previous to study entry;
• PD after onee month of gefitinib treatment
• Estimated life expectancy less than 12 weeks;
• Brain metastasis with relevant symptoms
• History of cardiovascular disease: Congestive Heart Failure \> grade II in NYHA.Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months;
• Pregnant or child breast feeding women;
• Mental or cognitive disorders;

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Shanghai Chest Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

MeSH Terms

Conditions

Neoplasms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2016
• First Posted: October 11, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share