NCT02889692

Clinical Study of Chinese Medicine Plus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma

Study of Chinese Medicine Plus Targeted Therapy Maintenance Versus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma: A Randomized Double-blind Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators performed a randomized, double blind controlled, prospective study method on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy maintenance to prolong the efficacy of long-term survival of advanced pulmonary adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3 years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy maintenance plus TCM,), expecting that integrated TCM combined with targeted maintenance therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of targeted maintenance therapy.

Detailed description

Maintenance therapy refers to systemic therapy that may be given for patients with advanced NSCLC after 4 to 6 cycles of first-line chemotherapy. However, patients are only candidates for maintenance therapy if they have responded to their previous treatment or have stable disease and their tumors have not progressed. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFRTKIs) such as Iressa and Erlotinib have proved effective in first or second line therapy for advanced pulmonary adenocarcinoma. Targeted therapy maintenance can be partly extend patient's TTP, but the toxicity and the side effects of targeted therapy will decrease QOL. Besides, high cost of targeted therapy will cause greater economic pressure on patients.The investigators' preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival time and improve QOL, but high-level evidences are needed. The investigators perform a multicenter, randomized, double blind controlled, prospective study in advanced pulmonary adenocarcinoma patients with stage Ⅲ～Ⅳ. Advanced pulmonary adenocarcinoma patients after first-line chemotherapy will choose maintenance therapy according to the patient's wishes, including targeted therapy maintenance, chemotherapy maintenance and TCM maintenance therapy. Patients who choose targeted therapy maintenance are randomized over observational group (TCM granules plus targeted therapy maintenance),and control group (TCM placebo plus targeted therapy maintenance). The treatment should be continued until evidence of disease progression or unacceptable toxicity, and after that regular follow-up will be arranged. The primary efficacy assessments are: OS (overall survival); Secondary efficacy assessments are: (1) PFS (progression-free survival); (2) Objective response rate; (3) QOL (Functional Assessment of Cancer therapy-lung, FACT-L4.0 scales; Lung Cancer Symptom Scale, LCSS); (4) other efficacy assessments are: 1) TCM symptoms changes; 2) Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with targeted therapy maintenance has a better efficacy on prolonging progression-free survival time, overall survival, improving QOL of patients than that of targeted therapy maintenance. Therefore the study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	YiQiFang	Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiFang: Patients with Qi deficiency syndrome are administered two packages of each benefiting Qi and detoxication recipe, four packages, twice a day, until progression or unacceptable.
DRUG	YangYinFang	Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YangYinFang: Patients with Yin deficiency syndrome are administered two packages of each benefiting Yin and detoxication recipe, four packages, twice a day, until progression or unacceptable.
DRUG	YiQiYangYinFang	Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiYangYinFang: Patients with Qi and Yin deficiency syndrome are administered one package of each benefiting Qi and benefiting Yin and two packages of detoxication recipe, four packages, twice a day, until progression or unacceptable.
DRUG	placebo granules	Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, four packages, twice a day, until progression or unacceptable.
DRUG	Erlotinib®	"Erlotinib®","tarceva", 150 mg oral once a day until progression or unacceptable toxicity develops.
DRUG	Gefitinib®	"Gefitinib®","Iressa", 250 mg oral once a day until progression or unacceptable toxicity develops.
DRUG	Icotinib®	"Icotinib®","Conmana" 125 mg oral three times a day until progression or unacceptable toxicity develops.

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-12-30
• Completion: 2017-06-01
• First posted: 2016-09-05
• Last updated: 2019-04-11