The Clinical study of Yiqi Jiedu compound combined with Pembrolizumab in the treatment of non-small cell lung cancer patients with chemotherapy resistance

Phase 1

Recruiting

• Conditions: non-small lung cancer cell, NSCLC

• Registration Number: ITMCTR2000003721
• Lead Sponsor: ongHua Hospital, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Those who met the diagnostic criteria of primary bronchogenic carcinoma and were diagnosed as lung squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma and large cell carcinoma by pathology or cytology;
(2) After conventional platinum chemotherapy, according to RECIST 1.1, the patient suffered from radiologic disease progression determined by the researcher;
(3) After EGFR/ALT-TKIs treatment, according to RECIST 1.1, the patient had the progression of radiologic disease as determined by the investigator;
(4) TCM syndrome differentiation belongs to Qi and yin deficiency, lung and kidney essence deficiency, phlegm and toxin accumulation type;
(5) Aged >= 18 years;
(6) The expected survival time was more than 3 months;
(7) Blood routine test, liver and kidney function, electrocardiogram were basically in the normal range;
(8) Volunteer to participate in clinical research and sign informed consent.

Exclusion Criteria

(1) Patients receiving concurrent radiotherapy, chemotherapy and targeted therapy;
(2) They have been treated with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs.
(3) Patients with interstitial pneumonia and poor lung function;
(4) People with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis and psoriasis;
(5) Those who have undergone organ and hematopoietic stem cell transplantation;
(6) Pregnant or lactating patients;
(7) Patients with mental history.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
median survival time, MST;progression-free survival, PFS;

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate, DCR;Security indicator;Quality of life;Duration of disease control, DDC;Immune indicators;