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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003721
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small lung cancer cell, NSCLC

Interventions

Sponsors

LongHua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
median survival time, MST;progression-free survival, PFS;

Secondary

MeasureTime frame
Disease Control Rate, DCR;Security indicator;Quality of life;Duration of disease control, DDC;Immune indicators;

Countries

China

Contacts

Public ContactJia Yang

LongHua Hospital, Shanghai University of Traditional Chinese Medicine

jiajiayy07@163.com+86 18817338807

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026