Extensive-stage SCLC
Conditions
Interventions
Huatan Jiedu No.2 decoction group control group:Placebo
Huatan Jiedu No.2 decoction group:Huatan Jiedu No. 2 Prescription
Huatan Jiedu prescription group:Huatan Jiedu decoction granules
Huatan Jiedu decoction group control group:Placebo
Sponsors
Cancer Hospital Chinese Academy for Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: 1) Age of 18-75 years old; 2) ECOG or PS score 0-1 predicted survival time =3 months; 3) Small cell lung cancer (SCLC) confirmed by histopathology or cytopathology with extensive stage according to the American Legion Lung Association guidelines; 4) Huatan Jiedu decoction group without previous anti-tumor treatment; 5) TCM syndrome differentiation is phlegm poisoning syndrome; 6) at least one measurable tumor lesion (diameter > 1cm); 7) Subjects voluntarily participated in this study signed the informed consent form and the compliance was good
Exclusion criteria
Exclusion criteria: 1: 1) combined with other primary malignant tumors; 2) patients with contraindications to immunotherapy after basic evaluation before immunotherapy; 3) patients with a history of autoimmune diseases or long-term use of systemic steroids or immunosuppressive agents; 4) complicated with serious primary diseases of the heart cerebrovascular liver kidney hematopoietic system; (5) pregnant women lactating women patients with mental disorders intellectual and language disorders; 6) Unable to cooperate with the baseline assessment; 7) Using other Chinese medicine or Chinese patent medicine preparation; 8) With multiple factors affecting oral medication (such as inability to swallow intestinal obstruction etc.) or with oral allergy history contraindication or intolerance to the main components of Huatan Jiedu prescription or Huatan Jiedu No. 2 prescription; 9) participated in other drug clinical trials within 4 weeks before randomization (the washout period was calculated from the end of the last treatment); 10) According to the investigator's judgment those who have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study or those who are considered to be unsuitable for the study for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor Marker;OS;ORR;DoT;LCSS and ECOG scores;DCR;The incidence of immune-related adverse reactions;Testing of Immunolbgical Index;Measures of energy metabolism; | — |
Countries
China
Contacts
Public ContactYukun Yin
Cancer Hospital Chinese Academy for Medical Sciences
Outcome results
None listed