Small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All of the following criteria must be met in order to be included in the test (1) Age =18 years old, gender unlimited; (2) Patients with small cell lung cancer confirmed by histology or cytology according to the CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (2022 edition); (3) Measurable lesions that meet RECIST v1.1 criteria for evaluation; (4) Receiving standard first-line chemotherapy regimen (4 cycles) recommended by the CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (2022 edition); (5)ECOG score 0-1; (6) Expected survival of more than 6 months; (7) Agree to participate in the clinical trial and voluntarily sign the informed consent;
Exclusion criteria
Exclusion criteria: All of the following criteria must not be met in order to be included in the test (1) Clinically significant abnormal liver function, i.e., glutamic oxalacetic transaminase or alanine transaminase > 2.5 times the upper limit of normal, total serum bilirubin level > 1.5 times the upper limit of normal; (2) Clinically significant renal insufficiency, that is, serum creatinine > 1.5 times the upper limit of normal; (3) Patients with severe heart disease, i.e., patients with NYHA cardiac dysfunction rated ?-?; Unstable angina pectoris or myocardial infarction within 6 months; (4) Patients with splenectomy or other severe hematopoietic diseases; (5) Patients with uncontrolled diabetes mellitus, hypertension (systolic blood pressure > 180mmHg and/or diastolic blood pressure > 120mmHg), uncontrolled infections, and severe gastrointestinal ulcer disease; (6) Previous or current history of cancer other than lung cancer, other than cured non-melanoma skin cancer, cervical carcinoma in situ, and other cancers that have been cured for at least 5 years; (7) Mental illness patients without self-awareness, without legal capacity or limited legal capacity; (8) Patients who are pregnant, lactating or have the possibility of becoming pregnant or plan to become pregnant; (9) There are currently events in which the study drug cannot be taken orally (such as dysphagia, chronic diarrhea, intestinal obstruction, etc.); (10) Have participated in or are participating in other clinical researchers within the past 3 months; (11) The researchers thought there were any other ineligible candidates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Score of EORTC QLQ-C30 scale;Lung cancer Symptom Scale LCSS score;Pain (VAS score);Tumor marker;Classification and Evaluation of Common Toxic and Side Effects of Anticancer Drugs (CTCAE-V4.0); | — |
Countries
China
Contacts
Department of Respiratory and Critical Care Medicine, Seventh Medical Center, PLA General Hospital