Non-small cell lung cancer
Conditions
Interventions
Group 1:Beta-glucan in combination with Nvorimab and Endostat
Sponsors
Changzhou Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18-80 years old; 2. The subjects volunteered to participate in the trial and signed the informed consent; 3. The expected survival period is more than 3 months; 4. Patients with locally advanced, metastatic or recurrent NSCLC confirmed by histology and/or cytology and who have previously failed PD-1 therapy; 5. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging; 6. ECOG score 0-1 points; 7. Have sufficient organ and bone marrow function; 8. Take reasonable methods of contraception during the medication.
Exclusion criteria
Exclusion criteria: 1. Imaging shows that the tumor invades large blood vessels, or it is judged that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 2. Currently participating in interventional clinical research treatment, or receiving other investigational drug or investigational device treatment within 4 weeks before the first dose; 3. Received Chinese patent medicines with anti-tumor indications or immunomodulatory drugs within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration; 4. Active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis requiring clinical intervention; 5. Allergic reaction to the research drug; 6. Patients requiring long-term systemic corticosteroid use. Patients who require intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroids due to COPD or asthma may be enrolled; 7. Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases or patients with stable brain metastases after treatment were eligible to participate in this study as long as they met all of the following criteria: measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, Medullary or spinal metastases; maintain clinical stability for at least 2 weeks; stop hormone therapy 3 days before the first dose of study drug; 8. Active infection requiring treatment or systemic anti-infective drugs used within one week before the first administration; 9. Has not sufficiently recovered from toxicity and/or complications caused by any intervention prior to initiating treatment; 10. Known history of human immunodeficiency virus (HIV) infection; 11. Untreated active hepatitis B; 12. Active HCV infected subjects; 13. Received live vaccine within 30 days before the first dose (cycle 1, day 1); 14. Pregnant or lactating women; 15. Medical history or disease evidence that may interfere with the test results, prevent subjects from participating in the research throughout the study, abnormal treatment or laboratory test values, or other circumstances that the investigator considers unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;disease control rate;duration of response;overall survival; | — |
Countries
China
Contacts
Public ContactJiang Hua
Changzhou Second People's Hospital
Outcome results
None listed