Resectable stage IB-IIIB non-small cell lung cancer (NSCLC) with chronic pain
Conditions
Interventions
experimental group:Rimegepant Sulfate Combined with Camrelizumab and Chemotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join this study and sign the informed consent form; 2. Age >= 18 years and = 1.5 x 10^9/L; (2) Platelets >= 100 x 10^9/L; (3) Hemoglobin >= 90 g/L; (4) Serum albumin >= 30 g/L; (5) Thyroid-stimulating hormone (TSH) <= 1 x ULN (if abnormal, also check FT3 and FT4; if FT3 and FT4 are normal, can enroll); (6) Total serum bilirubin <= 1.5 x ULN; (7) ALT and AST <= 2.5 x ULN, if liver metastasis is present, ALT and AST <= 5 x ULN; (8) ALP <= 2.5 x ULN; (9) Serum creatinine <= 1.5 x ULN; (10) INR <= 1.5 (without anticoagulant therapy); 9. Non-sterilized or childbearing-age female patients must use a medically recognized contraceptive method (e.g., IUD, birth control pills, or condoms) during and for 3 months after the study treatment; for non-sterilized childbearing-age females, serum or urine HCG test must be negative within 7 days before first dose; must not be breastfeeding; for male patients with partners of childbearing age, effective contraception must be used during the trial and for 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Having any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; vitiligo or childhood asthma that has fully resolved and requires no treatment in adulthood can be included; asthma requiring medical intervention with bronchodilators cannot be included); 2. Currently using immunosuppressants or systemic steroid treatment for immunosuppression purposes (dose > 10 mg/day prednisone or equivalent steroids) and continuing use within 2 weeks prior to enrollment; 3. Patients with EGFR or ALK mutations; 4. Previously received systemic treatment for NSCLC (such as chemotherapy, targeted therapy, immunotherapy, etc.); 5. Had severe allergic reactions to other monoclonal antibodies; 6. Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 7. Having or having had other malignant tumors within the past 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 8. Having hypertension that cannot be well controlled with antihypertensive medications (systolic >= 140 mmHg or diastolic >= 90 mmHg); achieving these targets with antihypertensive treatment is allowed; history of hypertensive crisis or hypertensive encephalopathy; 9. Poorly controlled cardiac clinical symptoms or diseases, such as: (1) Heart failure NYHA class 2 or higher; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc > 450 ms (male); QTc > 470 ms (female); 10. Urinalysis showing proteinuria >= ++ and confirmed 24-hour urine protein > 1.0 g; 11. Having an active infection, unexplained fever >= 38.5°C within 7 days before medication, or baseline white blood cell count > 15 x 10^9/L; 12. Having congenital or acquired immune deficiencies (such as HIV infection); HBsAg positive and HBV DNA >= 2000 IU/ml, or positive for hepatitis C antibodies; 13. Vaccinated with live vaccines within 4 weeks prior to study medication or possibly during the study; 14. According to the investigator's judgment, other factors that might affect the study results or cause premature termination, such as alcoholism, drug abuse, other severe diseases (including mental illness) requiring co-treatment, severe lab abnormalities, or family/social factors that could affect patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs);Quality of Life (QoL);Progression-Free Survival (PFS);Pathological Complete Response (pCR);Event-Free Survival (EFS); | — |
Countries
China
Contacts
Public ContactHang Yin
Harbin Medical University Cancer Hospital
Outcome results
None listed