Small Cell Lung Cancer with Brain Metastasis
Conditions
Interventions
Clinical trial group:Whole brain radiotherapy combined with tislelizumab and chemotherapy
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed an informed consent form; 2. Age is greater than 18 years old (including the threshold, calculated based on the date of signing informed consent), and less than or equal to 70 years old, both male and female are acceptable; 3. Small cell lung cancer confirmed by cytology or histopathology; 4. Patients who have at least 1 measurable lesion >= 5mm in the intracranial region with initially diagnosed brain metastases or who have brain metastases after systemic treatment; 5. ECOG physical condition 0-2 points; 6. Expected survival >= 12 weeks; 7. The organ function of the patient is normal within 7 days before receiving treatment, and the functions of important organs meet the following requirements: (1) Blood routine test: WBC >= 3.5 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L, hemoglobin >= 90 g/L; (2) International standardized ratio (INR) = 60 mL/min (see appendix); (5) Cardiac function is normal, and the left ventricular ejection fraction (LVEF) measured by two-dimensional echocardiography is >= 50%; 8. Male or female patients with fertility voluntarily use effective contraceptive methods such as dual barrier contraception, condoms, oral or injectable contraceptives, and intrauterine devices during the study period and within 6 months of the last study medication. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (such as hysterectomy, bilateral appendectomy, or radiation ovarian irradiation); Otherwise, the female patient's serum indicates that she was not pregnant within 7 days before the study and must be a non lactating patient; 9. Be able to conduct oral medication in accordance with the research protocol and visit process.
Exclusion criteria
Exclusion criteria: 1. The patient has previously received immunocheckpoint inhibitor treatment; 2. Have received approved or under research systemic immunotherapy, targeted therapy, and traditional Chinese medicine treatment within 2 weeks before enrollment. (However, the manual contains Chinese medicine treatment with clear anti-tumor indications, which can also be included in the group after a 2-week washout period); 3. Participated in clinical trials of other drugs that have not yet been approved or listed in China and received corresponding trial drug treatment within 2 weeks before enrollment; 4. Excessive surgery performed within 4 weeks before enrollment (tissue biopsy and central venous catheter insertion through peripheral vein puncture [PICC]/infusion port implantation required for diagnosis are allowed); 5. The subject has previously or simultaneously suffered from other malignant tumors (except for other malignant tumors that have been cured such as skin basal cell carcinoma, cervical carcinoma in situ, and breast ductal carcinoma in situ (DCIS), and have been fully treated and cured for >= 5 years before enrollment, with evidence that there is no recurrence or metastasis); 6. Patients with acute cerebral infarction and cerebral hemorrhage; 7. The patient currently has hypertension that cannot be controlled by drugs, which is defined as: systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 90 mmHg; 8. Tumor histology or cytological pathology confirms the presence of non small cell lung cancer, large cell neuroendocrine carcinoma components, or sarcomatoid lesions; 9. The patient currently has any disease or condition that affects drug absorption; 10. Persons who are known to be contraindicated to intracranial radiation therapy or allergic to the active components of tirelizumab and its excipients. 11. Patients with an estimated survival time of = ++, and 24-hour urine protein > 1g; 13. Patients with significant evidence of bleeding propensity or medical history within the first 3 months of enrollment (bleeding > 30 mL within 3 months, hematemesis, black stool, and hematochezia), hemoptysis (fresh blood > 5 mL within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months; 14. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass surgery within the first 6 months of enrollment; Congestive heart failure: New York Heart Association (NYHA) rating > 2; Ventricular arrhythmia requiring medication; Electrocardiogram (ECG) showed a QTc interval of >= 480 milliseconds; 15. Active or uncontrolled severe infection (>= CTCAE level 2 infection); 16. Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver diseases, including viral hepatitis [known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positive (> 1 x 10^4 copies/mL or > 2000 IU/mL); Hepatitis C virus infection (HCV) is known and HCV RNA is positive (> 1 x 10^3 copies/mL), or other hepatitis, cirrhosis]; 17. Unremitted toxic reactions that are higher than CTCAE level 1 or higher due to any previous anticancer treatment, excluding hair loss, lymphopenia, and neurotoxicity <= level 2 caused by chemotherapy drugs; 18. Pregnant (positive pregnancy test before medication) or lactating women; 19. Any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intracranial objective response rate, iORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| intracranial disease control rate, iDCR;intracranial duration of disease response, iDoR;intracranial progression-free survival, iPFS;Progression-free survival, PFS;Disease Control Rate, DCR;Quality of Life, QoL;Mini-Mental State Examination, MMSE;Overall Survival, OS;Safety endpoint; | — |
Countries
China
Contacts
Public ContactFeng Wei
Zhejiang Cancer Hospital
Outcome results
None listed