First-line extensive-stage small cell lung cancer
Conditions
Interventions
Experimental group (climbing tolerance test):1. Toripalimab 240mg, intravenous infusion on day 1, every 21 days for a treatment cycle
2. Lithium carbonate: oral administration, dose from 300mg/ day to 900mg/ day, 21 days per cycle, continuous medication, initial exploratory dose of 600mg/ day.
3. Chemotherapy regimen
1) Etoposide in
The course of treatment was used in the induction stage, and 4-6 cycles were used until the end of the induction period or until the disease progression or intolerance during the induction period.
2)
Or cisplatin: 75 mg/m2IV, D1
The duration of medication was used during the induction phase, with a maximum of 4-6 cycles until the end of the induction period or until the disease progression or into
The test group (dose expansion trial):After determining the lithium carbonate RP2D, 39 patients were enrolled in the dose-expansion phase. According to the evaluation of the investigators at this stag
Sponsors
Shandong First Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signing informed consent; 2. Age >=18 years old; 3. SCLC confirmed by histology or cytology (according to needle biopsy, or/and bronchoscopy, etc.), and diagnosed as ED-SCLC by imaging examination, etc., or patients who progressed after radical treatment for 6 months; 4. No previous systemic treatment; 5. ECOG performance status score 0-1; 6. A life expectancy of at least 12 weeks; 7. Patients must have measurable disease; 8. Other major organs (liver, kidney, thyroid, blood system, etc.) function well; 9. Women of childbearing age must have a negative pregnancy test within 7 days before starting treatment; Use of a reliable contraceptive method (e.g., intrauterine devices, birth control pills, and condoms) for 180 days before and after the trial; 10. Male participants of reproductive age should use condoms during the trial and for 180 days after the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with any of the following cannot be enrolled in this study 2. Patients with malignancies other than SCLC within five years before the start of this trial; 3. Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc.; 4. Active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic treatment; 5. Allergy to the test drug; 6. Have or currently have interstitial lung disease; 7. Combined with HIV infection or active viral hepatitis; 8. Pregnant or breastfeeding women; 9. Any malabsorption; 10. Those who suffer from neurological diseases or mental illnesses and cannot cooperate; 11. Patients using diuretics; 12. Situations that other researchers consider unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD);Dose-limiting toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Overall Survival (OS);6-month PFS rate;Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactWang Haiyong
Shandong First Medical University Affiliated Tumor Hospital
Outcome results
None listed