Limited Stage small cell lung cancer
Conditions
Interventions
Test group:Cladribine Chemotherapy Radiotherapy
Cladribine: 240 mg/m2, intravenous infusion over 30 minutes, to be completed within 4 hours before chemotherapy
Etoposide: 100 mg/m2, intravenous infusion, days 1-3, every 3 weeks (Q3W)
Carboplatin: AUC=5, maximum not exceeding 750 mg, intravenous infusion, day 1, every 3 weeks (Q3W)
Chest radiotherapy: 45gy/1.5gy, b.i.d. / 3 weeks
control group:Chemotherapy and Radiotherapy
Etoposide: 100 mg/m2, intravenous infusion, days 1-3, every 3 weeks
Carboplatin: AUC=5, not exceeding 750 mg, intravenous infusion, day 1, every 3 weeks
Thoracic radiotherapy: 45 Gy, 1.5 Gy, b.i.d. / 3 weeks
Sponsors
Liaoning Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate, sign an informed consent form, and are able to comply with the study procedures; 2. Age =18 years at enrollment, both males and females are eligible; 3. Pathologically confirmed (histology or cytology) as limited-stage small cell lung cancer (LS-SCLC); 4. No prior anti-tumor treatment for LS-SCLC; 5. Measurable lesions: For non-lymph nodes, at least one lesion with the longest diameter =1.0 cm, or for lymph nodes, at least one lesion with the short axis diameter =1.5 cm, according to RECIST 1.1, which can be continuously measured using computed tomography/magnetic resonance imaging (CT/MRI). If there is only one target lesion and it is a non-lymph node, its longest diameter should be =1.5 cm. 6. Laboratory tests meet the following criteria: Hemoglobin = 90 g/L Neutrophil count = 1.5×10^9/L Platelet count = 100×10^9/L Creatinine = 15 mg/L or creatinine clearance (CrCl) = 60 mL/min (Cockcroft-Gault formula) Total bilirubin = 1.5× upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3× ULN Albumin = 30 g/L; 7. ECOG performance status 0-2; 8. Females: All women of potential childbearing potential must have a negative serum pregnancy test during the screening period and must use reliable contraception from signing the informed consent until 3 months after the last administration; Males: If the female partner is of potential childbearing potential, reliable contraception must be used from signing the informed consent until 3 months after the last administration.
Exclusion criteria
Exclusion criteria: 1. Refusal to sign the informed consent form or refusal to follow up; 2. Medical contraindications to chemotherapy based on etoposide-platinum (carboplatin or cisplatin); 3. Allergy to the investigational drug tralesin or any of its components; 4. Clinically assessed as surgically resectable and the patient voluntarily agrees to undergo surgical resection; 5. Previously received approved or investigational biological immunotherapy, targeted therapy, or Chinese medicine treatment (Chinese medicine treatments with clear anti-tumor indications in the instructions are allowed, and a 1-week washout period is also acceptable); 6. Received hematopoietic growth factor, blood transfusion, or platelet transfusion within one week before the blood test during the screening period; 7. Presence of any active autoimmune disease or history of autoimmune disease; 8. Systemic use of corticosteroids (daily >10mg prednisone or equivalent) or other immunosuppressants (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks before the first administration; 9. Patients with active/refractory infection requiring ongoing anti-infective treatment; 10. Severe cardiovascular damage (history of congestive heart failure greater than NYHA class II), unstable angina or myocardial infarction within the past 6 months, or severe arrhythmias. QTcF >480 msec at screening; for patients with implanted ventricular pacemakers, QTcF >500 msec; 11. Stroke or cardiovascular/cerebrovascular events within 6 months before enrollment; 12. Subjects who have undergone allogeneic organ transplantation requiring immunosuppressive therapy; 13. Known HIV-positive subjects; 14. Uncontrolled active hepatitis B (defined as screening HBsAg positive and HBV DNA detected above the upper limit of normal at the study center; subjects with HBV DNA <500 IU/mL within 28 days before randomization who have received at least 4 weeks of standard local antiviral treatment and are willing to continue antiviral treatment during the study may be enrolled); active hepatitis C (defined as screening HCV antibody positive and HCV RNA positive); 15. Previous history =5 years of other malignant tumors, fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer post-radical surgery, or ductal carcinoma in situ post-radical surgery are not excluded; 16. Live vaccine administered within 30 days prior to the first study treatment; 17. Any medical condition that the investigator considers makes the subject unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade = 3 neutropenia during chemotherapy treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of grade = 3 neutropenia in the first cycle of chemotherapy (DSN);Incidence of grade = 3 thrombocytopenia;Recombinant human interleukin-11 and / or thrombopoietin (TPO) use rates;Incidence of platelet transfusion;Incidence of grade 3 anemia during chemotherapy treatment;Erythropoietin (ESA) use rate;Incidence of RBC transfusion (week 5 and later);Granulocyte colony stimulating factor (G-CSF) use rate;;Incidence of AE and serious adverse event (SAE) assessed by NCI CTCAE (version 5.0);Objective response rate of tumors;Disease control rate;progression free survival;overall survival; | — |
Countries
Chian
Contacts
Public ContactJinghui Bai
Liaoning Cancer Hospital
Outcome results
None listed