SCLC
Conditions
Interventions
experimental group:Tirelizumab combined with antinib
Sponsors
Fujian Province Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects volunteered to join the study and signed the informed consent form, with good compliance and follow-up cooperation; 2. Male or female patients aged 18-75 years; 3. Patients with small cell lung cancer confirmed by histology or cytology who had previously failed to receive first-line chemotherapy with platinum containing two drugs had at least one measurable lesion; 4. The time interval between the disease progression and the end of the last systemic chemotherapy is less than 3 months, that is, the patients with refractory SCLC; 5. Patients with life expectancy >= 12 weeks, ECoG score: 0-1; 6. Patients with normal function of main organs meet the following standards: (1) The blood routine examination standard should be in accordance with (no blood transfusion and blood products, no correction with G-CSF and other hematopoietic stimulating factors in the first 14 days): Hemoglobin (HB) >= 90 g / L; Neutrophil absolute value (ANC) >= 1.5 * 10^9 / L (1500 / m3); Platelet count (PLT) >= 80 * 10^9 / L; (2) Biochemical examination shall meet the following standards: TBIL = 50 ml / min (Cockcroft Gault formula: CrCl (ml / min) = [(140 age) * weight (kg) * F] / (SCR (mg / dl) * 72). Among them, f = 1 for men, f = 0.85 for women, and SCR = serum creatinine) 7. Patients assessed by Doppler ultrasound: left ventricular ejection fraction (LVEF) >= lower limit of normal value (50%); 8. Women of childbearing age must have taken reliable contraceptive measures or carried out pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of the test drug. For men, it must be agreed that appropriate methods of contraception or sterilisation have been carried out during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously used enrotinib hydrochloride capsules or other anti angiogenic drugs; 2. Patients who have previously received antibodies or drugs through targeted immune checkpoints, including but not limited to anti-PD-1, anti-PD-L1 or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibodies; 3. Within 4 weeks before randomization or within 5 half lives of the drug (whichever is longer), use of systemic immunomodulators (including but not limited to interferon, interleukin-2, tumor necrosis factor) for treatment (allowing the use of cancer vaccine in previous treatment); 4. Imaging (CT or MRI) showed the presence of pulmonary cavity tumor; 5. History and complications (1) Patients with symptomatic brain metastasis, cancerous meningitis, spinal cord compression, or imaging CT or MRI at screening Brain or PIA diseases were found in the examination (patients with brain metastasis who had completed treatment 4 weeks before admission and whose symptoms were stable and no progress could be admitted to the group, but no cerebral hemorrhage was confirmed by brain MRI, CT or venography); (2) Patients are participating in other clinical studies (excluding non intervention studies) or less than 4 weeks from the end of the previous clinical study; (3) Chemotherapy, radiotherapy or other experimental anticancer therapy (except bisphosphonates) has been received within 4 weeks before the first dose of experimental drug treatment: those who have previously received local radiotherapy can be included in the group if the following conditions are met: the end of radiotherapy is more than 4 weeks from the beginning of study treatment (more than 2 weeks for brain radiotherapy); and the target focus selected in this study is not in the radiotherapy area; or the target focus Located in the radiotherapy area, but progress has been confirmed; (4) In the past 2 years, there have been or are currently suffering from other malignant tumors, except for the cured carcinoma in situ of cervix, skin cancer of non melanoma and superficial bladder tumor [ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; (5) Patients with active, known or suspected autoimmune diseases, including the history of allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation, HIV positive history or acquired immunodeficiency syndrome (AIDS) history. (6) Active or previously documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). (7) Any disease requiring systemic treatment with corticosteroids (prednisone > 10 mg / day or equivalent) or other immunosuppressive drugs within 14 days prior to randomization. Note: patients who currently or previously used any of the following steroid regimens may be included: Adrenaline replacement steroids (prednisone 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolys
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease contral rate;One-year survival rate;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactZhuang Wu
Fujian Province Cancer Hospital
Outcome results
None listed