small cell lung cancer, SCLC
Conditions
Interventions
Test group:Sintilimab + Anlotinib + Albumin Paclitaxel
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign written informed consent before implementing any trial-related procedures; 2.Aged 18 to 75 years; 3.Extensive-stage small cell lung cancer (SCLC) confirmed by histology or cytology; 4.According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there is at least one imaging measurable lesion. The lesions located in the radiation field of the previous radiotherapy can be regarded as measurable lesions if the progress is confirmed; 5.Have received at least first-line or above systemic treatment for SCLC in the past; 6.Subjects with brain metastases asymptomatic or with stable symptoms after local treatment are allowed to be included in the group, as long as the subjects meet the following conditions: (1)There are measurable lesions outside the central nervous system; (2)No symptoms of central nervous system or no worsening of symptoms within at least 2 weeks; (3)No need for glucocorticoid treatment, or stop glucocorticoid treatment within 7 days before enrollment, or the dosage of glucocorticoid is stable and reduced to less than 10mg/day prednisone (or equivalent dose) within 7 days before enrollment; 7.Subjects are allowed to receive palliative radiotherapy (including craniocerebral radiotherapy for symptomatic brain metastases), but the radiotherapy needs to be completed at least 1 week before the first study drug administration, and the radiotherapy-related toxicity is restored to less than or equal to 1 Degree (CTCAE 5.0, except for hair loss); 8.ECOG score 0-1 points; 9.Expected survival time> 3 months; 10.Sufficient organ function, subjects need to meet the following laboratory indicators: (1)The absolute value of neutrophils (ANC) >= 1.5x10^9/L when no granulocyte colony stimulating factor is used in the past 14 days; (2)In the case of no blood transfusion in the past 14 days, platelets >=100x10^9/L; (3)In the past 14 days without blood transfusion or erythropoietin, hemoglobin>9g/dL; (4)Total bilirubin =60 ml/min; (7)Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5xULN; (8)Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; (9)Myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are judged by the investigator to be of no clinical significance are also allowed to be included in the group); 11.For female subjects of childbearing age, a urine or serum pregnancy test and the result should be negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-bearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy; 12.If there is a risk of conception, all subjects (whether male or female) need to adopt a low annual failure rate during the entire treatment period until 1
Exclusion criteria
Exclusion criteria: 1.Have previously received any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs for SCLC or for another stimulus or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) Drugs, etc.; 2.Diagnosis of other malignant diseases other than SCLC within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically excised carcinoma in situ); 3.Are currently participating in interventional clinical research treatment, or have received other research drugs or used research devices within 4 weeks before the first administration; 4.An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 5.Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: The use of physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent drugs) is allowed; 6.There is clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not need to drain the effusion or stop drainage for 3 days without a significant increase in effusion can be included in the group); 7.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8.Patients are known to be allergic to active ingredients or excipients such as Sintilimab, Anlotinib, Albumin Paclitaxel, etc.; 9.Before starting treatment, have not fully recovered from toxicity and/or complications caused by any intervention (i.e., <= Grade 1 or reached baseline, excluding fatigue or hair loss); 10.Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive); 11.Untreated active hepatitis B (defined as HBsAg positive and the number of HBV-DNA copies detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center); Note: Hepatitis B subjects who meet the following criteria can also be included in the group: (1)Before the first administration, the HBV viral load is less than 1000 copies/ml (200 IU/ml), and the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation; (2)For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), there is no need to receive preventive anti-HBV treatment, but close monitoring of virus reactivation is required; 12.Active HCV infected subjects (HCV antibody-positive and HCV-RNA level is higher than the lower limit of detection); 13.Live vaccines have been vaccinated within 30 days before the first administration (cycle 1, day 1); Note: It is allowed to receive inactivated virus vaccine for seasonal influenza injection within 30 days before the first administration; However, it is not allowed to receive live attenuated influenza vaccine for intranasal administration. 14.Pregnant or lactating women; 15.There are any serious or uncontrollable systemic diseases, such as: (1)The resting electrocardiogram has major abnormalities in rhythm, co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, PFS;Disease Control Rate, DCR;Duration of remission, DOR;overall survival, OS;safety; | — |
Countries
China
Contacts
Public ContactWang Zhehai
Shandong Cancer Research Institute
Outcome results
None listed