Lung Cancer
Conditions
Interventions
Experimental group:Sintilimab combined with anlotinib hydrochloride and doublet chemotherapy
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged >= 18 years; 3. Histologically confirmed, unresectable or inoperable or locally advanced (stage IIIB), recurrent or metastatic (stage IV) malignant pleural mesothelioma; 4. According to the modified version of the solid tumor response evaluation criteria (mRECIST version 1.1), at least one lesion can be measured by imaging; 5. Have not received any systemic antitumor therapy for advanced/metastatic disease before. For patients who have received platinum-containing adjuvant/neoadjuvant chemotherapy in the past, or have received radical chemoradiotherapy for advanced disease, such as disease progression or recurrence and the end of the last chemotherapeutic drug treatment, the interval of at least 6 months is allowed to be enrolled in this study; 6. Patients with asymptomatic or stable brain metastases after local treatment are allowed to enroll, as long as the patients meet the following conditions: (1) Measurable lesions outside the central nervous system; (2) No central nervous system symptoms or no exacerbation of symptoms for at least 2 weeks; (3) No need for glucocorticoid therapy or discontinuation of glucocorticoid therapy within 7 days before the first study drug administration; 7. Patients are allowed to receive palliative radiotherapy, but the end of radiotherapy is within 7 days before the first study drug administration; 8. ECOG score 0-1 points; 9. Expected survival time > 3 months; 10. Sufficient organ function, patients should meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) is >=1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelets >=100x10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin>9g/dL without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin 1.5 x ULN but direct bilirubin =60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, patients with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that simple laboratory abnormalities that are not clinically significant are also allowed to be included in the group); (optional) 11. For female patients of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 12. If there is a risk of pregnancy, all patients (no gender limit) are required to use contraceptive measures with an annual failure
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than malignant pleural mesothelioma within 5 years before the first administration (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and/or radically resected carcinoma in situ) ; 2. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 3. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 drug, or another drug that stimulates or synergistically inhibits T-cell receptors (eg, CTLA-4, OX-40, CD137 ); 4. Received systemic systemic treatment of Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration; 5. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 6. Those who are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids ( 325 mg/day) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function for 10 consecutive days; 18. Current or recent (within 10 days before receiving the first dose of study drug) for 10 consecutive days with full-dose oral or parenteral anticoagulants or thrombolytics; Note: Prophylactic use of low-dose anticoagulants is permitted: on the premise that the international normalize
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Duration of relief;Overall survival; | — |
Countries
China
Contacts
Public ContactDuan Jianchun
Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed