💬In plain words
What the trial is, and whether it could suit you
This study is a single-arm, open-lable, single-center phase II clinical trial for patients with advanced or metastatic pleural mesothelioma. The aim of this study was to observe and evaluate the efficacy and safety of Sintilimab combined with Anlotinib hydrochloride and platinum-containing dual-agent chemotherapy as first-line therapy in malignant pleural mesothelioma.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Sign written informed consent before implementing any trial-related procedures;
* Age ≥ 18 years old.
* Histologically confirmed, unresectable or inoperable or locally advanced (IIIB stage), recurrent or metastatic (IV stage) malignant pleural mesothelioma.
* According to the modified version of the evaluation criteria for the efficacy of solid tumor (mRECIST1.1 ), patients have at least one imaging lesion can be measured;
* Patients have not received any systemic anti-tumor therapy for advanced/metastatic diseases in the past. Patients who have previously received platinum-containing adjuvant / neoadjuvant chemotherapy, or radical radiotherapy and chemotherapy for advanced diseases, such as the interval between disease progression or recurrence and the end of the last chemotherapeutic drug treatment at least 6 months, are allowed to be enrolled in this study.
* Patients with brain metastasis who are asymptomatic or stable after local treatment are allowed to be included in this study, as long as they meet the following conditions:
1. There are measurable lesions outside the central nervous system.
2. No central nervous system symptoms or no aggravation within at least 2 weeks.
3. Those who do not need glucocorticoid therapy or stop glucocorticoid therapy within 7 days before the first study drug administration.
* Patients are allowed to receive palliative radiotherapy, but the end of radiotherapy is within 7 days before the administration of the first study drug.
* ECOG score 0-1 points;
* The expected survival time was \> 3 months,
* For adequate organ function, the patients need to meet the following laboratory indexes:
1. the absolute value of neutrophils (ANC) ≥ 1.5x109/L without granulocyte colony stimulating factor in the past 14 days.
2. in the last 14 days without blood transfusion, the platelet count was ≥ 100x109/L.
3. in the absence of blood transfusion or the use of erythropoietin in the past 14 days, hemoglobin \> 9g/dL;
4. Total bilirubin ≤ 1.5 × normal upper limit (ULN); for example,if total bilirubin \> 1.5 × ULN but direct bilirubin ≤ ULN is also allowed to enter the group
5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (patients with liver metastasis allow ALT or AST ≤ 5 × ULN).
6. Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60ml;
7. Coagulation function is good, defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
8. Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects 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 researchers comprehensively judge that there is no clinical significance of simple laboratory abnormalities can also be included in the group); (optional)
* For female patients at childbearing age, they should undergo a urine or serum pregnancy test within 3 days before receiving the first study drug administration (day 1 of cycle 1) and the results be negative. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Women of non-childbearing age are defined as at least 1 year after menopause or have undergone surgical sterilization or hysterectomy.
* If there is a risk of pregnancy, all patient (male or female) are required to use contraception with an annual failure rate of less than 1% during the entire treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion Criteria:
* Diagnosis of malignant diseases other than malignant pleural mesothelioma (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and / or radical resection of carcinoma in situ) within 5 years before the first administration
* Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
* Previous usage of the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug;
* Within 2 weeks before the first administration, they received systemic systemic therapy with anti-tumor indications of proprietary Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for controlling local use of pleural effusion)
* Active autoimmune diseases requiring systemic treatment (such as the use of disease-relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.
* The patients are received systemic glucocorticoid therapy (excluding nasal, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration.
Note: The use of physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent drugs) is allowed;
* There are clinically uncontrollable pleural effusion / ascites (patients who do not need drainage or stop drainage for 3 days without a significant increase in effusion can be enrolled in the group)
* Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
* Those who are known to be allergic to the active ingredients or excipients of Sintilimab in this study.
* Patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
* Symptomatic or uncontrolled br