malignant mesothelioma
Conditions
Interventions
Sponsors
Jilin Provice Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures; 2. Male or female, aged >= 18 years; 3. Malignant mesothelioma confirmed by histology, without indication for surgery; 4. Have not received systemic anti-tumor therapy in the past (if the subject has received neoadjuvant or adjuvant chemotherapy in the past, the last treatment time must be more than 6 months from the time of recurrence); 5. Sufficient organ function; 6. Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0-1; 7. Expected survival period >= 12 weeks; 8. There is at least one measurable lesion (malignant pleural mesothelioma is based on mRECIST version 1.1, and malignant mesothelioma in other parts is based on RECIST version 1.1); 9. All subjects should undergo fresh tumor lesion biopsy during the screening period (bone biopsy, fine-needle biopsy, and pleural and ascites samples are not accepted; biopsy is not accepted for subjects with only the only target lesion available for biopsy), obtain enough qualified tumor tissue samples for biomarker (including PD-L1 expression) analysis; If a biopsy is not available, the subject should provide a formalin-fixed-paraffin-embedded (FFPE)-processed tumor sample (unstained section, 3-5 µm) recently (up to 24 months) from the start of study treatment ) for the corresponding biomarker analysis; If the subject is unable to provide a specimen that meets the above requirements due to special reasons, it will be decided whether the subject can participate in the screening after communicating with the sponsor's medical manager; 10. Fertile female subjects have negative blood pregnancy results within 7 days before starting the study treatment, and are willing to maintain abstinence or take medically recognized high-efficiency drugs from the signing of the informed consent form to 6 months after the end of the last medication. Contraceptive measures (such as IUDs, condoms); 11. Male subjects are willing to abstain from sex or take medically approved high-efficiency contraceptive measures from the signing of the informed consent form to 6 months after the end of the last medication, and do not donate sperm during this period.
Exclusion criteria
Exclusion criteria: 1. History of severe allergic diseases, severe drug (including unmarketed test drug) allergy history, or known allergy to any component of the drug in this study; 2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, judged by the investigators as not suitable for inclusion; 3. Evidence of major coagulation disorders or other significant bleeding risks: (1) History of intracranial hemorrhage or intraspinal hemorrhage; (2) Tumor lesions invading large blood vessels with obvious risk of bleeding; (3) Within 6 months before starting the study treatment, thrombosis or embolism events occurred (except asymptomatic intermuscular venous thrombosis that does not require treatment), or significant vascular disease (such as aortic aneurysm requiring surgical repair); (4) Clinically significant hemoptysis or tumor bleeding for any reason within 6 months before the start of study treatment; (5) Within 2 weeks before starting the study treatment, use anticoagulant therapy for therapeutic purposes (except low molecular weight heparin); (6) Antiplatelet drugs such as aspirin (> 325 mg/day), clopidogrel (> 75 mg/day), dipyridamole, ticlopidine or cilostazol were used within 10 days before the start of study treatment , or those who need long-term antiplatelet therapy; 4. Received the following treatments or drugs before starting the study drug treatment: (1) Received major organ surgery (excluding biopsy) or experienced significant trauma or dental invasive operations (such as dental implants) within 4 weeks before starting study drug treatment, or required elective surgery during the trial period; (2) Received palliative radiotherapy within 14 days before starting study drug treatment; (3) Received immunotherapy, nitrosourea, mitomycin C within 6 weeks before starting study drug treatment; (4) Received systemic immunostimulant therapy (such as thymosin, interferon-a [IFN-a], interleukin-2 [IL-2]) within 14 days before starting the study drug treatment or still within 5 half-lives of the treatment drug (take the longer of the two); (5) Received systemic glucocorticoids (prednisone > 10 mg/day or equivalent doses of similar drugs) or other immunosuppressant therapy within 14 days before starting the study drug treatment; except for the following situations: pemetrexed medication Pretreatment; treatment with topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticoids; short-term prophylaxis with glucocorticoids (eg, to prevent allergy to contrast media); (6) Received live attenuated vaccine within 4 weeks before starting study drug treatment; (7) Received intravenous broad-spectrum antibiotic therapy within 14 days before starting the study treatment; 5. Subjects who have active or have suffered from autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except clinically stable autoimmune thyroid disease Type I diabetic subjects; 6. Had other active malignant tumors within 5 years before starting the study drug treatment, except for malignant tumors that can be treated locally and cured (such as skin basal cell or squamous cell carcinoma, superficial or non-invasive bladder cancer), cervical carcinoma in situ, breast ductal carcinoma in situ, papillary thyroid carcinoma); 7. Within 6 months before starting the study drug treatment, the following situations occurred: (1) Acute coronary syndrome, coronary artery bypass grafting, cong
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Incidence and severity of treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactYing Cheng
Pumis Biotechnology (Zhuhai) Co., Ltd.
Outcome results
None listed