Pleural Mesothelioma
Conditions
Interventions
Case series:camrelizumab combined with pemetrexed and platinum
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for this trial: 1. Male or female aged 18-75 years; 2. Histologically confirmed diagnosis of advanced unresectable pleural mesothelioma; 3. No previous systemic anti-tumor treatment for advanced/metastatic disease; (it can be included if the disease progression occurred > 6 months after the last treatment, and adverse events caused by previous (neoadjuvant) adjuvant therapy recovered to =90 g/L; neutrophil count (ANC) >=1.5x10^9/L; platelet count (PLT) >=100x109/L; (2) biochemical examination must meet the following criteria: total bilirubin (TBIL) 60 ml/min (Cockcroft-Gault formula); urine routine test results showed urine protein (UPRO) < 2 + or 24-hour urine protein quantification < 1 g; 8. Fertile women must have used reliable contraception or had a pregnancy test (serum or urine) within 7 days prior to enrollment and had a negative result, and be willing to use an appropriate method of contraception during the trial and for 60 days after administration of the trial drug. Men should agree to use appropriate methods of contraception during the trial period and 120 days after the last administration of the trial drug or have undergone surgical sterilization; 9. Sign the informed consent form, have good compliance to the study protocol.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this trial: 1. Patients with active brain metastases (patients with stable symptoms of brain metastases after treatment can participate in this study as long as they meet all the following criteria: measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord metastases; remain stable for at least 2 weeks); 2. Patients with pulmonary fibrosis or interstitial pneumonia; 3. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit another T cell receptor (e.g., CTLA-4, OX-40, CD137); 4. Use of immunosuppressive drugs within 14 days before the first use of camrelizumab, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/day prednisolone or other corticosteroids at the same physiological doses); 5. Systemic treatment with Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 14 days before the first use of camrelizumab; 6. Palliative radiation therapy within 7 days prior to first dose. Patients who have received palliative radiotherapy 7 days before the first dose must meet all the following conditions: there is no radiation-related toxicity, glucocorticoid is not required, and radiation pneumonitis is excluded; 7. Patients with severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >=450ms in males and >=470ms in females); cardiac insufficiency grade III-IV (according to New York Heart Association NYHA classification), or cardiac ultrasound examination showed that LVEF < 50%; 8. Current participation in an interventional clinical trial, or treatment with another investigational drug or investigational device 4 weeks prior to the first dose; insufficient recovery (i.e., <=1 grade or at baseline, excluding fatigue or alopecia) from toxicities and/or complications caused by any intervention before the first dose; 9. With uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (drainage once a month or more frequently); 10. Pleurodesis within 14 days before enrollment; 11. Surgery with local or topical anesthesia within 14 days prior to enrollment; 12. The subject has received or plans to receive organ or hematologic transplantation (except for corneal transplantation) during the study period; 13. Presence of active autoimmune diseases, immunodeficiency, or history as following, including but not limited to: autoimmune hepatitis, pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc. Exceptions include patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy and patients with type 1 diabetes who are controlled with their insulin regimen are allowed to participate; 14. Not satisfactorily controlled asthma even the subject has received systemic treatment including bronchodilator (subjects can be enrolled if the asthma has been completely relieved in childhood, without any intervention after adulthood); 15. Ssevere infection (such as requiring intravenous antibiotics, antifungal or antiviral drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Objective response rate (ORR);Disease control rate (DCR);Duration of remission (DOR); | — |
Countries
China
Contacts
Public ContactXingsheng Hu
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed