Thymic carcinoma
Conditions
Interventions
Ivonescimab Plus Chemotherapy Group:Ivonescimab Plus Chemotherapy
Sponsors
China Medical University Affiliated Shengjing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria in order to be enrolled in this study: 1. Agree to follow the experimental treatment plan and visit schedule, voluntarily join the group, and sign a written notice; On the day of signing the informed consent form, individuals must be at least 18 years old and have no gender restrictions; 3. ECOG physical fitness status score is 0-1 points; 4. Expected survival period = 12 weeks; 5. Masaoka stage III or IV thymic cancer patients with tissue or cytological evidence; 6. According to the RECIST V1.1 evaluation criteria for solid tumor efficacy, if there is at least one measurable lesion located within the previous radiation field or after local treatment, it can also be selected as a target lesion if progression is confirmed; 7. The subjects have sufficient organ and bone marrow function to meet the following laboratory test criteria: (1) Blood routine: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelet count (PLT) >= 80 × 10^9/L; Hemoglobin content (HGB) >= 9.0g/dL; Note: It is not allowed to intervene with any blood components, cell growth factors, etc. within 14 days before the examination to bring the indicators within the normal range Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) = 50mL/min (Cockcroft Gault equation); (3) Renal function: Blood creatinine (Scr) = 50mL/min (Cockcroft Gault equation); (4) Adequate coagulation function, defined as an International Normalized Ratio (INR) <= 1.5 or Prothrombin Time (PT) <= 1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the PT or INR is within the range specified by the anticoagulant drug, it is sufficient; 8. Men with fertility and women of childbearing age are willing to take effective contraceptive measures from the signing of the informed consent form until 6 months after the last administration of the experimental drug; Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test result within <= 7 days before the first trial drug administration.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following exclusion criteria will not be included in this study: 1. Mixed thymic carcinoma (pathological results show that the tumor contains at least one component of thymic carcinoma, accompanied by any other type of thymic epithelial tumor [including thymoma and thymic carcinoma]), tumors containing small or large cell neuroendocrine carcinoma components; 2. Suffering from other malignant tumors within the past 5 years (excluding skin basal cell carcinoma and cervical carcinoma in situ that have been effectively controlled); 3. Known active central nervous system (CNS) metastases/cancerous meningitis. Subjects who have previously received brain metastasis treatment are eligible to participate, as long as they are stable (with no evidence of imaging progression for at least 4 weeks prior to the first dose of trial treatment, and any neurological symptoms have recovered to baseline levels), have no new or expanded evidence of brain metastasis, and have not used steroids for at least 7 days prior to trial treatment 4. Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 5. Prior to the initial administration of the investigational drug, there were toxicity levels 1 (excluding hair loss, non clinically significant, and asymptomatic laboratory abnormalities) caused by previous anti-tumor treatments that did not recover to the National Cancer Institute Common Adverse Event Terminology 5.0 (NCI CTCAE V5.0); Has had active autoimmune disease in the past 3 months, requiring systemic treatment, or has a documented history of severe autoimmune disease, or a syndrome requiring systemic steroids or immunosuppressants. Subjects with vitiligo or childhood asthma/atherosclerosis, subjects requiring intermittent use of bronchodilators or local steroid injection, and subjects with hypothyroidism and stable hormone replacement or Sjorgen syndrome are excluded; 6. Previous use of anti-PD-1, anti-PD-L1, anti programmed death receptor ligand 2 (PD-L2), or anti cytotoxic T lymphocyte associated antigen 4 (CTLA-4) drugs or any other drugs that act on T cell co stimulatory or checkpoint pathways (such as OX40, CD137, etc.); 7. Use of immunosuppressive drugs within 4 weeks prior to the first administration of the investigational drug, excluding: (1) Local corticosteroids administered via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses (i.e.<10mg/day prednisone or its equivalent dose of other corticosteroids); (2) Corticosteroids as a preventive medication for allergic reactions (such as preventing contrast agent allergies); 8. Have undergone major surgical procedures within 4 weeks prior to the first treatment with the investigational drug or are expected to undergo major surgery during the study treatment period; 9. Expected to receive live or attenuated vaccines within 4 weeks prior to the first administration of the investigational drug, during the study period, or within 5 months of the last administration; 10. Known to be allergic to recombinant humanized PD-1 monoclonal antibody or any of its excipients; Known history of allergic diseases or severe allergic constitution; 11. Within 2 weeks before the first administration of the investigational drug, he has received systematic systemic treatment with Chinese herbal medicine, traditio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS);duration of remission (DoR);overall survival (OS); | — |
Countries
China
Contacts
Public ContactHan Chengbo
Shengjing Hospital of China Mdical University
Outcome results
None listed