Advanced Thymic carcinoma
Conditions
Interventions
Experimental group:Triplizumab in combination with Anlotinib
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have a thorough understanding of this study and voluntarily sign the informed consent form; 2. Age must be 18 years old or above, or 75 years old or below, with no gender restrictions. 3. Pathological examination confirmed thymus carcinoma; 4. Patients who failed first-line standard treatment or relapsed within six months of postoperative chemoradiotherapy, and had not received immune checkpoint inhibitor therapy before; 5. ECOG 0-1 point; 6. The patient must have at least one measurable lesion (RECIST 1.1); 7. Other major organs (liver and kidney function, electrolytes, blood indicators, etc.) function well: (1) Absolute neutrophil count (ANC)>=1.5×10^9/L, platelet >=100×10^9/L, hemoglobin >=90 g/L. Note: Patients were not allowed to receive blood transfusion or growth factor support for <=14 days before blood sampling during screening. International normalized ratio (INR) or prothrombin time (PT)<=1.5× upper limit of normal value (ULN); (3) Activated partial thromboplastin time (APTT)<=1.5×ULN; (4) Total serum bilirubin <=1.5×ULN(Gilbert's syndrome patients must have total bilirubin <3×ULN); (5) aspartate and alanine aminotransferase (AST and ALT)<=2.5×ULN, or liver metastasis <=5×ULN; 8. Women of childbearing age must undergo a pregnancy test within 7 days before starting treatment and the result is negative; Reliable contraceptive methods (such as Iuds, contraceptives and condoms) should be used within 30 days of the start and end of the trial; Male participants of reproductive age should use condoms during the trial period and for 30 days after the trial ends.
Exclusion criteria
Exclusion criteria: 1. Non-thymic carcinoma was confirmed by pathological diagnosis; 2. Received immunosuppressive drugs within 4 weeks prior to admission, excluding nasal, inhaled, or other local corticosteroids or systemic corticosteroids at physiological doses (i.e., no more than 10mg/ day of prednisone or equivalent doses of other corticosteroids), or used to prevent hypersensitivity to contrast media; 3. The patient has an active autoimmune disease or a history of autoimmune disease that may recur; 4. Active hepatitis B and C patients need to receive relevant antiviral therapy, HBV-DNA < 2000 IU/ml (< 104 copies /ml), and have received anti-HBV therapy for at least 14 days before entering the study, and continue treatment during treatment; HCV RNA positive patients must receive antiviral therapy and have liver function within CTCAE grade 1 elevation. 5. Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or women of childbearing age who were unwilling to use effective contraception throughout the trial period and within 6 months after the last study; 6. Patients with a history of monoclonal antibody drug allergy; 7. Patients who have previously received allogeneic stem cells or parenchymal organ transplants; 8.Having mental illness or any other disease that causes treatment. 9. Patients who are unable or unwilling to sign informed consent; 10. The investigator believes that the subject's comorbidities or other conditions may affect adherence to the protocol or may not be suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactZhao Lei
Sun Yat-sen University Cancer Center
Outcome results
None listed