Thymic Carcinoma
Conditions
Interventions
3.0 mg/kg group:Once every three weeks (Q3W)
Sponsors
West China Hospital of Sichuan University, Shandong Provincial Institute of Cancer Prevention and Treatment (Shandong Cancer Hospital), Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Compliance of the protocol and visit plan, voluntary participation in the study and signing of the informed consent in writing; 2. Aged >=18 years on the date of signing informed consent, both genders; 3. ECOG performance status scores 0-2; 4. Expected survival >=12 weeks; 5. Thymic carcinoma diagnosed histologically (WHO classification, 2015); 6. Patients with recurrent or metastatic thymic carcinoma that is unresectable or unsuitable for radical radiotherapy based on Masaoka staging; 7. Failure of at least first-line or above systemic chemotherapy defined as the progression or intolerable toxic reaction during first-line systemic chemotherapy or after therapy. Evidence of imaging should be provided for disease progression. For neoadjuvant therapy/ adjuvant therapy (chemotherapy or chemoradiotherapy), failure of the first-line therapy should be reported if progression of disease occurs during the therapy or within six months after discontinuation of therapy; 8. There is at least one measurable lesion based on RECIST V1.1. The measurable lesion located at prior radiotherapy radiation field or those proved to be progressive after local treatment can be selected as targeted lesion; 9. Systemic chemotherapy, radical/extensive radiotherapy, targeted therapy ended at least 28 days prior to the first dose; 10. Local palliative radiotherapy ended at least 14 days prior to the first dose; 11. AEs related to systemic chemotherapy, radical/extensive radiotherapy that have reduced to =1.5x10^9/L; platelet count (PLT) >=80x10^9/L; hemoglobin content (HGB) >=9.0g/dL; Note: Repeated screening is allowed during the window period of 14 days prior to examination as long as the criteria of laboratory examination are met; transfusion of any blood components, cell growth factors, or other interventions (excluding oral drugs) aiming at making the indicators acceptable are prohibited within 14 days prior to the examination. Liver function: Serum total bilirubin (TBIL) =50 ml/min (as per Cockcroft-Gault formula); Adequate coagulation function, which is defined as the international normalized ratio (INR) =40 kg; 14. Fertile male and female in the child-bearing period who are willing to take effective contraception measures during the period from signing of informed consent to 6 months after last dose of investigational drug; female in child-bearing period includes premenopausal women and those women who are less than 2 years post-menopause. Pregnancy test of blood <=7 days prior to the first dose of investigation drug for female in the child-bearing period must be negative.
Exclusion criteria
Exclusion criteria: 1. Mixed thymic carcinoma (Pathological results show that the tumor contains at least one component of thymic carcinoma, as well as any other types of thymic epithelial tumors, including thymoma and thymic carcinoma; tumor containing components of small cell or large cell neuroendocrine cancer; 2. Other malignant tumors during the past 5 years (well-controlled basal cell carcinoma and cervical carcinoma in situ excluded); 3. Currently participating in interventional clinical study, or received other investigational drug or used investigational device within 4 weeks prior to the first dose; 4. Presenting with any toxic reaction resulting from past anti-tumor therapy that >grade 1 (alopecia and clinically insignificant and asymptomatic laboratory abnormalities excluded) based on NCI CTCAE V5.0; 5. Past administration of anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 drugs, or any other drugs targeting T cell costimulation or checkpoint pathway (e.g., OX40 and CD137); 6. Dosing of immunosuppressive drug within four weeks prior to the first dose of investigational drug, except for the following: (1) Nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (i.e., prednisone (<10 mg/day) or equivalent other glucocorticoids); (2) Glucocorticoids, as prophylaxis for anaphylaxis (for example, to prevent radiocontrast mediacontrast anaphylaxis); 7. Having underwent a major surgical operation within 4 weeks prior to the first dose of investigational drug, or expected to undergo major surgery during the study; 8. Live vaccine or attenuated live vaccine was given or will be given within 4 weeks prior to the first dose of investigational drug or during the study or within 5 months at last dose; 9. Being allergic to recombinant humanized PD-1 monoclonal antibody or any excipients used; having allergic disease history or severe allergic constitution; 10. Systemic therapy including administration of anti-tumor indications Chinese herbal medicine, Chinese patent medicine or immunomodulatory drugs, including thymosin, interferon, interleukin (local application for pleural effusion or pericardial effusion excluded) within 2 weeks prior to the first dose of investigational drug; 11. History of active, known autoimmune disease, including but not limited to myasthenia gravis, pure red blood cell aplastic anemia, hypogammaglobulinemia, systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis; following are excluded: Type I diabetes, hypothyroidism that can be controlled by hormone replacement therapy, skin diseases not requiring systemic treatment (e.g., vitiligo), and controlled celiac disease; 12. Subjects with central nervous system metastases can be included if the following are met: if they received brain metastasis therapy previously, the subjects condition is stable, i.e., there is no evidence of imaging suggestive of disease progression at least four weeks prior to the first dose of investigational drug, and each neurological symptom reduce to the base level; there is no evidence showing recent brain metastasis or enlargement of existing brain metastasis lesion, and there is no need for steroid therapy at least 14 days prior to the first dose of investigational drug. Patients with carcinomatous meningitis are excluded regardless of the clinical condition; 13.Severe chronic or active infections that require systemic antibact
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR), Overall Survival (OS), Progression-free Survival (PFS), Disease Control Rate (DCR), Time to Response (TTR), Percentage of patients with stable disease for more than 3 months, Percentage of patients with stable disease for more than 6 months; | — |
Countries
China
Contacts
Public ContactXu Zhonghu
Livzon Mabpharm Inc.
Outcome results
None listed