untreated advanced thymic cancer
Conditions
Interventions
Combination therapy of Tislelizumab and albumin paclitaxel/carboplatin:Tislelizumab combined with albumin paclitaxel/carboplatin
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.a) The subjects follow the principle of voluntary participation and sign an informed consent form; 2.b) Has not received systematic anti-tumor treatment in the past; 3.c) Masaoka stage III-IV thymic cancer confirmed by histology/pathology, non-surgical, recurrent or metastatic; 4.d) Age 18 and above, age 80 and below, gender unlimited; 5.e) ECOG score 0-2; 6.f) The bone marrow has good hematopoietic function, with white blood cells>4 × 109/L and neutrophils>1.5 × 109/L; Hemoglobin>10g/dL; Platelets>100 × 109/L; 7.g) Cardiac function is good, with a left ventricular ejection fraction>40%; 8.h) Good renal function, glomerular filtration rate>60 mL/min; 9.i) Good liver function, total bilirubin<1.5 x upper limit of normal value; Aspartate aminotransferase (AST)<3 x upper limit of normal value; Alanine aminotransferase (ALT)<3 x upper limit of normal value; For subjects with combined liver metastasis, total bilirubin<5 x upper limit of normal value; Aspartate aminotransferase (AST)<5 x upper limit of normal value; Alanine aminotransferase (ALT)<5 x upper limit of normal value; 10.j) The subject has measurable lesions defined according to the RECIST 1.1 standard; 11.k) Within 3 days prior to enrollment, women of childbearing age must confirm a negative serum pregnancy test and agree to use effective contraceptive measures during the study drug use period and within 120 days after the last dose. Women of childbearing age are defined as sexually mature women: 1) who have not undergone hysterectomy or bilateral oophorectomy, 2) who have not experienced continuous natural amenorrhea for 12 months (amenorrhea after cancer treatment does not exclude fertility) (i.e., who have experienced menstruation at any time within the previous 12 months).
Exclusion criteria
Exclusion criteria: 1.a) Other malignant tumors were diagnosed within 5 years, except cured skin basal cell carcinoma, superficial bladder cancer cancer, cervical carcinoma in situ, breast ductal carcinoma in situ (DCIS), thyroid papillary carcinoma; 2.b) Subjects who have received systemic anti-tumor treatments such as immunotherapy, targeted therapy, and chemotherapy within 5 years (for those who experience postoperative recurrence, those who have previously received neoadjuvant/adjuvant chemotherapy or adjuvant/curative radiotherapy and chemotherapy and have been at least 6 months since the end of their last treatment can be enrolled); 3.c) A history of active or potentially recurrent autoimmune diseases; 4.d) Patients with active hepatitis B and hepatitis C need to receive relevant antiviral treatment, requiring HBV DNA<500 IU/ml, and have received anti HBV treatment for at least 14 days before participating in the study, and continue to receive treatment during the treatment period; HCV RNA positivity is not eligible for enrollment; 5.e) Allergies to chemotherapy drugs such as carboplatin, albumin bound paclitaxel, etc; 6.f) Has a history of monoclonal antibody drug allergy; 7.g) Previously received allogeneic stem cell or parenchymal organ transplantation; 8.h) Suffering from mental illness or any other illness that makes treatment difficult to comply with; 9.i) Unable to sign or unwilling to sign the informed consent form; 10.j) The researchers believe that the comorbidities or other conditions of the subjects may affect their compliance with the protocol or make them unsuitable to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety; | — |
Countries
China
Contacts
Public ContactLi Xiao
Peking University People's Hospital
Outcome results
None listed