Ovarian clear cell carcinoma
Conditions
Interventions
Combined treatment group:Surufatinib 250mg,QD,orally combined with toripalimab 240mg, D1, once every 3 weeks (Q3W) intravenously.
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-75; 2) Understand the research procedure and content, and voluntarily sign a written informed consent; 3) Histologically confirmed clear cell carcinoma of the ovary, including simple or mixed clear cell carcinoma. In mixed clear cell carcinoma, the clear cell carcinoma component must be greater than 50%; 4) Disease recurrence or progression after receiving 1 or 2 lines of standard platinum-containing chemotherapy (if only first-line chemotherapy is received, platinum-free interval < 12 months or tumor progression during chemotherapy) 5) According to RECIST 1.1, the patient must have at least one measurable target lesion (maximum diameter =10mm, or minimum diameter =15mm lymph node) examined by CT or MRI. 6) Expected survival =3 months; 7) ECOG PS score 0-2 points; 8) The patient should provide sufficient formalin fixed paraffin embedded (FFPE) specimens or sections prepared from tumor archived tissue or fresh tissue that meet the testing criteria, and be willing to undergo tumor tissue biopsy if necessary for the detection of ARID1A gene, PD-L1, dMMR and/or MSI, TMB. 9) The values of laboratory tests performed by screening must meet the following criteria: a) Blood routine examination (no blood transfusion, no G-CSF, no drug correction within 14 days prior to the test): i. Hemoglobin (HGB)=90g/L; ii. Absolute neutrophil count (ANC)=1.5×10^9/L; iii. Platelet (PLT)=100×10^9/L; b) Biochemical examination: i. Total bilirubin (TBIL)=1.5× upper limit of normal (ULN)(Gilbert syndrome =5×ULN); ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)=2.5×ULN(ALT and AST=5×ULN if liver metastasis exists); iii. Serum creatinine (Cr)=1.5×ULN or endogenous creatinine clearance =50mL/min(Cockcroft-Gault formula) iv. International standardized ratio (INR) = 1.5x ULN and partially activated prothrombin time (APTT) = 1.5x ULN; c) Thyroid function indicators: thyroid stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range; If TSH is not in the normal range, FT3/FT4 can be added in the normal range. d) Urine routine examination showed urinary protein <2 combination; If urinary protein =2 combined, 24-hour urinary protein quantity should be <1g; 10) Study non-pregnant women identified within 7 days prior to medication; Women of reproductive age must agree to use medically recognized effective contraception throughout the study period and for 6 months after the end of the study; 11) Patients can follow up on schedule, communicate well with the investigators and complete the study according to the provisions of the study.
Exclusion criteria
Exclusion criteria: 1) Toxicity associated with previous antitumor therapy did not return to =CTCAE grade 1, except hair loss and oxaliplatin induced =CTCAE grade 2 peripheral neurotoxicity; 2) Other malignancies in the past 5 years (except basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, which have been effectively controlled); 3) Symptomatic central nervous system (CNS) metastasis or cancerous meningitis (meningeal metastasis) were present during the screening period; 4) Received approved systemic antitumor therapy within 4 weeks prior to initial medication, including: Chemotherapy (oral washout period of fluorouracil drugs is 2 weeks), biological therapy, targeted therapy (small molecule targeted drugs have a washout period of 2 weeks or 5 half-lives, depending on the length), hormone therapy, Chinese medicine therapy (Chinese medicine with clear anti-tumor indications in the instructions, 1 week of washout period before the first drug use), etc.; 5) Received radical radiotherapy (including more than 25% bone marrow radiotherapy) within 4 weeks before the first dose; Brachytherapy (e.g. implantation of radioactive particles) within 60 days before the first dose; He had received palliative radiotherapy for bone metastases within 1 week before first administration 6) Patients who were previously treated with anti-VEGF/VEGFR-targeted drugs and had disease progression during medication or within 4 months after the last dose 7) Previously received antibodies against programmed death-1 (PD-1) or its ligand (PD-L1), cytotoxic T-lymphocyte-associated protein 4, CTLA-4) antibodies or other drugs that act on T-cell co-stimulation or checkpoint pathways 8) Thyroid dysfunction that is symptomatic or requires treatment at the time of screening (hypothyroidism that can only be controlled with thyroid hormone replacement therapy can be included); TSH levels > 0.1mU /L (or corresponding other unit levels) in patients with iodine-resistant differentiated thyroid cancer before initiation of study therapy 9) Have any active autoimmune disease requiring systemic treatment or have a history of autoimmune disease within the past 2 years, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitaritis, vasculitis, systemic lupus erythematosus, etc. (vitiligo, psoriasis, alopecia, or Grave's disease without systemic treatment within the last 2 years, Patients with type 1 diabetes requiring only insulin replacement therapy may be included); Known history of primary immunodeficiency; Only patients with positive autoimmune antibodies should be confirmed for autoimmune disease at the discretion of the investigator 10) Received systemic immune stimulants within 4 weeks prior to the first dose 11) Receive any live or attenuated vaccine within 4 weeks before the first dose or during the study period; 12) Major surgical operations (defined as Grade 3 and Grade 4 operations according to the Administrative Measures for Clinical Application of Medical Technology implemented on May 1, 2009) or unhealed wounds, ulcers, or fractures within 4 weeks prior to the first medication 13) Uncontrolled malignant pleural effusion, ascites, or pericardial effusion (defined as not effectively controlled by diuretics or puncture as determined by the investigator); 14) The patient currently has high blood pressure that is not controlled by medication, which is defined as: systolic blood pressure =140mmHg and/or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression survival time, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Overall survival, OS ;Adverse events, AE; | — |
Countries
China
Contacts
Public ContactHuijuan Yang
Fudan University Shanghai Cancer Center
Outcome results
None listed