soft tissue sarcoma
Conditions
Interventions
soft tissue sarcoma:? Cadonilimab was administered by intravenous infusion at a dose of 6mg/kg every 2 weeks.
? Surufatinib capsules: 200mg (4 capsules) each time, can be taken with a low-fat meal or
Sponsors
Shanghai Tongren Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 12~75 years old (inclusive), gender is not limited; 2) Patients with histopathologically diagnosed advanced soft tissue sarcoma who have previously used at least one anthracycline-based chemotherapy regimen and whose disease has progressed or been intolerated within the last 6 months (except for acinous soft tissue sarcoma and clear cell sarcoma); 3) ECOG score 0-2; 4) Expected survival =3 months; 5) According to RECIST 1.1, there is at least one measurable lesion, and those having received local treatment such as radiotherapy cannot be regarded as measurable lesions; 6) Having adequate organ and bone marrow function, as defined below: a) Blood routine: neutrophil count (NEUT#) =1.5×109/L; Platelet count (PLT) =90×109/L; Hemoglobin concentration =9 g/L; b) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3× upper limit of normal (ULN); Total bilirubin (TBIL) =1.5×ULN; For subjects with liver metastasis, ALT and AST=5×ULN; For subjects with liver metastasis or Gilbert syndrome, TBIL=2×ULN; c) Renal function: serum creatinine =1.5×ULN or creatinine clearance (CCR) =50 mL/min (Cockcroft-Gault formula); d) Coagulation function: International normalized ratio (INR) =1.5×ULN and activated partial thromboplastin time (APTT) =1.5×ULN; e) Thyroid stimulating hormone (TSH), free thyroxine (FT4) and free triiodothyronine (FT3) were all within the normal range of ±10%. Subjects with drug-controlled hypothyroidism could be enrolled, while those with hyperthyroidism could not be enrolled; 7) During the study period and for 6 months after the end of dosing, childbearing age subjects (both male and female) must use effective medical contraception. For female subjects of childbearing age, a pregnancy test should be performed within 72 hours before the first dose, and the result is negative; 8) The subjects voluntarily joined this study, signed the informed consent, and complied with the visit and related procedures stipulated in the program.
Exclusion criteria
Exclusion criteria: 1) Have multiple factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction); 2) Prior treatment with cadonilimab or surufatinib, but prior treatment with one other type of immune checkpoint inhibitor (including PD-1, PD-L1, or CTLA-4 monoclonal antibody) or one other anti-angiogenesis targeted agent is permitted; 3) The presence of any active autoimmune disease or history of autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, rheumatoid arthritis, nephritis, pituitaritis, etc.); Subjects with vitiligo or asthma in childhood still require medical intervention as adults; Subjects requiring medical intervention with bronchodilators for asthma. 4) History of severe allergic disease, history of severe drug allergy, known allergy to macromolecular protein preparations; 5) Use of any active vaccine against infectious diseases (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before the first dose or during the study period; 6) Subjects with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 7) History of other malignant tumors (except cured non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer, breast cancer, localized prostate cancer, etc., which researchers considered to be eligible for inclusion); 8) Have received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or have had autologous hematopoietic stem cell transplantation within 3 months before the first administration of the drug; 9) Have an active infection, or an unexplained fever before the first dose; 10) Systemic use of antibiotics within 1 week before signing the informed consent; 11) Systemic treatment with steroid hormones (dose equivalent to prednisone >10 mg/ day) or other immunosuppressants within 14 days prior to initial administration; Note: In subjects without active immune disease, epinephrine replacement therapy at a dose equivalent to prednisone =10 mg/ day is permitted. Use of topical, intraocular, intraarticular, intranasal, or inhaled corticosteroids is permitted (systemic absorption is very low); Short-term use of corticosteroids is permitted for prevention (such as allergy to contrast agents) or treatment of non-autoimmune conditions (such as delayed hypersensitivity caused by exposure to allergens). 12) Patients with serious medical conditions, such as grade III and above cardiac dysfunction (NYHA criteria), ischemic heart disease (such as myocardial infarction or angina pectoris) and other cardiovascular diseases, poorly controlled diabetes (fasting blood glucose =10 mmol/L), Poorly controlled hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg) with an ejection fraction <50% on echocardiography; 13) Hereditary bleeding tendency or coagulation dysfunction. Have clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, or vasculitis; Deep vein thrombosis or pulmonary embolism within 6 months prior to first dosing; 14) Known acute or chronic active hepatitis (Hepatitis B: chronic HBV carriers or inactive HBsAg positive subjects can be enrolled if HBV DNA<1×103IU/mL; Hepatitis C: HCV ant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR;Disease control rate, DCR;Duration of remission, DOR;Overall survival, OS;security;adverse event rate; | — |
Countries
China
Contacts
Public ContactJianjun Zhang
Shanghai Tongren Hospital
Outcome results
None listed