Adenoid soft tissue sarcoma
Conditions
Interventions
Single-arm Group:Aparolitovorelizumab (QL1706) 5 mg/kg intravenous infusion every 3 weeks
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Enrollment Criteria All of the following inclusion criteria must be met to be enrolled in this study: (1) Age>=18 years old, regardless of gender; (2) Eastern American Cooperative Oncology Group Physical Status Score (ECOG PS) of 0 or 1 point; (3) Expected survival time>=3 months. (4) Patients with pathologically confirmed advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV) (staged according to the 8th edition American Joint Committee on Cancer [AJCC]); (5) Previous systemic targeted therapy is acceptable, if previously received sunitinib, pazopanib, Tyrosine kinase inhibitor therapy such as anlotinib requires at least 2 months of washout before the first dose; (6) At least one measurable lesion according to RECIST v1.1 criteria. Computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline to show that the long diameter is >=10 mm (except for lymph nodes, the short diameter of lymph nodes must be >=15 mm), and the lesion is suitable for repeated accurate measurement; If it is a lesion located in a previously irradiated area, it is clearly demonstrated if there is progression, the lesion can be used as a target lesion; (7) Organ function is good and the following criteria must be met: 1) Bone marrow function must be measured within 14 days prior to enrollment, and white blood cell count (WBC) >=3.5×10^9 /L, hemoglobin (Hb) >=90 g/L, absolute neutrophil count (ANC) >=1.5×10^9 /L, platelets (PLT) >=80×10^9 /L, and no blood transfusion or biological response modulators (such as granulocytes, erythrocyte growth factor, blood cell growth factor, etc.) within 14 days before the screening period. 2) Liver function: Liver function must be tested within 14 days before enrollment, and serum is required for patients without liver metastases Total bilirubin (TBIL) =60 mL/min (based on the Cockcroft-Gault formula). 4) Urine protein =2 by urine dipstick test at baseline should have a 24-hour urine collection with a < protein content in the urine within 24 hours 1 g (If both test methods are adopted, the eligibility will be determined using the results of a 24-hour urine collection); 5) Coagulation function: International normalized ratio (INR) <=1.5 × ULN, and activated partial thromboplastin time (APTT) <=1.5 × ULN (except for those receiving therapeutic anticoagulant treatment). (8) Female subjects of childbearing potential must have a urine or serum pregnancy test within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must agree to strictly use effective contraception throughout the treatment period and for 6 months after the tre
Exclusion criteria
Exclusion criteria: 1. Previously received T-cell immune checkpoint inhibitors (including but not limited to anti-PD-1/PD-L1 monoclonal antibodies or combination antibodies, anti-CTLA-4 monoclonal antibodies or combination antibodies); 2. Received local tumor therapy within 4 weeks prior to first dose; 3. History of or concomitant interstitial pneumonia, severe chronic obstructive pulmonary disease, severe lung dysfunction, symptomatic bronchospasm, or similar conditions; 4. History of other primary malignant tumors; (1) Note: Basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix are excluded; (2) Patients who have received radical treatment and have not had recurrence within 5 years can participate in this trial; 5. Previously experienced severe allergic reactions to the active or inactive ingredients of the investigational drug; 6. All acute toxicity reactions from previous antitumor treatments or surgeries have resolved to 10 mg/day of prednisone or equivalent), and continued use within 2 weeks prior to enrollment. Exceptions include: (1) Clinically stable autoimmune thyroid disease; (2) Type I diabetes on hormone replacement therapy; (3) Autoimmune skin diseases well controlled through local treatment (such as low-dose topical steroids) without acute exacerbations requiring additional treatment within 12 months prior to screening (e.g., eczema, psoriasis, chronic simple lichen, or vitiligo involving 160 mmHg or diastolic BP >100 mmHg), history of hypertensive crisis or hypertensive encephalopathy, poorly controlled diabetes, or signs of active bleeding; 9. Poorly controlled cardiac disease, including: (1) History of myocarditis, heart failure NYHA class 2 or higher, or echocardiographic evidence of LVEF (left ventricular ejection fraction) 450 ms (male) or QTcF >470 ms (female); 10. Evidence of active infection, including but not limited to hepatitis B (meeting both criteria of HBsAg positivity and HBV DNA >=2000 IU/mL, excluding drug- or other cause-related hepatitis), hepatitis C (meeting both anti-HCV antibody positivity and HCV RNA positivity), or human immunodeficiency virus (HIV) infection; 11. Patients with active central nervous system metastases, spinal cord compression, carcinomatous meningitis, or history of leptomeningeal metastases (except for patients who are asymptomatic or have received treatment and are stable, i.e., no new or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Disease Control Rate (DCR);Overall Survival (OS);Duration of Response (DOR); | — |
Countries
China
Contacts
Public ContactLiu Jiayong
Beijing Cancer Hospital
Outcome results
None listed