Pathologically confirmed distant metastasis or locally advanced soft tissue sarcoma who are ineligible for surgical treatment
Conditions
Interventions
single arm:1) Recombinant Human Adenovirus Type 5 Injection
2) Iparomlimab and Tuvonralimab (PD-1/CTLA-4 Antibody)
3) Investigator-Selected Treatment Regimen
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–75 years; 2.BMI (Body Mass Index) >=18.5; 3.ECOG PS score 0–1; 4.Expected survival >=3 months; 5.Patients with pathologically confirmed soft tissue sarcoma with distant metastasis or locally advanced disease unsuitable for surgical treatment; 6.At least one measurable lesion >=1 cm; 7.At least one lesion >=1 cm suitable for oncolytic virus injection, located in accessible areas such as extremities, trunk, abdominal/pelvic cavity, or visceral organs; 8.Normal major organ function meeting the following criteria within 7 days prior to treatment: (1)Blood counts must meet the following criteria (without transfusion of blood or blood products within 14 days, and without correction using G-CSF or other hematopoietic growth factors): a) Hemoglobin (HB) >= 90 g/L; b) Absolute neutrophil count (ANC) >= 1.5 × 10?/L; c) Platelets (PLT) >= 75 × 10?/L (2)Biochemical tests must meet the following criteria: a) Total bilirubin (TBIL) = 60 mL/min; d) Albumin (ALB) >= 35 g/L e) Urine protein = lower limit of normal (50%); 9.Women of childbearing potential must be using reliable contraception or have undergone a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last study drug administration, or be sterilized. For males, consent to use appropriate contraception during the trial and for 8 weeks after the last study drug administration, or be surgically sterilized, is required.
Exclusion criteria
Exclusion criteria: 1.Previous treatment with dual PD-1/CTLA-4 antibodies (may include patients treated with either PD-1 or CTLA-4 monotherapy); 2.Major surgery within 4 weeks prior to enrollment; 3.Imaging-confirmed central nervous system metastases; 4.Long-term use of immunosuppressive drugs or systemic corticosteroids (>10 mg daily prednisone equivalent); topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted; 5.History of any active immune or autoimmune disease, or known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6.Active or uncontrolled severe infection (>=CTCAE Grade 2) within 4 weeks prior to enrollment; 7.History of hypertension that remains poorly controlled despite medication (systolic blood pressure >=150 mmHg or diastolic blood pressure >=90 mmHg); 8.Significant clinically relevant bleeding events or documented bleeding tendency within 3 months prior to enrollment; Lesions involving hollow organs with risk of hemorrhagic perforation; 9.Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc>=480ms), or Grade >=2 congestive heart failure (New York Heart Association [NYHA] classification) within 6 months prior to enrollment; Any arterial thromboembolic event within 6 months prior to enrollment, including cerebrovascular accident or transient ischemic attack, with a history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event; 10.Diagnosis of other malignancies within 3 years prior to enrollment; however, patients with basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, or other in situ cancers (e.g., cervical/breast) who achieved complete remission after curative surgery and require no further treatment during the study may be considered for enrollment; 11.HIV-positive status; cirrhosis; decompensated liver disease; active hepatitis B (HBsAg positive with HBV-DNA>=104 copies/mL) or hepatitis C (HCV antibody positive with HCV-RNA quantitative test result above the lower limit of detection); Note: Subjects with active hepatitis B (HBV-DNA < 104 copies/mL) who are willing to receive entecavir or other antiviral therapy during the study based on clinical judgment may be enrolled; 12.Participation in other anticancer drug clinical trials within 4 weeks prior to enrollment; 13.History of psychiatric drug abuse with inability to abstain or presence of psychiatric disorders; 14.Pregnancy confirmed within 7 days prior to first dosing, or lactating women of childbearing potential; 15.Presence of any concomitant disease or other condition judged by the investigator to pose a serious risk to patient safety, potentially confound study results, or interfere with the patient's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate in the virus injection area; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Overall survival;Safety includes: Adverse Events (AE); Serious Adverse Events (SAE);Objective response rate; | — |
Countries
China
Contacts
Public ContactZhou Yuhong
Zhongshan Hospital, Fudan University
Outcome results
None listed