Recurrent or metastatic small round cell sarcoma and other HER2-aberrant solid tumors.
Conditions
Interventions
Group A1:irinotecan liposome (II) in combination with anlotinib
Group A2:irinotecan liposome (II) in combination with anlotinib
Group B:Trastuzumab Rezetecan
Group C:Trastuzumab Rezetecan
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=8 years, no gender restriction; 2. Resectable small round cell sarcoma or other HER2-abnormal solid tumors with confirmed metastasis or recurrence by histological or cytological examination, having received at least one line of prior treatment, experiencing disease progression or treatment intolerance, and for whom the investigator determines there is potential benefit from this treatment regimen; 3. At least one measurable lesion (RECIST v1.1); 4. ECOG: 0–1; 5. Expected survival period >=3 months; 6. The functions of major organs are intact, meaning the following criteria are met (no administration of blood components or cell growth factors within 14 days prior to enrollment): (1) Neutrophils >=1.5×10^9/L; platelets >=80×10^9/L; hemoglobin >=80 g/L; serum albumin >=30 g/L; (2) Total bilirubin = 60 mL/min; (4) INR =50%; 7. Women of childbearing age must undergo a blood pregnancy test within 3 days prior to enrollment, with a negative result, and agree to use appropriate contraceptive methods during the trial period and for 6 months after treatment completion. For men, consent must be obtained to use appropriate contraceptive methods during the study period and for 3 months after treatment completion; 8. Participants voluntarily enrolled in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with known central nervous system metastases; 2.Patients with known central nervous system metastases; 3.Patients currently presenting with interstitial pneumonia or interstitial lung disease, those with a history of interstitial pneumonia or interstitial lung disease requiring corticosteroid therapy, or individuals with pulmonary fibrosis, organizing pneumonia (e.g., obstructive bronchiolitis), pneumoconiosis, drug-induced pneumonia, idiopathic pneumonia, or those whose chest CT during screening reveals active pneumonia or severe pulmonary dysfunction; active tuberculosis; 4.Patients with active autoimmune diseases or a history of autoimmune diseases at risk of recurrence [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (only subjects whose conditions can be controlled through hormone replacement therapy are eligible); those with non-systemically treatable dermatological conditions such as vitiligo, psoriasis, or alopecia; patients with type 1 diabetes under insulin control; or those who have achieved complete remission from childhood asthma without requiring subsequent intervention in adulthood may also be enrolled]; 5.Known peripheral neuropathy (CTCAE grade >= 3); 6.Known deficiency or low activity of dihydroimidazoline dehydrogenase; 7.A history of severe infection (CTCAE grade>2) within 4 weeks prior to enrollment, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; or presence of symptoms and signs of infection within 2 weeks prior to enrollment that necessitated intravenous antibiotic therapy (excluding prophylactic antibiotic use). 8.Has received any of the following treatments: Concomitant medications within 2 weeks prior to enrollment contained strong inhibitors/inhibitors of CYP3A4/CYP2C8 or strong inhibitors of UGT1A1; Patients were receiving immunosuppressive therapy or systemic corticosteroid treatment (dose>10 mg/day of prednisone or other equally effective corticosteroids) for at least 2 weeks prior to enrollment to achieve immunosuppression; Had received radiotherapy within 2 weeks prior to enrollment; Undergoing major surgery (e.g., thoracotomy or laparotomy) within 4 weeks prior to enrollment; Patients must not have received any other investigational drug treatment within 4 weeks prior to enrollment, except for observation (non-interventional) clinical studies or follow-up in intervention-based clinical trials. 9.Patients with coagulation disorders, bleeding tendencies, or those undergoing thrombolytic or anticoagulant therapy are permitted to receive prophylactic low-dose aspirin (=100 mg/day) and low-molecular-weight heparin (enoxaparin 40 mg/day or other low-molecular-weight heparins at equivalent doses); 10.Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction (MI) occurring within the past 6 months; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 11.History of malignant tumors other than relapsed/refractory soft tissue sarcoma within the preceding 3 years, excluding well-treated carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin without signs of recurrence; 12.ndividuals known to be allergic to irinotecan liposomes (II)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Progression Free Survival, PFS; | — |
Countries
China
Contacts
Public ContactMeiyu Fang
Zhejiang Cancer Hospital
Outcome results
None listed