Advanced Solid Tumors
Conditions
Interventions
experimental group: breast cancer:Radiotherapy combined with Sintilimab and Chidamide therapy (Sintilimab: 200mg via intravenous infusion every 3 weeks
Chidamide: 30mg orally twice weekly
Radiotherapy: Initiated on day 7 of each Chidamide cycle, with a dose of 5–8 Gy per fraction for 3 fractions).
experimental group:soft tissue sarcoma:Radiotherapy combined with Sintilimab and Chidamide therapy (Sintilimab: 200mg via intravenous infusion every 3 weeks
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study and sign the informed consent form. 2. Age range is 18 to 80 years old, with no gender restrictions. 3. Patients with histologically confirmed recurrent or metastatic HER2-negative breast cancer (HER2-negative IHC-/+ or IHC++ but FISH/CISH-) are enrolled in Cohort A. They must have previously received anthracycline and/or taxane therapy (including neoadjuvant, adjuvant, or metastatic settings), with at least one line of chemotherapy in the recurrent or metastatic setting. If hormone receptor-positive (ER-positive (IHC ER-positive percentage >= 1%), PR-positive (IHC PR-positive percentage >=1%)), patients must have received at least one line of endocrine therapy. 4. Patients with histologically confirmed advanced soft tissue sarcoma who have failed standard treatment are enrolled in Cohort B. 5. Have at least two tumor lesions, with at least one measurable lesion according to RECIST v1.1 criteria. 6. Able to swallow tablets. 7. ECOG score: 0 to 2. 8. Expected survival >= 12 weeks. 9. Assessed by a radiation oncologist as having at least one tumor lesion suitable for large-fraction immunotherapy radiation at 5-8Gy*3f. 10. Vital organ functions must meet the following criteria (excluding the use of any blood components or cell growth factors during the screening period): (1) Absolute neutrophil count >= 1.5 × 10^9/L; (2) Platelets >= 90 × 10^9/L; (3) Hemoglobin >= 9g/dL; (4) Serum albumin >= 3g/dL; (5) Thyroid-stimulating hormone (TSH) = 60mL/min (using the standard Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women (women of childbearing age must have a negative pregnancy test within 14 days prior to the first dose; if positive, pregnancy must be excluded by ultrasound), and women of childbearing age who are unwilling to use effective contraceptive measures during the study. 2. Subjects with any history of other cancers (except for non-melanoma skin cancer or cervical carcinoma in situ) are excluded, unless the patient's tumor has completely resolved and has not received treatment for at least 5 years prior to the enrollment date. 3. Participation in any investigational drug treatment within 4 weeks before the start of treatment. 4. Subjects with symptomatic central nervous system metastases. Patients with stable, asymptomatic brain metastases who have received radiotherapy and have at least one evaluable target lesion in other sites, excluding brain metastatic lesions, may be enrolled, but there must be an interval of more than 4 weeks since the last radiotherapy. 5. Major surgery within 4 weeks before enrollment, or surgical wounds that have not healed. 6. Embolic or hemorrhagic events within 4 weeks before enrollment. 7. Severe cardiovascular diseases, including uncontrolled hypertension with medical treatment (BP >= 160/95 mmHg), unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure > NYHA Class II, severe arrhythmias, and pericardial effusion, etc. 8. Severe infection requiring intravenous antibiotics, antifungal, or antiviral therapy. 9. Active autoimmune disease requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is allowed. Known history of primary immunodeficiency. Patients with only positive autoimmune antibodies need to be assessed by the investigator to confirm the presence of autoimmune disease. 10. Use of immunosuppressive drugs within 4 weeks before the first dose, excluding nasal, inhaled, or other topical glucocorticoids or systemic glucocorticoids at physiological doses (i.e., not exceeding 10 mg/day of prednisone or equivalent doses of other glucocorticoids). Temporary use of glucocorticoids for the treatment of dyspnea symptoms in diseases such as asthma or chronic obstructive pulmonary disease is allowed. 11. Known allergy to any PD-1 monoclonal antibody, chidamide; or previous severe allergic reactions to other immune checkpoint inhibitors or histone deacetylase inhibitors. 12. Subjects with mental illness or poor compliance; deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactLi Xie
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed