Sarcoma
Conditions
Interventions
Experimental group:surufatinib combined with penpulimab
Sponsors
The First Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in the study, signed informed consent, and had good compliance; 2. Body surface area of patients aged 14-70 years (inclusive) and = 1.5m^2; 3. Patients with unresectable stage IIB or III osteosarcoma or soft tissue sarcoma confirmed histologically or cytologically; 4. Patients must have at least one measurable lesion (RECIST 1.1); 5. Patients must have used more than two drug combination chemotherapy regimens; The cumulative dose of doxorubicin should not be less than 300mg/m^2 (including the converted dose) (note: neoadjuvant or adjuvant chemotherapy is permitted in the early stage. If disease progression/recurrence occurs during neoadjuvant/adjuvant therapy or within 6 months after the end of treatment, neoadjuvant/adjuvant therapy is considered a failure of first-line systemic chemotherapy for progressive disease); 6. ECOG physical status 0 or 1 (PS 0-2 for amputees); 7. Expected survival >= 12 weeks;
Exclusion criteria
Exclusion criteria: 1. Received the following treatment within 4 weeks of treatment: radiation therapy for cancer, surgery, chemotherapy, immunotherapy or molecular targeted therapy, and other investigational drugs; 2. Have previously received other piamprizumab therapy or other targeted therapy for PD-1/PD-L1/CTLA-4; Or have previously received anti-vascular small-molecule targeted drug therapy, such as surufatinib; 3. Surgical and/or radiation therapy for soft tissue sarcomas is planned for > 5% of the bone marrow areas during the study period; 4. The patient has current central nervous system (CNS) metastasis or previous brain metastases; 5. Use of immunosuppressive medications within the 14 days prior to the start of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e., prednisolone dose not exceeding 10 mg per day or another physiological equivalent of corticosteroids); 6. A history of any active autoimmune disease or autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma may have complete remission in childhood and do not currently require medical intervention, or a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation); 7. Severe infection (e.g. intravenous infusion of antibiotics, antifungals, or antivirals) within 4 weeks prior to treatment, or unexplained fever > 38.5 ? during screening/initial administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;12-month overall survival rate;safety profile; | — |
Countries
China
Contacts
Public ContactJingnan Shen
Outcome results
None listed