advanced solid tumors
Conditions
Interventions
Experimental group:short course radiotherapy combined with surufatinib and sintilimab
Sponsors
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years (including 18 and 75 years), both genders; 2. Unresectable malignant tumors confirmed by histology or cytology (mainly biliary tract tumors, gastric cancer, small cell lung cancer, and other tumor types were included as appropriate), which failed at least after first-line standard treatment; 3. The lesions can be clearly evaluated by imaging; 4. Expected survival >= 12 weeks; 5. No serious abnormalities of blood system, heart, lung, liver, kidney function or immune deficiency; 6. Laboratory tests (without blood transfusion within 14 days) shall meet the following requirements: A. Hemoglobin (Hb) >= 90g/L; White blood cell (WBC) >= 3 x 10^9/L; Neutrophil (ANC) >= 1.5 x 10^9/L; Platelet (Pt) >= 100 x 10^9/L; B. Bilirubin = 50mL/min; D. Thyroid stimulating hormone (TSH) <= upper limit of normal value (ULN) (if abnormal, FT3 and FT4 levels should be referred to at the same time, if FT3 and FT4 are normal, you can also be enrolled); 7. If a fertile man or woman is willing to use contraception during the trial; 8. Physical status score ECOG 0-1; 9. Patients or their family members agreed to participate in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with anti-VEGF/VEGFR-targeted drugs, such as soventinib; Or previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another stimulatory or synergistic inhibition of T-cell receptors (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.); 2. Women who are breastfeeding, pregnant or preparing to become pregnant; 3. Corticosteroids (dose equivalent to prednisone >10 mg/ day) or other immunosuppressive agents should be administered within 2 weeks before the study drug administration; 4. Active, known or suspected autoimmune diseases or before 2 years of the history of the disease (in nearly 2 years can be treated as system of vitiligo, psoriasis, hair loss, or graves disease, need only thyroid hormone replacement therapy for hypothyroidism and only need insulin replacement therapy in patients with type 1 diabetes can group); 5. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; Persons with HIV infection or active hepatitis b or c (active hepatitis b reference: HBV DNA>= 1 x 10^4 copies /ml or >= 2000IU/ml; Active hepatitis C reference: HCV RNA>= 1 x10^3 copies /ml); 6. Interstitial lung disease (including past history and current condition), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI; 7. Allergic constitution and multiple drug allergy; 8. Patients judged by other investigators to be unable to tolerate chemotherapy or not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Objective response rate (ORR);Disease control rate (DCR);Safety profile; | — |
Countries
China
Contacts
Public ContactXiaorong Dong
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed