Overview
Study of Surufatinib Combined With Sintilimab and SCRT in Advanced Solid Tumors
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-09-30
2025-09-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
An exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumorsPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Wuhan Union Hospital, China
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:
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:
1. Previous treatment with anti-VEGF/VEGFR-targeted drugs, such as surufatinib; 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 breast feeding, pregnant or preparing to become pregnant;
3. Corticosteroids (dose equivalent to prednisone & GT; 10 mg/ day) or other
immunosuppressive therapy;
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. 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≥1×104 copies /ml or ≥2000IU/ml; Active hepatitis C
reference: HCV RNA≥1×103 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.