Study of Surufatinib Combined With Sintilimab and SCRT in Advanced Solid Tumors

Launched by WUHAN UNION HOSPITAL, CHINA · Sep 1, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with advanced solid tumors that cannot be surgically removed. Specifically, it tests a combination of two drugs, surufatinib and sintilimab, along with a short course of radiation therapy. These treatments are being studied for patients who have already tried standard therapies but did not have success. The trial is open to adults aged 18 to 75 years with certain types of cancers, including biliary tract tumors, gastric cancer, and small cell lung cancer, as long as they are in good overall health and have a life expectancy of at least 12 weeks.

If you or a family member are considering participation, you should know that the trial is not yet recruiting participants. Before joining, potential participants will need to meet specific criteria, such as having confirmed advanced cancer and no serious health issues that could complicate treatment. Those who qualify will receive the study treatments and will be closely monitored for their health and any side effects. It’s important to discuss the decision to participate with a healthcare provider to understand both the potential benefits and risks.

Gender

ALL

Eligibility 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.