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

Huazhong University of Science and Technology

Status and phase: Not yet enrolling; Phase 2

Conditions: Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer; Unresectable Advanced Solid Tumors

Treatments: Drug: Surufatinib; Radiation: Short course radiotherapy; Drug: Sintilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT05527821

HMPL-012-SPRING-ST101

Details and patient eligibility

About

An exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumors

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Surufatinib Combined With Sintilimab and SCRT

Experimental group

Treatment:

Drug: Surufatinib

Radiation: Short course radiotherapy

Drug: Sintilimab