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

NCT ID: NCT05527821

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-09-30

Brief Summary

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surufatinib Combined With Sintilimab and SCRT

Group Type: EXPERIMENTAL

Surufatinib

Intervention Type: DRUG

Surufatinib 250mg will be taken orally once daily continuously on a 21-day cycle

Sintilimab

Intervention Type: DRUG

Sintilimab 200mg will be intravenously administered on Day 1 of each cycle

Short course radiotherapy

Intervention Type: RADIATION

5Gy\*5F short course radiotherapy will be delivered

Interventions

Surufatinib

Surufatinib 250mg will be taken orally once daily continuously on a 21-day cycle

Intervention Type: DRUG

Sintilimab

Sintilimab 200mg will be intravenously administered on Day 1 of each cycle

Intervention Type: DRUG

Short course radiotherapy

5Gy\*5F short course radiotherapy will be delivered

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xiaorong Dong

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Union hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

HMPL-012-SPRING-ST101

Identifier Type: -

Identifier Source: org_study_id