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

Phase 2

Not yet recruiting

• Conditions: Unresectable Advanced Solid Tumors; Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer
• Interventions: Drug: Surufatinib; Drug: Sintilimab; Radiation: Short course radiotherapy

• Registration Number: NCT05527821
• Lead Sponsor: Wuhan Union Hospital, China

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Study Start: 2022-09-30
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surufatinib Combined With Sintilimab and SCRT	Short course radiotherapy	-
Surufatinib Combined With Sintilimab and SCRT	Surufatinib	-
Surufatinib Combined With Sintilimab and SCRT	Sintilimab	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	From Baseline to primary completion date, about 24 months	A duration from the date of initial treatment to disease progression or death of any cause

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	From Baseline to primary completion date, about 24 months	The incidence of confirmed complete response or partial response
Overall survival (OS)	From the time of enrollment to death caused by any reason	From Baseline to primary completion date, about 24 months
Disease Control Rate	From Baseline to primary completion date, about 24 months	The incidence of complete response, partial response and stable disease
The incidence of adverse events	From Baseline to primary completion date, about 24 months	The safety and tolerability of Surufatinib will be evaluated based on adverse events data

Trial Locations

Locations (1)

Union hospital; 🇨🇳 Wuhan, Hubei, China