An Exploratory Clinical Study of Short Course Radiotherapy Combined With Surufatinib and Sintilimab in the Treatment of Relapsed and Refractory Advanced Solid Tumors

Wuhan Union Hospital, China1 site in 1 country36 target enrollmentSeptember 30, 2022

ConditionsUnresectable Advanced Solid Tumors Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer

InterventionsSurufatinib Sintilimab Short course radiotherapy

DrugsSurufatinib Sintilimab

Overview

Phase: Phase 2
Intervention: Surufatinib
Conditions: Unresectable Advanced Solid Tumors
Sponsor: Wuhan Union Hospital, China
Enrollment: 36
Locations: 1
Primary Endpoint: Progression-free Survival (PFS)
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 30, 2022

End Date

September 30, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wuhan Union Hospital, China

Responsible Party

Principal Investigator

Xiaorong Dong

Director

Wuhan Union Hospital, China

Eligibility Criteria

Inclusion Criteria

•Age 18-75 years (including 18 and 75 years), both genders;
•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;
•The lesions can be clearly evaluated by imaging;
•Expected survival ≥ 12 weeks;
•No serious abnormalities of blood system, heart, lung, liver, kidney function or immune deficiency;
•Laboratory tests (without blood transfusion within 14 days) shall meet the following requirements:
•If a fertile man or woman is willing to use contraception during the trial;
•Physical status score ECOG 0-1;
•Patients or their family members agreed to participate in the study and signed the informed consent form;

Exclusion Criteria

•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.);
•Women who are breast feeding, pregnant or preparing to become pregnant;
•Corticosteroids (dose equivalent to prednisone \& GT; 10 mg/ day) or other immunosuppressive therapy;
•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);
•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);
•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;
•Allergic constitution and multiple drug allergy;
•Patients judged by other investigators to be unable to tolerate chemotherapy or not suitable for inclusion.

Arms & Interventions

Surufatinib Combined With Sintilimab and SCRT

Intervention: Surufatinib

Surufatinib Combined With Sintilimab and SCRT

Intervention: Sintilimab

Surufatinib Combined With Sintilimab and SCRT

Intervention: Short course radiotherapy

Outcomes

Primary Outcomes

Progression-free Survival (PFS)

Time Frame: 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 Outcomes

Objective response rate (ORR)(From Baseline to primary completion date, about 24 months)
Overall survival (OS)(From the time of enrollment to death caused by any reason)
Disease Control Rate(From Baseline to primary completion date, about 24 months)
The incidence of adverse events(From Baseline to primary completion date, about 24 months)