A Single-arm, Single-center, Exploratory Phase II Study of Surufatinib in Patients With Soft Tissue Sarcoma Who Have Failed Anthracycline-containing Chemotherapy and Who Have Been Successfully Targeted With Antivascular Agents

Fudan University0 sites29 target enrollmentNovember 28, 2023

ConditionsSoft Tissue Sarcoma Adult

InterventionsSurufatinib

DrugsSurufatinib

Overview

Phase: N/A
Intervention: Surufatinib
Conditions: Soft Tissue Sarcoma Adult
Sponsor: Fudan University
Enrollment: 29
Primary Endpoint: PFS
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a single-center, open, single-arm, phase II clinical study to investigate the efficacy and safety of patients with soft tissue sarcoma who have failed anthracycline-containing chemotherapy and whose antivascular agents have been effective and failed.

Progression-free survival (PFS) was used as the primary outcome measure to preliminatively estimate the efficacy and safety of 29 patients with soft tissue sarcoma who had failed chemotherapy with anthracyclines and who had received effective and failed antivascular agents. Sofantinib 300mg orally, once a day, with continuous administration every 21 days, until the disease progresses or becomes intolerable; Imaging methods were used every 6 weeks (±7 days) after enrollment according to RECIST1.1 standard to evaluate the efficacy of tumor.

Registry

clinicaltrials.gov

Start Date

November 28, 2023

End Date

August 15, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Zhiguo Luo, MD, PhD

Deputy chief of medical oncology, chief physician，Fudan University Shanghai Cancer Center

Fudan University

Eligibility Criteria

Inclusion Criteria

•Have fully understood the study and voluntarily signed the informed consent;
•Age ≥18 years old;
•Histologically or cytologically confirmed patients with unresectable or metastatic soft tissue sarcoma;
•The patient must have at least one measurable lesion (RECIST1.1);
•Previous failure of anthracycline-containing chemotherapy was defined as disease progression during treatment or within 3 months after the last treatment, or disease progression during adjuvant treatment with anthracycline-containing chemotherapy or within 6 months after adjuvant treatment, and toxic side effects of anthracycline-containing chemotherapy were not tolerated. (Neoadjuvant or adjuvant chemotherapy is allowed in the early stage. If disease progression/recurrence occurs during neoadjuvant/adjuvant therapy or within 6 months after the end of treatment, neoadjuvant/adjuvant therapy is considered a failure of first-line systemic chemotherapy for progressive disease);
•Patients with previous anti-angiogenic efficacy and failure were defined as: tumor progression occurred in SD or above patients after withdrawal of SD (CR/PR) during the course of anti-angiogenic therapy (including anti-angiogenic small molecule inhibitors or monoclonal antibodies), or tumor progression occurred in SD patients over 12 weeks; Or the toxic side effects of treatment are intolerable.
•ECOG physical status 0 or 1 points (PS0-2 points for amputees);
•Expected survival ≥12 weeks;
•Blood test (without blood transfusion within 14 days)
•Neutrophil absolute value ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin concentration ≥9g/dL);

Exclusion Criteria

•Patients who have received previous treatment with Surufatinib;
•Consider toxic reactions associated with anti-vascular targeting drugs if they have previously been intolerable
•Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;
•Received any surgery or invasive treatment or operation (except intravenous catheterization, puncture drainage, etc.) within 4 weeks before enrollment;
•International Standardized Ratio (INR)\>1.5 or partially activated prohemase time (APTT)\>1.5×ULN;
•The investigator identified clinically significant electrolyte abnormalities;
•The patient currently has high blood pressure that cannot be controlled by drugs, which is defined as: systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg;
•Unsatisfactory blood glucose control (FBG \> 10mmol/L);
•The patient has any current disease or condition that affects the absorption of the drug, or the patient cannot take sofantinib orally;
•The patient currently has gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectosed tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation;

Arms & Interventions

surufatinib

surufatinib 300mg orally, once a day, every 21 days for one cycle, treatment until disease progression or intolerance

Intervention: Surufatinib

Outcomes

Primary Outcomes

PFS

Time Frame: PFS is defined as approximately 12 months from the date of enrollment until the date of first recorded progress or the date of death from any cause, whichever comes first

progression-free survival

Secondary Outcomes

ORR(From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
OS(OS From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
DCR(From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)