A Open-label, Single-arm, Single-center, Phase II Clinical Study of Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer

Sun Yat-sen University1 site in 1 country22 target enrollmentJanuary 30, 2023

ConditionsPancreatic Neoplasms

InterventionsSurufatinib TAS-102

DrugsSurufatinib TAS-102

Overview

Phase: Phase 2
Intervention: Surufatinib
Conditions: Pancreatic Neoplasms
Sponsor: Sun Yat-sen University
Enrollment: 22
Locations: 1
Primary Endpoint: Progression-Free Survival (PFS)
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, single-arm, open-label, phase 2 clinical study, to explore the efficacy and safety of surufatinib combined with TAS-102 in third-line and later-line therapy of patients with advanced pancreatic cancer

Detailed Description

surufatinib:250mg,QD,Q4W TAS-102:35mg/m2,D1-5,D8-12,Q4W

Registry

clinicaltrials.gov

Start Date

January 30, 2023

End Date

May 10, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Dong sheng Zhang

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Informed consent has been signed
•Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic cancer
•Age ≥ 18 years, ≤75 years, male or female
•ECOG PS：0-1, expected overall survival ≥12 months
•Patients who have previously received at least two systemic therapies for locally advanced or metastatic pancreatic cancer; patients with BRCA1/2 germline mutations have previously received platinum-containing regimens
•Patients must have at least one measurable liver metastases (RECIST 1.1)
•No serious organic diseases of the heart, lungs, brain and other organs
•Patients must have adequate organ and bone marrow function
•Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration

Exclusion Criteria

•Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment
•Previously received VEGFR inhibitors or immune checkpoint inhibitors
•Patients had other malignant tumors in the past 5 years, except for the cured skin basal cell carcinoma and cervical carcinoma in situ
•Patients previously had brain metastasis or current brain metastasis
•Received any operation (except biopsy) or invasive treatment or operation (except venous catheterization, puncture and drainage, internal/external drainage surgery for obstructive jaundice, etc.) within 4 weeks before enrollment
•Clinically significant electrolyte abnormality
•Patient currently has uncontrolled hypertension, defined as: systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg
•Proteinuria ≥ 2+ (1.0g/24hr)
•Patients whose tumor is highly likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study as judged by the investigator
•Have evidence or history of bleeding tendency within 3 months, significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment

Arms & Interventions

surufatinib combined with TAS-102

Surufatinib 250mg,TAS-102 35mg/m2

Intervention: Surufatinib

surufatinib combined with TAS-102

Surufatinib 250mg,TAS-102 35mg/m2

Intervention: TAS-102

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Time Frame: up to 24 months

PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator