A Single-center, Single-arm, Phase II Clinical Study of Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer

Sun Yat-sen University1 site in 1 country32 target enrollmentDecember 12, 2022

ConditionsPancreatic Neoplasms

InterventionsSurufatinib Sintilimab AG

DrugsSurufatinib Sintilimab AG

Overview

Phase: Phase 2
Intervention: Surufatinib
Conditions: Pancreatic Neoplasms
Sponsor: Sun Yat-sen University
Enrollment: 32
Locations: 1
Primary Endpoint: objective response rate (ORR)
Status: Active, not recruiting
Last Updated: 8 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 sintilimab and AG in first-line therapy of patients with locally advanced or metastatic pancreatic cancer.

Registry

clinicaltrials.gov

Start Date

December 12, 2022

End Date

December 31, 2026

Last Updated

8 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 not previously received systemic therapy for locally advanced or metastatic pancreatic cancer
•Patients with distant metastases after surgery, who have received one regimen of adjuvant chemotherapy and have recurred \> 6 months from adjuvant therapy can be enrolled
•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 with BRCA1/2 germline mutations
•Patients with obstructive jaundice but less than expected jaundice
•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
•Investigator determines that the liver metastases account for 70% or more of the total liver volume
•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
•Received local anti-tumor therapy such as hepatic artery interventional embolization, cryoablation or radiofrequency ablation of liver metastases within 4 weeks before enrollment
•Clinically significant electrolyte abnormality

Arms & Interventions

surufatinib combined with sintilimab and AG

Intervention: Surufatinib

surufatinib combined with sintilimab and AG

Intervention: Sintilimab

surufatinib combined with sintilimab and AG

Intervention: AG

Outcomes

Primary Outcomes

objective response rate (ORR)

Time Frame: up to 24 months

Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

Secondary Outcomes

adverse events (AE)(up to 24 months)
Progression-Free Survival (PFS)(up to 24 months)
Molecular markers and imaging parameters predicting therapeutic efficacy(up to 24 months)
disease control rate (DCR)(up to 24 months)
overall survival (OS)(up to 24 months)