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NOT YET RECRUITING
NCT05988372
PHASE2

Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a Phase II Randomized Controlled PILOT clinical study. The purpose of this study is to explore the efficacy and safety of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine in the conversion therapy for patients with unresectable locally advanced pancreatic cancer. Furthermore, it compares the efficacy of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine to the albumin-paclitaxel and gemcitabine regimen in the conversion therapy for patients with unresectable locally advanced pancreatic cancer.

Official title: Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer : a Phase II Randomized Controlled PILOT Study (SAGE)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-10-23

Completion Date

2026-10-23

Last Updated

2023-11-01

Healthy Volunteers

No

Interventions

DRUG

Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine

Surufatinib:250mg orally once a day for 3 weeks(3 weeks 1 cycle) Serplulimab:4.5mg/Kg by intravenous infusions on day1 every 3 weeks Albumin-paclitaxel:125mg/m2 by intravenous infusions on day1 and 8 every 3 weeks Gemcitabine:1000mg/m2 by intravenous infusions on day1 and 8 every 3 weeks

DRUG

Albumin-paclitaxel + Gemcitabine

Albumin-paclitaxel:125mg/m2 by intravenous infusions on day1 and 8 every 3 weeks Gemcitabine:1000mg/m2 by intravenous infusions on day1 and 8 every 3 weeks

Locations (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China