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
Study ID
NCT05988372
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine — DRUG
    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
  • Albumin-paclitaxel + Gemcitabine — DRUG
    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

Study Details

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.

Key Dates

Start date
Oct 23, 2023
Status verified
Oct 2023
Primary completion
Oct 23, 2023
Completion
Oct 23, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine
    enrolled, eligible patients receive Surufatinib, Serplulimab, Gemcitabine and Albumin-paclitaxel
  • Experimental: Albumin-paclitaxel + Gemcitabine
    enrolled, eligible patients receive Gemcitabine and Albumin-paclitaxel

Primary Outcome Measure

R0 Surgical Resection Rate [ Time Frame: Up to 2 years ]

Central Contacts

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