Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer

Sponsor
Chinese PLA General Hospital
Study ID
NCT05218889
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Pancreas Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms

Eligibility Criteria

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

Interventions

  • surufatinib + camrelizumab + nab-paclitaxel + S-1 — DRUG
    phase 1b: surufatinib 200 or 250 mg/d, qd po; camrelizumab: 200mg, I.V., D1, Q3W; nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; S-1: 40mg bid, D1-14, Q3W; DLTs will be evaluated at first cycle; phase 2: surufatinib RP2D + camrelizumab + nab-paclitaxel + S-1 when evaluated SD, PR or CR after 4-6 cycles (according to RECIST 1.1), followed by maintenance treatment: surufatinib + camrelizumab + S-1
  • nab-paclitaxel + gemcitabine — DRUG
    nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W

Study Details

This study is designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS (nab-paclitaxel and S-1) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in unresectable advanced or metastatic pancreatic cancer.

Key Dates

Start date
Aug 4, 2021
Status verified
Dec 2024
Primary completion
Dec 16, 2024
Completion
Jun 30, 2025

Study Design

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

Arms

  • Experimental: surufatinib + camrelizumab + nab-paclitaxel + S-1
  • Active Comparator: nab-paclitaxel + gemcitabine

Primary Outcome Measure

DLTs [ Time Frame: Up to 21 days after the first dose of surufatinib ]

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