Nivolumab Adding on Gemcitabine/S-1 in Metastatic Pancreatic Cancer

Sponsor
National Taiwan University Hospital
Study ID
NCT04377048
Phase
PHASE2
Status
Unknown

Conditions

  • Stage IV Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    as described in "NGS Arm"
  • Gemcitabine — DRUG
    as described in "NGS Arm"
  • Tegafur-Gimeracil-Oteracil — DRUG
    as described in "NGS Arm"

Study Details

This study assumes that to achieve significant therapeutic efficacy in advanced pancreatic cancer with immunotherapy, the immune system must remain relatively intact. Therefore, early use, low tumor load, adequate organ function, and slow growth of the tumor are the key points. Stage IV pancreatic adenocarcinoma patients with limited metastatic lesions and adequate organ function will be enrolled. Gemcitabine plus S-1 (GS) will be administered initially, and then CA 19-9 will be evaluated. Those fulfilling pre-defined criteria of CA 19-9 will receive nivolumab add-on therapy.

Key Dates

Start date
Jul 1, 2020
Status verified
May 2020
Primary completion
Jul 1, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab/GS
    Part-1: GS Induction * Patients will receive GS for 1 cycle. * S-1: 60/80/100 mg per day (based on body surface area, BSA); D1-12; 3 weeks per cycle * BSA \< 1.25 m2: 60 mg/day; 1.25 m2 ≤ BSA \< 1.5 m2: 80 mg/day; BSA ≥ 1.5 m2: 100 mg/day * Gemcitabine: 850 mg/m2; D1, 8; 3 weeks per cycle * After GS, patients fulfilling the pre-defined CA 19-9 criteria will enter the Add-On part. Part-2: Nivolumab Add-On * Nivolumab: 3 mg/kg every 2 weeks, 6 weeks per cycle * S-1: according to the individualized dose on D8 of cycle 1 in Part-1, 6 weeks per cycle * Gemcitabine: according to the individualized dose on D8 of cycle 1 in Part-1, 6 weeks per cycle The treatment will be continued until disease progression, intolerance to study treatment or death.

Primary Outcome Measure

response rate [ Time Frame: 6 weeks ]

Central Contacts

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