A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer

Sponsor
RenJi Hospital
Study ID
NCT04674956
Phase
PHASE3
Status
Unknown

Conditions

  • Pancreatic Cancer Metastatic
  • Pancreatic Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    PD-1 antibody（Camrelizumab）, 200mg, D1; every 21 days as a cycle.
  • Paclitaxel(Albumin Bound) and Gemcitabine — DRUG
    Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.
  • Placebo — DRUG
    Placebo, 200mg, D1; every 21 days as a cycle.

Study Details

Aim：Evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer. Drug information： * anti-PD1 antibody (Camrelizumab) * AG regimens：the standard first-line regimens for metastatic pancreatic cancer.

Key Dates

Start date
Mar 4, 2021
Status verified
Mar 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Treatment arm
    Regimens：anti-PD1 antibody and AG regimens.
  • Placebo Comparator: Control arm
    Regimens：Placebo and AG regimens.

Primary Outcome Measure

Progress free survival [ Time Frame: 3 years ]

Central Contacts

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