Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy for Locally Advanced Pancreatic Adenocarcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT04365049
Status
Unknown

Conditions

  • PDAC - Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Radiotherapy — RADIATION
    Radiotherapy started after two cycles of chemotherapy. External beam radiation therapy was performed using an intensity modulated radiation therapy technique. The gross target volume included the gross primary tumor and positive regional lymph nodes as defined by the multiphasic imaging. A total radiation dose greater than 50 Gy without damaging organ function was the essential requirement.
  • Nab-paclitaxel — DRUG
    Eight 21-day cycles of nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins on days 1 and 8.
  • Gemcitabine — DRUG
    Eight 21-day cycles of gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8.
  • Camrelizumab — DRUG
    Anti-PD-1 antibody (camrelizumab, Hengrui Medicine Co., Ltd) 200 mg was administered intravenously for 30 mins every three weeks. During the chemotherapy-treated period, camrelizumab was administered on day 1 of each 21-day cycle before the infusion of chemotherapy.

Study Details

The study is a prospective and observational cohort study. The purpose is to to investigate the safety and efficacy of nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy versus nab-paclitaxel and gemcitabine alone for locally advanced pancreatic adenocarcinoma (PDAC)

Key Dates

Start date
Apr 1, 2020
Status verified
Feb 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Nab-Paclitaxel+Gemcitabine+Camrelizumab+Radiotherapy
    Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8). Anti-PD-1 antibody (camrelizumab, Hengrui Medicine Co., Ltd) 200 mg was administered intravenously for 30 mins every three weeks. During the chemotherapy-treated period, camrelizumab was administered on day 1 of each 21-day cycle before the infusion of chemotherapy. Radiotherapy started after two cycles of chemotherapy. A total radiation dose greater than 50 Gy without damaging organ function was the essential requirement.
  • Arm: Nab-Paclitaxel+Gemcitabine
    Chemotherapy consisted of eight 21-day cycles of nab-paclitaxel plus gemcitabine (nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins, followed by gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8).

Primary Outcome Measure

Progression-free survival [ Time Frame: two years ]

Central Contacts

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