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

NCT04365049 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-02-22

No results posted yet for this study

Summary

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)

Conditions

  • PDAC - Pancreatic Ductal Adenocarcinoma

Interventions

RADIATION

Radiotherapy

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.

DRUG

Nab-paclitaxel

Eight 21-day cycles of nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins on days 1 and 8.

DRUG

Gemcitabine

Eight 21-day cycles of gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8.

DRUG

Camrelizumab

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Kuang, PhD · First Affiliated Hospital, Sun Yat-Sen University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365049 on ClinicalTrials.gov