HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer

Last updated: May 8, 2024
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Treatment

HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

nab-paclitaxel; gemcitabine

Clinical Study ID

NCT05751850
HR070803-301
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to look at the efficacy and safety of HR070803 in combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ECOG performance status 0 or 1
  2. Histological or cytologically confirmed pancreatic cancer that has not been previouslytreated in the metastatic disease.
  3. Life expectancy of greater than or equal to3 months.
  4. At least one measurable lesion is present according to the efficacy evaluationcriteria for pancreatic cancer (RECIST 1.1)
  5. Able and willing to provide a written informed consent

Exclusion

Exclusion Criteria:

  1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium,including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas,pancreatoblastoma, and solid-pseudopapillary tumor;
  2. Known history of central nervous system (CNS) metastases.
  3. Severe infection (> CTCAE grade 2), such as severe pneumonia, bacteremia, infectioncomplications, etc. requiring inpatient treatment, occurred within four weeks beforeenrollment, and symptoms and signs of infection requiring intravenous antibiotictherapy (except for prophylactic antibiotics) occurred within two weeks beforeenrollment;
  4. Patients with cardiac clinical symptoms or diseases that are not well controlled, suchas: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3)myocardial infarction that occurred within 6 months; (4) clinically significantsupraventricular or ventricular arrhythmia requiring treatment or intervention.

Study Design

Total Participants: 778
Treatment Group(s): 2
Primary Treatment: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Phase: 3
Study Start date:
June 13, 2023
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

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