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

NCT05751850 | Recruiting Phase 3

• 1 other identifier: HR070803-301
• Study Type: interventional
• Target: 778
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

First-line Treatment of Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment)

Secondary Outcomes (4)

• Objective Response rate (ORR)

  up to 6 months following the date the last patient was randomized

• Disease Control Rate

  up to 6 months following the date the last patient was randomized

• Duration of Response

  up to 6 months following the date the last patient was randomized

• Progression free survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Study Arms (2)

HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

EXPERIMENTAL

Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

nab-paclitaxel; gemcitabine

ACTIVE COMPARATOR

Drug: nab-paclitaxel; gemcitabine

Interventions

HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate DRUG

HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate

HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

nab-paclitaxel; gemcitabine DRUG

nab-paclitaxel in combination with gemcitabine

nab-paclitaxel; gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; 130-nm albumin-bound paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Central Study Contacts

Jun Zhang

CONTACT

0518-82342973; Jun.zhang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HR070803 in combination with oxaliplatin, 5-FU/LV compared with AG

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: June 13, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

CN (1)