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

May 8, 2024 updated by: Jiangsu HengRui Medicine Co., Ltd.

HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

778

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Yupei Zhao
        • Principal Investigator:
          • Wenming Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ECOG performance status 0 or 1
  2. Histological or cytologically confirmed pancreatic cancer that has not been previously treated 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 evaluation criteria for pancreatic cancer (RECIST 1.1)
  5. Able and willing to provide a written informed consent

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, 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;
  4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate
Active Comparator: nab-paclitaxel; gemcitabine
Drug: nab-paclitaxel; gemcitabine
nab-paclitaxel in combination with gemcitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment)
From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response rate (ORR)
Time Frame: up to 6 months following the date the last patient was randomized
ORR is defined as the percentage of participants who have a best overall response of complete response (CR) or partial response (PR), per RECIST 1.1.
up to 6 months following the date the last patient was randomized
Disease Control Rate
Time Frame: up to 6 months following the date the last patient was randomized
The study is designed to evaluate the disease control rate with advanced pancreatic cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD).
up to 6 months following the date the last patient was randomized
Duration of Response
Time Frame: up to 6 months following the date the last patient was randomized
DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier.
up to 6 months following the date the last patient was randomized
Progression free survival (PFS)
Time Frame: 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
PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR070803-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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