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

Primary Purpose

First-line Treatment of Advanced Pancreatic Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
nab-paclitaxel; gemcitabine
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for First-line Treatment of Advanced Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate

nab-paclitaxel; gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

Overall survival (OS)

Secondary Outcome Measures

Objective Response rate (ORR)
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.
Disease Control Rate
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).
Duration of Response
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.
Progression free survival (PFS)
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.

Full Information

First Posted
February 20, 2023
Last Updated
June 27, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05751850
Brief Title
HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First-line Treatment of Advanced Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
HR070803 in combination with oxaliplatin, 5-FU/LV compared with AG
Masking
None (Open Label)
Allocation
Randomized
Enrollment
522 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Arm Type
Experimental
Arm Title
nab-paclitaxel; gemcitabine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Intervention Description
HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel; gemcitabine
Intervention Description
nab-paclitaxel in combination with gemcitabine
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment)
Secondary Outcome Measure Information:
Title
Objective Response rate (ORR)
Description
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.
Time Frame
up to 6 months following the date the last patient was randomized
Title
Disease Control Rate
Description
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).
Time Frame
up to 6 months following the date the last patient was randomized
Title
Duration of Response
Description
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.
Time Frame
up to 6 months following the date the last patient was randomized
Title
Progression free survival (PFS)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhang
Phone
0518-82342973
Email
Jun.zhang@hengrui.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yupei Zhao
First Name & Middle Initial & Last Name & Degree
Wenming Wu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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