First-line Treatment of Advanced Pancreatic CancerPhase 3NCT05751850
HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer
A Phase 3 study testing HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate and nab-paclitaxel; gemcitabine in people with First-line Treatment of Advanced Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- First-line Treatment of Advanced Pancreatic Cancer
- What is being tested?
- HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate and nab-paclitaxel; gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 778 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2023to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100142
Yupei Zhao
Wenming Wu
About this study
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.
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.
- Being tested
- HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate, nab-paclitaxel; gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinateDrug
HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate
nab-paclitaxel; gemcitabineDrug
nab-paclitaxel in combination with gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate | Experimental | Not described Receives: Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate |
| nab-paclitaxel; gemcitabine | Active comparator | Not described Receives: Drug: nab-paclitaxel; gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment)
Secondary outcomes (4)
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.
Measured: up to 6 months following the date the last patient was randomized
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).
Measured: up to 6 months following the date the last patient was randomized
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.
Measured: up to 6 months following the date the last patient was randomized
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start13 Jun 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First-line Treatment of Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HR070803 in combination with oxaliplatin, 5-FU/LV compared with AG
- Masking
- None (open label)
- Enrolment
- 778 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751850
- Sponsor's protocol ID
- HR070803-301
- Status last verified
- May 2024
- First submitted
- 20 Feb 2023
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05751850
- Acronym / sponsor ID
- HR070803-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 778 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- HR070803 in combination with oxaliplatin, 5-FU/LV compared with AG
| Arm | Type | Receives |
|---|---|---|
| HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate | Experimental | Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate |
| nab-paclitaxel; gemcitabine | Active comparator | Drug: nab-paclitaxel; gemcitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinateHR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate | Drug | HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate |
| nab-paclitaxel; gemcitabinenab-paclitaxel in combination with gemcitabine | Drug | nab-paclitaxel; gemcitabine |
Primary outcome
Overall survival (OS)
Time frame: From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment)
4 secondary outcomes
Objective Response rate (ORR)
Time frame: 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
Duration of Response
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate and nab-paclitaxel; gemcitabine in people with First-line Treatment of Advanced Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhang (0518-82342973, Jun.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.