Pancreatic CancerPhase 3NCT06217042
HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer
A Phase 3 study testing HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate and gemcitabine; capecitabine in people with Pancreatic Cancer, run by Fudan University 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 gemcitabine + capecitabine treatment as adjuvant therapy in patients with resected pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate and gemcitabine; capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 30 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
- Life expectancy of greater than or equal to 6 months.
- Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
- Acceptable hematology parameters and blood chemistry levels.
- 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;
- Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
- CA 19-9> 180 U / ml within 21 days of registration on study.
- Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
- 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. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Gemcitabine in Combination With Capecitabine as Adjuvant Therapy for 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 gemcitabine + capecitabine treatment as adjuvant therapy in patients with resected pancreatic cancer.
Read the detailed description
STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the disease-free survival. Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. Patients without event at the time of analysis will be censored at the date of last follow-up visit.
Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit.
Secondary criteria also include 3-year disease-free survival rate/overall survival rate and 5-year disease-free survival rate/overall survival rate.
Tolerance Patients evaluable for toxicity must have received one investigational drug.
- Conditions
- Pancreatic Cancer
- Being tested
- HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate, gemcitabine; capecitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinateDrug
Oxaliplatin 85 mg/m² D1 over 2 hours, followed by HR070803 60 mg/m² D1 over 90 minutes, after the Folinic acid infusion is started. Folinic acid 400 mg/m² D1, IV infusion over 1 hours. 5-FU 2400 mg/m² D1 IV continuous infusion over 46 hours.
These drugs are given once every 2 weeks, 12 cycles, 24 weeks.
gemcitabine; capecitabineDrug
Gemcitabine 1000mg/m² is given as an i.v. infusion over 30 minutes, administered on day 1, 8 and 15 out of 28 days. Capecitabine 1660mg/m²/day in two divided doses administered orally for 21 days followed by 7 days'rest .
| Study group | Role | What they receive |
|---|---|---|
| HR070803+Oxaliplatin+5-FU/LV | Experimental | HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate Receives: Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate |
| GX | Active comparator | gemcitabine; capecitabine Receives: Drug: gemcitabine; capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause.
Measured: From study start until 338 DFS events have occurred (approximately 21 months after last patient enrollment)
Secondary outcomes (5)
Overall survival (OS)
OS is defined as the time from date of randomization until the date of death from any cause.
Measured: From date of randomization until the date of death from any cause, assessed up to 37 months
3-year disease-free survival rate
Disease-free survival within 3 years
Measured: up to 36 months following the date the first patient was randomized
5-year disease-free survival rate
Disease-free survival within 5 years
Measured: up to 60 months following the date the first patient was randomized
3-year overall survival rate
Overall survival within 3 years
Measured: up to 36 months following the date the first patient was randomized
5-year overall survival rate
Overall survival within 5 years
Measured: up to 60 months following the date the first patient was randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start5 Feb 2024 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Si Shi, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217042
- Sponsor's protocol ID
- HR070803-307
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol and ICF, CSR will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 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 Gemcitabine in Combination With Capecitabine as Adjuvant Therapy for Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.
- ClinicalTrials.gov ID
- NCT06217042
- Acronym / sponsor ID
- HR070803-307
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 22 Jan 2024 (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 gemcitabine + capecitabine treatment as adjuvant therapy in patients with resected pancreatic cancer.
Detailed description
STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the disease-free survival. Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. Patients without event at the time of analysis will be censored at the date of last follow-up visit.
Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit.
Secondary criteria also include 3-year disease-free survival rate/overall survival rate and 5-year disease-free survival rate/overall survival rate.
Tolerance Patients evaluable for toxicity must have received one investigational drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HR070803+Oxaliplatin+5-FU/LV | Experimental | Drug: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinateHR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate |
| GX | Active comparator | Drug: gemcitabine; capecitabinegemcitabine; capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG performance status 0 or 1
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
- Life expectancy of greater than or equal to 6 months.
- Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
- Acceptable hematology parameters and blood chemistry levels.
Key exclusion criteria (6 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;
- Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
- CA 19-9> 180 U / ml within 21 days of registration on study.
- Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
- 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;
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 folinateOxaliplatin 85 mg/m² D1 over 2 hours, followed by HR070803 60 mg/m² D1 over 90 minutes, after the Folinic acid infusion is started. Folinic acid 400 mg/m² D1, IV infusion over 1 hours. 5-FU 2400 mg/m² D1 IV continuous infusion over 46 hours. These drugs are given once every 2 weeks, 12 cycles, 24 weeks. | Drug | HR070803+Oxaliplatin+5-FU/LV |
| gemcitabine; capecitabineGemcitabine 1000mg/m² is given as an i.v. infusion over 30 minutes, administered on day 1, 8 and 15 out of 28 days. Capecitabine 1660mg/m²/day in two divided doses administered orally for 21 days followed by 7 days'rest . | Drug | GX |
Primary outcome
Disease-free survival (DFS)
Time frame: From study start until 338 DFS events have occurred (approximately 21 months after last patient enrollment)
Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause.
5 secondary outcomes
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 37 months
3-year disease-free survival rate
Time frame: up to 36 months following the date the first patient was randomized
5-year disease-free survival rate
Time frame: up to 60 months following the date the first patient was randomized
3-year overall survival rate
Time frame: up to 36 months following the date the first patient was randomized
5-year overall survival rate
Time frame: up to 60 months following the date the first patient was randomized
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Yes. study protocol and ICF, CSR will be shared.
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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.
Si Shi, PhD principal investigator
Fudan University
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 gemcitabine; capecitabine in people with Pancreatic Cancer, run by Fudan University 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 22 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Si Shi, PhD (+86 18917266285, shisi@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: From study start until 338 DFS events have occurred (approximately 21 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 22 Jan 2024.