Efficacy and SafetyPhase 2NCT06383078
HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer
A Phase 2 study testing HR070803, Oxaliplatin and Tegafur in people with Efficacy and Safety, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- HR070803, Oxaliplatin and Tegafur
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 30 Dec 2027
- Phase
- Phase 2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
- ECOG performance status 0 or 1.
- 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.
- The number of lymph nodes dissected during resection ≥ 15.
- 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.
- CA19-9 exceeding normal value within 14 days prior to enrollment.
- 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.
About this study
Official title: HR070803 in Combination With Oxaliplatin Plus Tegafur Versus HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate as Adjuvant Therapy for Pancreatic Cancer: A Multicenter, Multi-cohort, Randomized, Phase II Study
The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) 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 1-year disease-free survival rate. 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 the Disease-free survival.
Tolerance Patients evaluable for toxicity must have received one investigational drug.
- Conditions
- Efficacy and Safety
- Being tested
- HR070803, Oxaliplatin, Tegafur, Folinic acid, 5-Fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR070803Drug
Also called Irinotecan Liposome
HR070803 60 mg/^2 D1 over 90 minutes.
OxaliplatinDrug
Also called L-OHP
Oxaliplatin 85 mg/^2 D1 over 2 hours.
TegafurDrug
Also called S-1
initial dose of S-1 is determined according to the body surface area，orally, D1-7.
Folinic acidDrug
Also called LV
Folinic acid 400 mg/^2 D1
5-FluorouracilDrug
Also called 5-FU
5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours
| Study group | Role | What they receive |
|---|---|---|
| HR070803+Oxaliplatin+S-1 | Experimental | Drug: HR070803（Irinotecan Liposome）; Oxaliplatin; Tegafur HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area，orally, D1-7.
These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles. Receives: Drug: HR070803; Drug: Oxaliplatin; Drug: Tegafur |
| HR070803+Oxaliplatin+5-FU/LV | Active comparator | Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Folinic acid 400 mg/^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours.
These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles. Receives: Drug: HR070803; Drug: Oxaliplatin; Drug: Folinic acid; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Disease-free survival rate
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: Up to 2 years
Secondary outcomes (2)
Overall survival (OS)
OS is defined as the time from date of randomization until the date of death from any cause.
Measured: Up to 2 years
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: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and SafetyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383078
- Sponsor's protocol ID
- MA-PC-II-012
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HR070803 in Combination With Oxaliplatin Plus Tegafur Versus HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate as Adjuvant Therapy for Pancreatic Cancer: A Multicenter, Multi-cohort, Randomized, Phase II Study
- ClinicalTrials.gov ID
- NCT06383078
- Acronym / sponsor ID
- MA-PC-II-012
- Conditions
- Efficacy and Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Apr 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 evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer.
Detailed description
STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the 1-year disease-free survival rate. 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 the Disease-free survival.
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+S-1 | Experimental | Drug: HR070803, Drug: Oxaliplatin, Drug: TegafurDrug: HR070803（Irinotecan Liposome）; Oxaliplatin; Tegafur HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area，orally, D1-7. These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles. |
| HR070803+Oxaliplatin+5-FU/LV | Active comparator | Drug: HR070803, Drug: Oxaliplatin, Drug: Folinic acid, Drug: 5-FluorouracilDrug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg/^2 D1 over 90 minutes. Oxaliplatin 85 mg/^2 D1 over 2 hours. Folinic acid 400 mg/^2 D1, IV infusion over 1 hours. 5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours. These drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
- ECOG performance status 0 or 1.
- 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.
- The number of lymph nodes dissected during resection ≥ 15.
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.
- CA19-9 exceeding normal value within 14 days prior to enrollment.
- 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 |
|---|---|---|
| HR070803Also: Irinotecan LiposomeHR070803 60 mg/^2 D1 over 90 minutes. | Drug | HR070803+Oxaliplatin+5-FU/LV, HR070803+Oxaliplatin+S-1 |
| OxaliplatinAlso: L-OHPOxaliplatin 85 mg/^2 D1 over 2 hours. | Drug | HR070803+Oxaliplatin+5-FU/LV, HR070803+Oxaliplatin+S-1 |
| TegafurAlso: S-1initial dose of S-1 is determined according to the body surface area，orally, D1-7. | Drug | HR070803+Oxaliplatin+S-1 |
| Folinic acidAlso: LVFolinic acid 400 mg/^2 D1 | Drug | HR070803+Oxaliplatin+5-FU/LV |
| 5-FluorouracilAlso: 5-FU5-FU 2400 mg/^2 D1 IV continuous infusion over 46 hours | Drug | HR070803+Oxaliplatin+5-FU/LV |
Primary outcome
1-year Disease-free survival rate
Time frame: Up to 2 years
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.
2 secondary outcomes
Overall survival (OS)
Time frame: Up to 2 years
Disease-free survival（DFS）
Time frame: Up to 2 years
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 25 Apr 2024.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HR070803, Oxaliplatin and Tegafur in people with Efficacy and Safety, run by The First Affiliated Hospital with Nanjing Medical University.
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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Disease-free survival rate (time frame: Up to 2 years). 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 25 Apr 2024.