Pancreatic CancerPhase 3NCT06571461
Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
A Phase 3 study testing Liposomal Irinotecan, Oxaliplatin and S-1 in people with Pancreatic Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd..
Trial summary
This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery. 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?
- Liposomal Irinotecan, Oxaliplatin and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Mar 2029
- 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
- Patients able and willing to provide a written informed consent aged 18-75 years.
- Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).
- Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).
- Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- The main organs function well.
Who cannot join
- Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.
- Macroscopic incomplete tumor removal (R2 resection).
- Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
- Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.
- CA 19-9> 180 U / ml within 21 days before randomization.
- The toxicity of previous therapy has not recovered to Grade 1 or below.
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- Known peripheral neuropathy (CTCAE ≥ Grade 2).
- Known deficiency of dihydropyrimidine dehydrogenase (DPD)
- Subjects with a confirmed diagnosis of Gilbert's syndrome
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer
This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.
- Conditions
- Pancreatic Cancer
- Being tested
- Liposomal Irinotecan, Oxaliplatin, S-1, 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.
Liposomal IrinotecanDrug
Liposomal Irinotecan：i.v. infusion
OxaliplatinDrug
Oxaliplatin;：i.v. infusion
S-1Drug
S-1: Oral
GemcitabineDrug
Gemcitabine: i.v. infusion
CapecitabineDrug
Capecitabine: Oral
| Study group | Role | What they receive |
|---|---|---|
| NASOX：Liposomal Irinotecan; Oxaliplatin; S-1 | Experimental | Liposomal irinotecan at a dose of 50 mg/m² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg/m² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles. Receives: Drug: Liposomal Irinotecan; Drug: Oxaliplatin; Drug: S-1 |
| GX：Gemcitabine; Capecitabine | Active comparator | Gemcitabine at a dose of 1000mg/m² is administered via intravenous infusion over 30 minutes on D1, 8, and 15 of a 28-day cycle. Capecitabine at a dose of 1660mg/m² per day in two divided oral doses is taken for 21 consecutive days, followed by a 7-day rest period. These medications are administered once every 4 weeks for a total of 6 cycles. Receives: Drug: Gemcitabine; Drug: 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 the date of randomization to the date of disease recurrence or death from any cause (whichever occurs first). Disease recurrence is defined as evidence of disease recurrence demonstrated by imaging assessment with CT or MRI scan and/or pathological diagnosis indicated by biopsy.
Measured: Approximately 3 years.
Secondary outcomes (1)
Overall survival (OS)
Measured: Approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2029 (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 CSPC Ouyi Pharmaceutical 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
- This study is designed as a phase III, two-arm, open-label, multi-center, randomized clinical trial comparing combination liposomal irinotecan, oxaliplatin and S-1 with gemcitabine + capecitabine when used as adjuvant therapy following resection for pancreatic ductal adenocarcinoma.
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571461
- Sponsor's protocol ID
- HE072-006
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06571461
- Acronym / sponsor ID
- HE072-006
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 26 Aug 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.
This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed as a phase III, two-arm, open-label, multi-center, randomized clinical trial comparing combination liposomal irinotecan, oxaliplatin and S-1 with gemcitabine + capecitabine when used as adjuvant therapy following resection for pancreatic ductal adenocarcinoma.
| Arm | Type | Receives |
|---|---|---|
| NASOX：Liposomal Irinotecan; Oxaliplatin; S-1 | Experimental | Drug: Liposomal Irinotecan, Drug: Oxaliplatin, Drug: S-1Liposomal irinotecan at a dose of 50 mg/m² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg/m² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles. |
| GX：Gemcitabine; Capecitabine | Active comparator | Drug: Gemcitabine, Drug: CapecitabineGemcitabine at a dose of 1000mg/m² is administered via intravenous infusion over 30 minutes on D1, 8, and 15 of a 28-day cycle. Capecitabine at a dose of 1660mg/m² per day in two divided oral doses is taken for 21 consecutive days, followed by a 7-day rest period. These medications are administered once every 4 weeks for a total of 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients able and willing to provide a written informed consent aged 18-75 years.
- Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).
- Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).
- Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (9 listed)
- Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.
- Macroscopic incomplete tumor removal (R2 resection).
- Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
- Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.
- CA 19-9> 180 U / ml within 21 days before randomization.
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 |
|---|---|---|
| Liposomal IrinotecanLiposomal Irinotecan：i.v. infusion | Drug | NASOX：Liposomal Irinotecan; Oxaliplatin; S-1 |
| OxaliplatinOxaliplatin;：i.v. infusion | Drug | NASOX：Liposomal Irinotecan; Oxaliplatin; S-1 |
| S-1S-1: Oral | Drug | NASOX：Liposomal Irinotecan; Oxaliplatin; S-1 |
| GemcitabineGemcitabine: i.v. infusion | Drug | GX：Gemcitabine; Capecitabine |
| CapecitabineCapecitabine: Oral | Drug | GX：Gemcitabine; Capecitabine |
Primary outcome
Disease-free survival (DFS)
Time frame: Approximately 3 years.
Disease-free survival is defined as the time from the date of randomization to the date of disease recurrence or death from any cause (whichever occurs first). Disease recurrence is defined as evidence of disease recurrence demonstrated by imaging assessment with CT or MRI scan and/or pathological diagnosis indicated by biopsy.
1 secondary outcome
Overall survival (OS)
Time frame: Approximately 5 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 27 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal Irinotecan, Oxaliplatin and S-1 in people with Pancreatic Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd..
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 9 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 27 Aug 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 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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), 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: Approximately 3 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 27 Aug 2024.