Pancreatic CancerNCT06361316
Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer
A study testing Irinotecan liposome injection in people with Pancreatic Cancer and Adjuvant Therapy, run by Kuirong Jiang at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Adjuvant Therapy
- What is being tested?
- Irinotecan liposome injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2024to 31 Jul 2028
- Phase
- Interventional
- 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).
- ECOG performance status 0 or 1.
- Life expectancy of greater than or equal to 6 months.
- Able and willing to provide a written informed consent.
Who cannot join
- Patients who cannot eat orally and have gastric emptying disorder after surgery;
- Patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; Or diarrhea that limits activities of daily living;
- Patients who cannot eat orally and have gastric emptying disorder after surgery;
- Patients who cannot eat orally and have gastric emptying disorder after surgery;
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, 1 recruiting
- Recruiting
FirstNanjingMU
Nanjing, Jiangsu, 025
KuiRong Jiang, archiater, 15312995688, Jiangkuirong@163.com
Min Tu, associate doctor
About this study
Official title: Efficacy and Safety of Irinotecan Liposome Injection Combined With Oxaliplatin and Tegafur (NASOX) in Adjuvant Chemotherapy for Pancreatic Cancer
The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer.
- Conditions
- Pancreatic Cancer, Adjuvant Therapy
- Being tested
- Irinotecan liposome injection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposome injectionDrug
Also called oxaliplatin, Tegafur
Postoperative adjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposome injection+ Oxaliplatin +Tegafur | Experimental | Oxaliplatin: 60mg/m2, d1, ivgtt, 2h; Repeat every 15 days; Irinotecan liposomes: 50mg/m2, d1, ivgtt, 90min; Repeat every 15 days; Tegafur: 40-60mg, BID, po, d1-d10, repeat every 15 days; 30 days as one cycle, 6 treatment cycles. Receives: Drug: Irinotecan liposome injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival, DFS
the time from the start of randomization (or the start of treatment in a one-arm trial) to the recurrence of disease or death from any cause, whichever occurs first.
Measured: baseline up to approximately 21.6 months.
Secondary outcomes (5)
Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE
Hematologic and non-hematologic adverse events during adjuvant therapy (according to NCI-CTCAE5.0);
Measured: baseline up to approximately 7 months.
Overall Survival, OS
the time from the start of randomization (or the start of treatment in a one-arm trial) to death from any cause.
Measured: baseline up to approximately55 months.
Quality of life, QOL
It reflects the ability of human activities to improve the survival level and survival chances, evaluated according to EORTC Quality of life measurement scale QLQ-C30 V3.0 assessment.
Measured: baseline up to approximately 55 months.
The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy
The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy
Measured: baseline up to approximately 7 months.
he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance
The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy and the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance
Measured: baseline up to approximately 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start8 Apr 2024 (estimated)
- Primary completion25 Mar 2025 (estimated)
- Study completion31 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuirong Jiang
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Kuirong Jiang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- KuiRong Jiang, archiater, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361316
- Sponsor's protocol ID
- CSPC-DEY-PC-JS01
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Irinotecan Liposome Injection Combined With Oxaliplatin and Tegafur (NASOX) in Adjuvant Chemotherapy for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06361316
- Acronym / sponsor ID
- CSPC-DEY-PC-JS01
- Conditions
- Pancreatic Cancer, Adjuvant Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Kuirong JiangUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 8 Apr 2024 (estimated)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 11 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 irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposome injection+ Oxaliplatin +Tegafur | Experimental | Drug: Irinotecan liposome injectionOxaliplatin: 60mg/m2, d1, ivgtt, 2h; Repeat every 15 days; Irinotecan liposomes: 50mg/m2, d1, ivgtt, 90min; Repeat every 15 days; Tegafur: 40-60mg, BID, po, d1-d10, repeat every 15 days; 30 days as one cycle, 6 treatment cycles. |
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.
- 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.
- Able and willing to provide a written informed consent.
Key exclusion criteria (4 listed)
- Patients who cannot eat orally and have gastric emptying disorder after surgery;
- Patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; Or diarrhea that limits activities of daily living;
- Patients who cannot eat orally and have gastric emptying disorder after surgery;
- Patients who cannot eat orally and have gastric emptying disorder after surgery;
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 |
|---|---|---|
| Irinotecan liposome injectionAlso: oxaliplatin, TegafurPostoperative adjuvant therapy | Drug | Irinotecan liposome injection+ Oxaliplatin +Tegafur |
Primary outcome
Disease Free Survival, DFS
Time frame: baseline up to approximately 21.6 months.
the time from the start of randomization (or the start of treatment in a one-arm trial) to the recurrence of disease or death from any cause, whichever occurs first.
5 secondary outcomes
Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE
Time frame: baseline up to approximately 7 months.
Overall Survival, OS
Time frame: baseline up to approximately55 months.
Quality of life, QOL
Time frame: baseline up to approximately 55 months.
The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy
Time frame: baseline up to approximately 7 months.
he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance
Time frame: baseline up to approximately 7 months.
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 11 Apr 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.
KuiRong Jiang, archiater principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irinotecan liposome injection in people with Pancreatic Cancer and Adjuvant Therapy, run by Kuirong Jiang 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: looking for participants now, as of the sponsor's last update on 11 Apr 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.
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 KuiRong Jiang, archiater (15312995688, Jiangkuirong@163.com), 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: baseline up to approximately 21.6 months.). 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 11 Apr 2024.