Locally Advanced Pancreatic CancerNCT06494514
NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer
A study testing nal-IRI+Oxaliplatin+5-FU/LV+PD-1 and Gemcitabine + albumin-paclitaxel+PD-1 in people with Locally Advanced Pancreatic Cancer, run by Du Juan at 2 sites in China.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- nal-IRI+Oxaliplatin+5-FU/LV+PD-1 and Gemcitabine + albumin-paclitaxel+PD-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2024to 1 Apr 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed pancreatic cancer;
- ECOG performance no more than 2;
- Radiographically assessed as locally advanced pancreatic cancer according to NCCN guidelines;
- No previous anti-tumor therapy；
- Able and willing to provide a written informed consent;
Who cannot join
- 1. Prior anti-tumor therapy of any kind; 2. Severe infection (>NCI CTC grade 2); 3.Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs; 4.Patients with bleeding tendency; 5. Pregnant or lactating women.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
FirstNanjingMU
Nanjing, Jiangsu, 025
Min Tu, 13585181045 ext. 025
Min Tu, 13585181045 ext. 025, tumin1215@163.com
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 025
Juan Du, M.D. Ph.D, +86-025-83106666, dujunglyy@163.com
Min Tu
About this study
Official title: A Single-center, Randomized, Interventional Controlled Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy for First-line Treatment of Locally Advanced Pancreatic Cancer
The purpose of the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- nal-IRI+Oxaliplatin+5-FU/LV+PD-1, Gemcitabine + albumin-paclitaxel+PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nal-IRI+Oxaliplatin+5-FU/LV+PD-1Drug
These drugs are given on d1, d15, 28 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.
Gemcitabine + albumin-paclitaxel+PD-1Drug
These drugs are given on d1, d8, 21 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.
| Study group | Role | What they receive |
|---|---|---|
| NALIRINOX combined with PD-1 synchronous sequential SBRT | Experimental | Nal-IRI+Oxaliplatin+5-FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle. Receives: Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1; Drug: Gemcitabine + albumin-paclitaxel+PD-1 |
| AG combined with PD-1 synchronous sequential SBRT | Experimental | Gemcitabine + albumin-paclitaxel +PD-1, these drugs are given on d1, d8, 21 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle. Receives: Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1; Drug: Gemcitabine + albumin-paclitaxel+PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mPFS
Time from randomization to disease progression and/or death.
Measured: Up to 12 months
Secondary outcomes (3)
mOS
Time from randomization to death
Measured: Up to 24 months
ORR
According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) after treatment and maintained the minimum time-frame requirement.
Measured: Up to 12 months
DCR
According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) and stable lesion (SD) after treatment and maintained the minimum time-frame requirements.
Measured: 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 posted10 Jul 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Du Juan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Du Juan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Juan Du, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolMin Tu, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494514
- Sponsor's protocol ID
- CSPC-DEY-PC-JS02
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Interventional Controlled Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy for First-line Treatment of Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06494514
- Acronym / sponsor ID
- CSPC-DEY-PC-JS02
- Conditions
- Locally Advanced Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Du JuanUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 10 Jul 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 the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NALIRINOX combined with PD-1 synchronous sequential SBRT | Experimental | Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1, Drug: Gemcitabine + albumin-paclitaxel+PD-1Nal-IRI+Oxaliplatin+5-FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle. |
| AG combined with PD-1 synchronous sequential SBRT | Experimental | Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1, Drug: Gemcitabine + albumin-paclitaxel+PD-1Gemcitabine + albumin-paclitaxel +PD-1, these drugs are given on d1, d8, 21 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed pancreatic cancer;
- ECOG performance no more than 2;
- Radiographically assessed as locally advanced pancreatic cancer according to NCCN guidelines;
- No previous anti-tumor therapy；
- Able and willing to provide a written informed consent;
Key exclusion criteria (1 listed)
- 1. Prior anti-tumor therapy of any kind; 2. Severe infection (>NCI CTC grade 2); 3.Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs; 4.Patients with bleeding tendency; 5. Pregnant or lactating women.
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 |
|---|---|---|
| nal-IRI+Oxaliplatin+5-FU/LV+PD-1These drugs are given on d1, d15, 28 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles. | Drug | AG combined with PD-1 synchronous sequential SBRT, NALIRINOX combined with PD-1 synchronous sequential SBRT |
| Gemcitabine + albumin-paclitaxel+PD-1These drugs are given on d1, d8, 21 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles. | Drug | AG combined with PD-1 synchronous sequential SBRT, NALIRINOX combined with PD-1 synchronous sequential SBRT |
Primary outcome
mPFS
Time frame: Up to 12 months
Time from randomization to disease progression and/or death.
3 secondary outcomes
mOS
Time frame: Up to 24 months
ORR
Time frame: Up to 12 months
DCR
Time frame: Up to 12 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 10 Jul 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.
Juan Du principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Min Tu study director
The First Affiliated Hospital with Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nal-IRI+Oxaliplatin+5-FU/LV+PD-1 and Gemcitabine + albumin-paclitaxel+PD-1 in people with Locally Advanced Pancreatic Cancer, run by Du Juan at 2 sites 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 1 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Juan Du, M.D. Ph.D (+86-025-83106666, dujunglyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mPFS (time frame: Up to 12 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 10 Jul 2024.