Locally Advanced Pancreatic CancerPhase 2NALIRIFOXNCT06669078
NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy of Locally Advanced Pancreatic Cancer
A Phase 2 study testing Nal-lRl+Oxaliplain+5- FU +PD 1 and Nal-lRl+Oxaliplain+5- FU in people with Locally Advanced Pancreatic Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The purpose of the prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Nal-lRl+Oxaliplain+5- FU +PD 1 and Nal-lRl+Oxaliplain+5- FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 15 Oct 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confi rmed pancreatic cancer;
- ECOG performance no more than 1;
- Radiographically assessed as locally advanced pancreatic cancer according ;
- No previous anti-tumor therapy;
- Able and willing to provide a written informed consent.
Who cannot join
- Prior anti-tumor therapy of any kind;
- Known to be symptomatic central nervous system metastasis and/or cancerous meningitis.
- Patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive drugs;
- Patients with bleeding tendency;
- Pregnant or lactating women.
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 Prospective, Open, Randomized Controlled, Multicenter, Exploratory Clinical Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer
The purpose of the prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- Nal-lRl+Oxaliplain+5- FU +PD 1, Nal-lRl+Oxaliplain+5- FU
- Keywords
- NALIRIFOX, Conversion Therapy, Locally Advanced Pancreatic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nal-lRl+Oxaliplain+5- FU +PD 1Drug
Nal-lRl+Oxaliplatin+5- FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, SBRT is performed during the third and fourth cycle.
Nal-lRl+Oxaliplain+5- FUDrug
Nal-lRl+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.
| Study group | Role | What they receive |
|---|---|---|
| NALIRINOX combined with PD-1 synchronous sequential SBRT group | Experimental | Nal-IRI+Oxaliplatin+5- FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, SBRT is performed during the third and fourth cycle. Receives: Drug: Nal-lRl+Oxaliplain+5- FU +PD 1 |
| NALIRIFOX group | Experimental | Nal-IRI+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle. Receives: Drug: Nal-lRl+Oxaliplain+5- FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year OS rate
Proportion of patients alive from randomization to 1 year
Measured: Up to 12 months]
Secondary outcomes (7)
R0/R1 rate
Percentage of patients who achieved R0/RI resection
Measured: Up to 6 months
The rate of mPR
Proportion of patients who achieved mPR by post-operative specimen testing
Measured: Up to 6 months
OS
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 6 months
PFS
Time from randomization to disease progression and/or death.
Measured: Up to 12 months
Surgical resection rate
Operable rate
Measured: Up to 6 months
The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety]
Using the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, we analyzed the data of all subjects who received at least one study treatment. We collected and summarized the overall incidence of adverse events (AE), the incidence of grade 3 or higher AE, and the incidence of serious adverse events (SAE).
Measured: From the first treatment to 28 days after the last treatment, about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start30 Oct 2024 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 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.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- NCT06669078
- Sponsor's protocol ID
- CSPC-DEY-PC-JS06
- Acronym
- NALIRIFOX
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Randomized Controlled, Multicenter, Exploratory Clinical Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06669078
- Acronym / sponsor ID
- NALIRIFOX / CSPC-DEY-PC-JS06
- Conditions
- Locally Advanced Pancreatic Cancer
- Keywords
- NALIRIFOX, Conversion Therapy, Locally Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 1 Nov 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 prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally 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 group | Experimental | Drug: Nal-lRl+Oxaliplain+5- FU +PD 1Nal-IRI+Oxaliplatin+5- FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, SBRT is performed during the third and fourth cycle. |
| NALIRIFOX group | Experimental | Drug: Nal-lRl+Oxaliplain+5- FUNal-IRI+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confi rmed pancreatic cancer;
- ECOG performance no more than 1;
- Radiographically assessed as locally advanced pancreatic cancer according ;
- No previous anti-tumor therapy;
- Able and willing to provide a written informed consent.
Key exclusion criteria (5 listed)
- Prior anti-tumor therapy of any kind;
- Known to be symptomatic central nervous system metastasis and/or cancerous meningitis.
- Patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive drugs;
- Patients with bleeding tendency;
- 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-lRl+Oxaliplain+5- FU +PD 1Nal-lRl+Oxaliplatin+5- FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, SBRT is performed during the third and fourth cycle. | Drug | NALIRINOX combined with PD-1 synchronous sequential SBRT group |
| Nal-lRl+Oxaliplain+5- FUNal-lRl+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle. | Drug | NALIRIFOX group |
Primary outcome
1 year OS rate
Time frame: Up to 12 months]
Proportion of patients alive from randomization to 1 year
7 secondary outcomes
R0/R1 rate
Time frame: Up to 6 months
The rate of mPR
Time frame: Up to 6 months
OS
Time frame: Up to 24 months
ORR
Time frame: Up to 6 months
PFS
Time frame: Up to 12 months
Surgical resection rate
Time frame: Up to 6 months
The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety]
Time frame: From the first treatment to 28 days after the last treatment, about 6 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 1 Nov 2024.
- Individual participant dataSharing planned: No
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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 2 study testing Nal-lRl+Oxaliplain+5- FU +PD 1 and Nal-lRl+Oxaliplain+5- FU in people with Locally Advanced Pancreatic Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 5 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 1 Nov 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?
Contact Qiu Yudong M.D., Ph.D (+86-025-83106666, yudongqiu510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year OS rate (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 1 Nov 2024.