NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer
NCT ID: NCT06494514
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-04-01
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NALIRINOX combined with PD-1 synchronous sequential SBRT
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.
nal-IRI+Oxaliplatin+5-FU/LV+PD-1
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-1
These drugs are given on d1, d8, 21 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.
AG combined with PD-1 synchronous sequential SBRT
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.
nal-IRI+Oxaliplatin+5-FU/LV+PD-1
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-1
These drugs are given on d1, d8, 21 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.
Interventions
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nal-IRI+Oxaliplatin+5-FU/LV+PD-1
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-1
These drugs are given on d1, d8, 21 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance no more than 2;
3. Radiographically assessed as locally advanced pancreatic cancer according to NCCN guidelines;
4. No previous anti-tumor therapy；
5. Able and willing to provide a written informed consent;
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Du Juan
OTHER
Responsible Party
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Du Juan
chief physician choice
Principal Investigators
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Juan Du
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Min Tu
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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FirstNanjingMU
Nanjing, Jiangsu, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Min Tu
Role: primary
Other Identifiers
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CSPC-DEY-PC-JS02
Identifier Type: -
Identifier Source: org_study_id
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