Locally Advanced Pancreatic Cancer
Conditions
Keywords
NALIRIFOX, Conversion Therapy, Locally Advanced Pancreatic Cancer
Brief 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
Interventions
DRUGNal-lRl+Oxaliplain+5- FU +PD 1
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.
DRUGNal-lRl+Oxaliplain+5- FU
Nal-lRl+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confi rmed pancreatic cancer; 2. ECOG performance no more than 1; 3. Radiographically assessed as locally advanced pancreatic cancer according ; 4. No previous anti-tumor therapy; 5. Able and willing to provide a written informed consent.
Exclusion criteria
1. Prior anti-tumor therapy of any kind; 2. Known to be symptomatic central nervous system metastasis and/or cancerous meningitis. 3. Patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive drugs; 4. Patients with bleeding tendency; 5. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 year OS rate | Up to 12 months] | Proportion of patients alive from randomization to 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of mPR | Up to 6 months | Proportion of patients who achieved mPR by post-operative specimen testing |
| OS | Up to 24 months | Time from randomization to death |
| ORR | Up to 6 months | According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) after treatment and maintained the minimum time-frame requirement. |
| R0/R1 rate | Up to 6 months | Percentage of patients who achieved R0/RI resection |
| Surgical resection rate | Up to 6 months | Operable rate |
| The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety] | From the first treatment to 28 days after the last treatment, about 6 months | 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). |
| PFS | Up to 12 months | Time from randomization to disease progression and/or death. |
Contacts
Primary ContactQiu Yudong M.D., Ph.D
Outcome results
None listed