NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy of Locally Advanced Pancreatic Cancer

Phase 2

Not yet recruiting

• Conditions: Locally Advanced Pancreatic Cancer
• Interventions: Drug: Nal-lRl+Oxaliplain+5- FU; Drug: Nal-lRl+Oxaliplain+5- FU +PD 1

• Registration Number: NCT06669078
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-27
• Study Start: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Primary Completion: 2027-10-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NALIRIFOX group	Nal-lRl+Oxaliplain+5- FU	Nal-IRI+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.
NALIRINOX combined with PD-1 synchronous sequential SBRT group	Nal-lRl+Oxaliplain+5- FU +PD 1	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.

Primary Outcome Measures

Name	Time	Method
1 year OS rate	Up to 12 months]	Proportion of patients alive from randomization to 1 year

Secondary Outcome Measures

Name	Time	Method
R0/R1 rate	Up to 6 months	Percentage of patients who achieved R0/RI resection
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.
PFS	Up to 12 months	Time from randomization to disease progression and/or death.
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).