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

Phase 2Not Yet RecruitingNCT06669078

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Locally Advanced Pancreatic Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

1 year OS rate

Proportion of patients alive from randomization to 1 year

Time frame: Up to 12 months]

Secondary Outcomes

R0/R1 rate

Percentage of patients who achieved R0/RI resection

Time frame: Up to 6 months

The rate of mPR

Proportion of patients who achieved mPR by post-operative specimen testing

Time frame: Up to 6 months

Time from randomization to death

Time frame: 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.

Time frame: Up to 6 months

PFS

Time from randomization to disease progression and/or death.

Time frame: Up to 12 months

Surgical resection rate

Operable rate

Time frame: 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).

Central Contacts

Qiu Yudong M.D., Ph.D

CONTACT

+86-025-83106666 yudongqiu510@163.com

Data from ClinicalTrials.gov

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