NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy as First-line Treatment of Locally Advanced Pancreatic Cancer

NCT06494514 | Recruiting

• 1 other identifier: CSPC-DEY-PC-JS02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer.

Conditions

Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• mPFS

  Time from randomization to disease progression and/or death.

  Up to 12 months

Secondary Outcomes (3)

• mOS

  Up to 24 months

• ORR

  Up to 12 months

• DCR

  Up to 12 months

Study Arms (2)

NALIRINOX combined with PD-1 synchronous sequential SBRT

EXPERIMENTAL

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.

Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1; Drug: Gemcitabine + albumin-paclitaxel+PD-1

AG combined with PD-1 synchronous sequential SBRT

EXPERIMENTAL

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.

Drug: nal-IRI+Oxaliplatin+5-FU/LV+PD-1; Drug: Gemcitabine + albumin-paclitaxel+PD-1

Interventions

nal-IRI+Oxaliplatin+5-FU/LV+PD-1 DRUG

These drugs are given on d1, d15, 28 days as one cycle. 6-6 treatment cycles. SBRT is performed in third cycles.

AG combined with PD-1 synchronous sequential SBRT; NALIRINOX combined with PD-1 synchronous sequential SBRT

Gemcitabine + albumin-paclitaxel+PD-1 DRUG

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; NALIRINOX combined with PD-1 synchronous sequential SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed pancreatic cancer;
• ECOG performance no more than 2;
• Radiographically assessed as locally advanced pancreatic cancer according to NCCN guidelines;
• No previous anti-tumor therapy；
• Able and willing to provide a written informed consent;

You may not qualify if:

• \. Prior anti-tumor therapy of any kind; 2. Severe infection (\>NCI CTC grade 2); 3.Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs; 4.Patients with bleeding tendency; 5. Pregnant or lactating women.

Sponsors & Collaborators

• Du Juan: lead

Study Sites (2)

FirstNanjingMU

Nanjing, Jiangsu, 025, China

NOT YET RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 025, China

RECRUITING

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Juan Du

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

• Min Tu

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Juan Du, M.D. Ph.D

CONTACT

+86-025-83106666; dujunglyy@163.com

Juan Du

CONTACT

02583106666; dujunglyy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician choice

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

CN (2)