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AG Followed by FOLFIRINOX Both Combined With PD-L1 Antibodies as a Conversion Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer.

NCT07208539 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-10-06

No results posted yet for this study

Summary

The goal of this interventional study is to learn about the clinical efficacy of sequential therapy (albumin paclitaxel, gemcitabine combined with PD-L1 antibodies, followed by liposomal irinotecan, oxaliplatin and 5-FU/LV combined with PD-L1 antibodies). The main questions it aims to answer are:

Does the sequential therapy increase the resection rate of borderline resectable / locally advanced pancreatic cancer? Does the sequential therapy represent an effective and safe treatment? Participants will receive two distinct chemotherapy regimens, each combined with a PD-L1 antibody, administered in sequence for two cycles each.

Conditions

Interventions

DRUG

Treatment: AG & anti-PD-L1 + FOLFIRINOX & anti-PD-L1

The cohort A (borderline resectable) and cohort B (locally advanced) both received treatment with gemcitabine, albumin paclitaxel (administered on days 1, 8, and 15, with 4 weeks as one cycle) and adalimumab (administered once every 4 weeks, with 4 weeks as one cycle). After completing 2 cycles of treatment, they were sequentially given liposomal irinotecan combined with 5-FU/LV, oxaliplatin (administered once every 2 weeks, with 4 weeks as one cycle) and adalimumab (administered once every 4 weeks, with 4 weeks as one cycle). After completing 2 cycles of sequential treatment, surgical evaluation was conducted: for patients who could undergo radical surgical resection, surgery was performed within 2-4 weeks after the end of the conversion treatment stage, and the postoperative treatment plan was selected based on the investigator's judgment; for patients who could not undergo radical surgical resection, subsequent treatment plans could be selected based on the investigator's judgment.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2026-04-09
Completion
2026-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07208539 on ClinicalTrials.gov