RecruitingPhase 2NCT06359275

PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients

A Phase II Study on the Safety and Efficacy of PD-1 Combined With Nab-paclitaxel/Gemcitabine and PULSAR in the Treatment of Locally Advanced Unresectable Pancreatic Cancer and Local Recurrence After Surgery.


Sponsor

Fudan University

Enrollment

81 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a treatment combination for locally advanced pancreatic cancer — immune checkpoint therapy (anti-PD-1), chemotherapy, plus a special radiation approach called PULSAR (which delivers radiation in intermittent pulses rather than daily doses). The goal is to see if this combination can shrink tumors enough to allow surgery or improve survival. **You may be eligible if...** - You are 18 or older - You have locally advanced pancreatic cancer confirmed by biopsy or cytology, OR pancreatic cancer that has come back locally (not spread to distant organs) after surgery - You have at least one measurable lesion - You are in generally good physical condition (ECOG 0–1) - Your estimated survival is at least 3 months - You are willing to potentially undergo surgery after treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have previously received PD-1/PD-L1 immunotherapy - You have serious bleeding, active infection, or major organ failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-1

Toripalimab,240 mg/time,D1, Q3W

DRUGNab-paclitaxel

Nab-paclitaxel, 125mg/m2,IV,D1,8, Q3W

DRUGGemcitabine

Gemcitabine,1000mg/m2,IV,D1,8,Q3W

RADIATIONPULSAR

5-10 Gy per session, a total of 5 times.


Locations(1)

Fudan University Shanghai Cancer Center

Shanhai, China

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NCT06359275


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