RecruitingPhase 2NCT06405490

NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC

Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

30 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new first-line combination treatment for advanced pancreatic cancer (pancreatic ductal adenocarcinoma, PDAC) that has spread locally or to other organs. The combination includes nanoliposomal irinotecan plus oxaliplatin and capecitabine (NALIRI-XELOX) together with an immunotherapy drug called AK104. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC) that is locally advanced or metastatic - You have not received any prior systemic treatment for this cancer - Your cancer has at least one measurable lesion - Your general health score (ECOG) is 0 or 1 - Your life expectancy is at least 3 months - Your organ function is adequate and you are not pregnant (with a negative test if applicable) **You may NOT be eligible if...** - You have untreated cancer in the brain or spinal cord covering (leptomeningeal metastasis) - You are currently on another clinical trial drug or have been recently - You have had major surgery within 4 weeks - You have received other anti-cancer treatment within 4 weeks 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

DRUGNanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab

Use the above medications on a regular basis


Locations(1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06405490


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