RecruitingPhase 2NCT06584227

Adebrelimab and Chidamide for Pancreatic Cancer

A Single-Arm, Multicenter, Open, Phase II Clinical Study of Adebrelimab and Chidamide in Combination With Gemcitabine and S1 for the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer

Sponsor

Liu Xiufeng

Enrollment

45 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer, Adult

Summary

Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. The primary treatment regimen for advanced pancreatic cancer remains chemotherapy, which results in a median survival time of only 8 to 12 months. Therefore, there is an urgent need to explore new combination therapies to extend survival. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — adebrelimab (an immunotherapy) and chidamide (a targeted drug) — in people with advanced pancreatic cancer that cannot be surgically removed and has not yet been treated with systemic (whole-body) therapy. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced or metastatic pancreatic cancer (stage III or IV) - You have not previously received any systemic cancer treatment for this cancer - You have at least one measurable tumor on imaging - Your overall health is rated acceptable on standard performance scales **You may NOT be eligible if...** - You have previously received chemotherapy or immunotherapy for this cancer - You have uncontrolled infections, autoimmune diseases, or severe organ dysfunction - You are pregnant or breastfeeding - You have active brain metastases - You have serious heart conditions 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

DRUGAdebrelimab and Chidamide Combined with Gemcitabine and S1

Chidamide：20mg，po，biw，（d8、11、15、18）； Adebrelimab: 1200mg，d8，q3w； Gemcitabine：800-1000mg/m2，bid，d1、d8，q3w； S1：40mg/50mg，bid，d1-14，q3w.

Locations(1)

Jinling Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06584227

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