RecruitingPhase 2NCT06404840

Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases : A Prospective, Single-Arm, Phase II Study

Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases (PCLM): A Prospective, Single-Arm, Phase II Study


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

30 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with PCLM account for the majority of our department's pancreatic cancer cases and often have limited surgical options due to the aggressive nature of their tumors. For those with good performance status (ECOG PS 0-1), NCCN recommends gemcitabine + nab-paclitaxel (AG). Though nimotuzumab combined with gemcitabine improves survival, there remains scarce clinical data regarding its efficacy in conjunction with AG for treating PCLM. This study aims to evaluate the safety and efficacy of incorporating nimotuzumab with AG for PCLM.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding the targeted antibody drug nimotuzumab to a standard chemotherapy regimen (gemcitabine plus albumin-bound paclitaxel, called AG) improves outcomes in patients with pancreatic cancer that has spread to the liver. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) with liver metastases, confirmed by biopsy or cytology - Your cancer is not suitable for surgery or radical radiation - You have at least one measurable lesion on imaging - Your general health score (KPS) is 60 or above - Your expected survival is more than 3 months - Your blood counts and organ function (liver, kidneys) are within acceptable ranges **You may NOT be eligible if...** - You have already received palliative chemotherapy or targeted therapy for pancreatic cancer - You have cancer that has spread to the brain - You have had major surgery within 4 weeks - You are currently participating in another clinical trial - You are pregnant or not using contraception if childbearing is possible 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

DRUGnimotuzumab

nimotuzumab (400 mg, iv, d1, qw)

DRUGAG chemotherapy

(gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle)


Locations(1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

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NCT06404840


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