RecruitingNot ApplicableNCT06840067

Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.

Single-arm Clinical Study of Carbon Ion Radiotherapy Combined with Nituzumab and Gemcitabine for Pancreatic Cancer.


Sponsor

Gansu Wuwei Tumor Hospital

Enrollment

62 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective is to evaluate the efficacy and safety of carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing carbon ion radiotherapy (a precise, high-energy form of radiation) combined with chemotherapy (gemcitabine plus a targeted antibody) for people with locally advanced or metastatic pancreatic cancer. Carbon ion therapy delivers radiation more precisely than standard X-ray radiation, potentially killing more cancer cells with less damage to surrounding tissue. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with locally advanced or metastatic pancreatic adenocarcinoma (stage III or IV) confirmed by lab tests - You have at least one measurable tumor on scans - Your liver, kidney, and blood counts are within acceptable limits **You may NOT be eligible if...** - You have had another cancer (except cured skin cancer or early-stage cervical cancer) - Your organ function is too impaired - You are pregnant or breastfeeding - You have other serious medical conditions that would make treatment unsafe 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

RADIATIONcarbon ion radiotherapy (CIRT)

1.CIRT: GTV: Primary tumor visible on imaging and clinical examination, and involved regional lymph nodes identified by CT/MRI (≥1.0 cm) or PET/CT scan. CTV: GTV plus 5mm margin, include posterior peritoneal plexus area and elective node irradiation around the pancreas (ENI). PTV: CTV plus 2.5-5mm margin (depending on the system error of each unit; When pancreatic head cancer is close to the stomach and intestines, the gastrointestinal direction does not expand). ITV: delineated on 4D-CT considering the influence of respiratory activity. Prescription dose: Stratification by measuring the nearest distance between PTV and gastrointestinal tract (≥5mm or \< 5mm); Pancreatic head cancer (distance \< 5mm) : 52.8Gy(RBE)/4.4Gy/12Fx; Pancreatic head, body and tail cancer (≥5mm) : 57.2Gy(RBE)/4.4Gy/13Fx. CIRT was once a day, four or five times a week. 2.Chemotherapy:Gemcitabine 1000mg/m2, intravenous infusion, dl, d8; Q3w . 3.Targeted therapyNituzumab injection 400mg, Qw,at least 4-6 cycles.


Locations(1)

Heavy Ion Radiotherapy Department

Wuwei, Gansu, China

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NCT06840067


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