Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to explore the effectiveness and safety of a treatment called chemoradiotherapy in older adults, aged 70 to 85, who have locally advanced pancreatic cancer that cannot be removed with surgery. The goal is to find out if this treatment can help these patients without the need for major surgery. Participants will first receive chemotherapy, then have a combination of chemotherapy and radiation therapy, followed by maintenance therapy to keep the cancer under control.

To be eligible for this trial, participants must be between 70 and 85 years old, have a life expectancy of more than one year, and must have a specific type of pancreatic cancer confirmed by a doctor. They should not have had any prior cancer treatments and should be in decent health, meaning they should be able to perform daily activities with little assistance. This trial is currently not recruiting participants, but it aims to provide valuable information about how older patients can be treated for pancreatic cancer safely and effectively. If you or a loved one are considering participation, it's important to discuss this with your healthcare provider to understand all the details and determine if it's a suitable option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntarily participate and sign the informed consent form
• • Age 70-85 years old, life expectancy \> 1 year and gender is not limited
• • Eastern Cooperative Oncology Group Physical Status Score (ECOG) physical state score\<=1 point
• • Pathological or cytological confirmation of pancreatic ductal adenocarcinoma (including IPMN malignant transformation, acinar carcinoma, etc., excluding adenosquamous cell carcinoma and neuroendocrine carcinoma)
• • The clinical stage is stage III (locally advanced pancreatic cancer), and no radical surgery has been performed (bypass surgery is acceptable), or the patient has resectable pancreatic cancer, but cannot accept surgery or refuse surgery due to physical strength or concomitant diseases
• • Have not received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
• • No serious hematological, cardiological, pulmonary function abnormalities and autoimmune deficiencies (refer to their respective diagnostic criteria)
• • Blood routine index: white blood cell (WBC) \>=3.0 × 109/L; Absolute neutrophil count (ANC) \>=1.5 × 109/L; Platelets (PLT) \>=100 × 109/L; hemoglobin (Hgb) \>=90 g/L
• • Blood biochemical indexes: AST (SGOT), ALT (SGPT) \<=2.5 × upper limit of normal value (ULN); Total bilirubin (TBIL) \< = ULN; Serum creatinine (CRE) \<=1.5 × ULN
• • Coagulation function: prothrombin time (PT), international normalized ratio (INR) \<=1.5 × ULN
• • Able to comply with the requirements of the study visit plan and other programs.
• Exclusion Criteria:
• • Accompanied by malignant tumors of other systems
• • Received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
• • Have used any other non-anti-tumor research drugs within 4 weeks before treatment
• • Combined with uncontrollable hypertension, diabetes, infection, etc.
• • Poor compliance, unable or unwilling to sign informed consent
• • Patients who are expected to be out of the observation period for 14 days or more during the treatment period.