Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).
NCT ID: NCT06844773
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
36 participants
OBSERVATIONAL
2025-02-28
2028-02-29
Brief Summary
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Does chemoradiotherapy represent an effective and safe treatment for older participants without radical surgery? Participants will sequentially receive combined chemotherapy followed by concurrent chemoradiotherapy and subsequent maintenance therapy.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observation group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
70 Years
85 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Locations
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Zhongshan Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZSPAC-08
Identifier Type: -
Identifier Source: org_study_id
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