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NCT06844773Not yet recruiting

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

A Single-center, Prospective, Observational Cohort Study of Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).

Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this observational study is to learn about the therapeutic effects of chemoradiotherapy for older adults (age 70-85) with locally advanced pancreatic cancer. The main question it aims to answer is: 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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
36 (estimated)
First submitted
6 Feb 2025
Start date
Feb 2025
Primary completion date
Feb 2027
Lead sponsor
Shanghai Zhongshan Hospital
NCT number
NCT06844773

What you commit to

  • Study type: Observational
  • Planned participants: 36
  • From Feb 2025 to the primary completion date, Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Accompanied by malignant tumors of other systems
  • Combined with uncontrollable hypertension, diabetes, infection, etc.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 70 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.