Chemoradiotherapy In Elderly Patients With Locally Advanced Pancreatic Cancer (70+).

Study Overview

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

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.

N/A

Unresectable Locally Advanced Pancreatic Cancer

ZSPAC-08

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-02-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-19
First Submitted that Met QC Criteria 2025-02-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-25
First Posted (ACTUAL) 2025-02-25	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Observation group

Primary Outcome Measures	Measure Description	Time Frame
1-year survival rate	To observe whether the 1-year survival rate of elderly patients with locally advanced pancreatic cancer treated with sandwich-like chemoradiotherapy modality was comparable to that of the historical data of the general adult population.	From the date of first therapy administration to one year later

Secondary Outcome Measures	Measure Description	Time Frame
Toxicity and side effects and tolerability assessment	Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTCAE Version 5.0.	From the date of first therapy administration to within 90 days, up to 24 months
event-free survival throughout the enrolled subject population	Survival time from the start of therapy administration to the date of first documented progression or the date of death	From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
the proportion of participants that completed chemoradiotherapy		From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
the proportion ofparticipants that completed all planned courses		From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
Objective response rate (ORR) tumor target lesions in the entire subject population all planned courses	ORR is defined as the percentage of patients who achieve complete response (CR) or partial response (PR) based on the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.	From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Disease control rate (DCR) of tumor target lesions in the entire subject population all planned courses	DCR is defined as the percentage of patients who achieved CR, PR and stable disease (SD), and will be evaluated based on RECIST 1.1 and the irRECIST criteria.	From date of first therapy administration until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 24 months.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Wenquan Wang

Phone Number: +86 21 31587861

Email: wang.wenquan@zs-hospital.sh.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
70 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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