Clinical trial NCT06844773: Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).
Official title: A Single-center, Prospective, Observational Cohort Study of Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Unresectable Locally Advanced Pancreatic Cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 36
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with locally advanced pancreatic cancer who are evaluated by imaging at Shanghai Zhongshan hospital, aged between 70 and 85 years old, will be screened and enrolled after discussion by the ZSPAC multidisciplinary expert committee.

Brief summary: 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.


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.

Primary outcomes:
measure: 1-year survival rate
timeFrame: From the date of first therapy administration to one year later
Secondary outcomes:
measure: Toxicity and side effects and tolerability assessment
timeFrame: From the date of first therapy administration to within 90 days, up to 24 months
measure: event-free survival throughout the enrolled subject population
timeFrame: 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.
measure: the proportion of participants that completed chemoradiotherapy
timeFrame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
measure: the proportion ofparticipants that completed all planned courses
timeFrame: From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.
measure: Objective response rate (ORR) tumor target lesions in the entire subject population all planned courses
timeFrame: 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.
measure: Disease control rate (DCR) of tumor target lesions in the entire subject population all planned courses
timeFrame: 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.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
References: