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2025-09-10
2028-09-01
2028-09-01
24
NCT07173374
Shandong Cancer Hospital and Institute
Shandong Cancer Hospital and Institute
INTERVENTIONAL
Stereotactic Centralized Ablative Radiotherapy for Locally Advanced Pancreatic Cancer: A Single-Arm Phase I Safety and Feasibility Study
This is a single-arm, phase I clinical study designed to evaluate the safety and feasibility of SCART (Stereotactic Centralized Ablative Radiation Therapy) dose escalation in patients with locally advanced pancreatic cancer. Pancreatic cancer carries a dismal prognosis, and the majority of patients are not surgical candidates at diagnosis. Radiotherapy is an important local treatment modality, but conventional approaches have shown limited efficacy. SCART is intended to deliver higher ablative doses to the tumor core while minimizing toxicity to surrounding normal tissues. In this trial, eligible patients will receive SCART with escalating dose levels using a standard 3+3 design. The primary endpoints are to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD). Secondary endpoints include overall survival (OS), local control rate (LCR), and objective response rate (ORR).
Pancreatic cancer is among the most aggressive malignancies and is associated with poor prognosis. The 5-year survival rate remains below 10%, and most patients present with unresectable disease at diagnosis. Radiotherapy plays a pivotal role in local disease control, yet conventional fractionated radiotherapy (CFRT) has demonstrated limited survival benefits. Stereotactic body radiotherapy (SBRT) allows delivery of higher biologically effective doses with improved local control, but further dose escalation is restricted by normal tissue tolerance. SCART (Stereotactic Centralized Ablative Radiation Therapy) is an innovative technique that delivers ablative radiation doses to selected intratumoral sub-volumes while maintaining lower doses at the tumor periphery. This spatial dose distribution has the potential to induce bystander effects and enhance biological efficacy beyond that achievable with uniform SBRT. This phase I study is designed to evaluate the safety and feasibility of SCART dose escalation in patients with locally advanced pancreatic cancer. Patients will be enrolled into sequential dose cohorts (10 Gy, 13 Gy, 16 Gy, and 19 Gy per fraction within the SCART region) using a standard 3+3 dose-escalation design. All patients will also receive background SBRT (25 Gy in 5 fractions) covering the gross tumor volume and margin. The primary objective is to determine dose-limiting toxicities (DLTs) and establish the maximum tolerated dose (MTD) of SCART. Secondary objectives include overall survival (OS), local control rate (LCR), objective response rate (ORR), and treatment-related adverse events (AEs). Exploratory analyses will investigate potential biomarkers and immune response modulation associated with SCART. The estimated enrollment is 12-24 patients, with an accrual period of 24 months and a minimum follow-up of 12 months.
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 |
|---|---|---|
2025-09-08 | N/A | 2025-09-08 |
2025-09-08 | N/A | 2025-09-15 |
2025-09-15 | N/A | 2025-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: SCART Dose Escalation Arm Patients will receive SCART with escalating dose cohorts (10 Gy, 13 Gy, 16 Gy, and 19 Gy per fraction within the SCART region). | RADIATION: SCART Dose Escalation Arm
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | The maximum tolerated dose (MTD) of SCART (Stereotactic Centralized Ablative Radiation Therapy) will be determined using a standard 3+3 dose-escalation design. MTD is defined as the highest dose level at which the incidence of dose-limiting toxicities (DLTs), graded according to CTCAE v5.0, does not exceed 33% of patients in that cohort. | Within 90 days after completion of radiotherapy |
| Dose-Limiting Toxicities (DLTs) | Incidence of dose-limiting toxicities (DLTs) graded according to the National Cancer Institute Common Terminology CTCAE v5.0. DLTs will be evaluated during the dose-escalation phase to assess the safety of SCART (Stereotactic Centralized Ablative Radiation Therapy). | Within 90 days after completion of radiotherapy |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival will be defined as the time from the start of SCART treatment to death from any cause. Patients still alive at the time of analysis will be censored at the date of last follow-up. | Up to 12 months after enrollment |
| Local Control Rate (LCR) | Local tumor control will be assessed according to RECIST v1.1 criteria based on radiographic imaging (CT/MRI). Local control rate will be calculated as the proportion of patients without local progression. | Up to 12 months after enrollment |
| Objective Response Rate (ORR) | Objective tumor response will be evaluated using RECIST v1.1 criteria by imaging assessment. | Up to 12 months after enrollment |
| Adverse Events (AEs) | Incidence and severity of treatment-related adverse events (AEs) will be graded according to CTCAE v5.0 during and after radiotherapy. | Up to 12 months after enrollment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jinbo Yue, Doctor Phone Number: 0531-67626442 Email: jbyue@sdfmu.edu.cn |
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:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
