Stereotactic Centralized Ablative Radiotherapy for Locally Advanced Pancreatic Cancer: A Single-Arm Phase I Safety and Feasibility Study

NCT07173374 | Suspended Phase 1

• 1 other identifier: SDZLEC2025-283-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pancreatic Cancer; Locally Advanced Pancreatic Cancer

Keywords

SCART; Radiotherapy; Dose Escalation; Phase I Trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Overall Survival (OS)

  Up to 12 months after enrollment

• Local Control Rate (LCR)

  Up to 12 months after enrollment

• Objective Response Rate (ORR)

  Up to 12 months after enrollment

• Adverse Events (AEs)

  Up to 12 months after enrollment

Study Arms (1)

SCART Dose Escalation Arm

EXPERIMENTAL

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

Interventions

SCART Dose Escalation Arm RADIATION

Patients will receive SCART with escalating dose cohorts (10 Gy, 13 Gy, 16 Gy, and 19 Gy per fraction within the SCART region) using a standard 3+3 design. All patients will also receive background SBRT (25 Gy in 5 fractions) to the gross tumor volume and margin.

SCART Dose Escalation Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age 18-70 years, male or female. Histologically or cytologically confirmed diagnosis of pancreatic cancer. Locally advanced, unresectable disease without evidence of distant metastasis (based on imaging such as CT/MRI/PET-CT).
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Adequate bone marrow, liver, and renal function (per laboratory criteria). Life expectancy ≥ 3 months. Signed written informed consent prior to participation.

You may not qualify if:

• \- Evidence of distant metastasis. Prior abdominal radiotherapy. Prior systemic chemotherapy or immunotherapy within 4 weeks before enrollment. Concurrent participation in another interventional clinical trial. Severe comorbidities (e.g., uncontrolled cardiovascular, pulmonary, or infectious diseases).
• Pregnant or breastfeeding women. Known history of other malignancies within the past 5 years (except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ).
• Any condition that, in the investigator's judgment, would interfere with patient safety or compliance with the study protocol.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 0531, China

Location

Related Publications (20)

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MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jinbo Yue, Doctor

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label, single-arm dose-escalation study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department Radiation Oncology

Model Details: This is a single-arm, phase I dose-escalation study using a standard 3+3 design to evaluate the safety and feasibility of SCART (Stereotactic Centralized Ablative Radiation Therapy) in patients with locally advanced pancreatic cancer.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)