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

NCT ID: NCT07173374

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2028-09-01

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).

Detailed Description

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.

Conditions

Pancreatic Cancer; Locally Advanced Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

SCART Dose Escalation Arm

Intervention Type: 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.

Interventions

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) 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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Jinbo Yue

Director of Department Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinbo Yue, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Locations

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Countries

China

Central Contacts

Jinbo Yue, Doctor

Role: CONTACT

jbyue@sdfmu.edu.cn

0531-67626442

Facility Contacts

Jinbo Yue, Doctor

Role: primary

jbyue@sdfmu.edu.cn

0531-67626442

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Other Identifiers

SDZLEC2025-283-01

Identifier Type: -

Identifier Source: org_study_id