IRE After Chemotherapy for Locally Advanced Pancreatic Cancer

NCT07799935 | Recruiting

• 1 other identifier: PNANO-HOPE1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, controlled, exploratory Phase II clinical study. Approximately 60 eligible patients with locally advanced pancreatic cancer who have received three cycles of chemotherapy induction and have non-progressive disease will be enrolled. All patients must be considered unresectable by MDT review and must provide written informed consent. Participants will be randomized 2:1. Forty patients will undergo open IRE followed by continuation of the original chemotherapy regimen; twenty patients will continue the original treatment regimen alone. OS, PFS, tumor response, QoL, safety, and postoperative outcomes will be observed.

Conditions

IRE

Keywords

IRE

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Time from first antitumor treatment to death from any cause

  Up to 48 months

• Progression-Free Survival (PFS)

  Time from randomization to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.

  Up to 48 months

Secondary Outcomes (2)

• Disease Control Rate (DCR)

  Every 2 months up to 18 months

• Objective Response Rate (ORR)

  Every 2 months up to 18 months

Study Arms (2)

IRE + chemotherapy continuation

EXPERIMENTAL

Other: IRE

chemotherapy continuation alone

PLACEBO COMPARATOR

Other: PLACEBO

Interventions

IRE OTHER

IRE

IRE + chemotherapy continuation

PLACEBO OTHER

continue the original treatment regimen alone

chemotherapy continuation alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years, any sex.
• Primary tumor biopsy confirms pancreatic adenocarcinoma.
• Non-progressive disease (PR or SD) after three cycles of chemotherapy induction.
• Locally advanced pancreatic cancer with \>180-degree involvement of major vessels (celiac axis, superior mesenteric artery, superior mesenteric vein, or portal vein), confirmed unresectable by MDT review.
• No prior palliative chemotherapy (except neoadjuvant/adjuvant chemotherapy discontinued \>6 months); no other systemic antitumor therapy.
• At least one measurable lesion per RECIST 1.1.
• Adequate organ and marrow function: hemoglobin ≥9.0 g/dL; neutrophils ≥1.5×10⁹/L; platelets ≥100×10⁹/L; TBIL ≤3×ULN; AST and ALT ≤5.0×ULN; serum creatinine ≤1.5×ULN or CrCl \>60 mL/min.
• ECOG Performance Status 0-1.
• Expected survival ≥3 months.
• Patients of childbearing potential and partners agree to use contraception.
• Voluntary written informed consent.

You may not qualify if:

• Refusal to receive systemic chemotherapy or possible surgery.
• Metastasis to other sites (liver, peritoneum, lung, bone, brain).
• History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ).
• Severe uncontrolled comorbidities (NYHA III/IV heart failure, unstable angina, uncontrolled arrhythmia/hypertension, active infection, uncontrolled diabetes, uncontrolled effusions/ascites requiring drainage, severe portal hypertension/cavernoma, gastric outlet obstruction, respiratory insufficiency requiring oxygen).
• Major surgery within 30 days before screening.
• EGFR monoclonal antibody within 30 days before screening.
• Allergy to any drug or component used in this protocol.
• Known HIV infection or chronic hepatitis B/C.
• Unresolved toxicity ≥CTCAE grade 2 from prior treatment (except anemia, alopecia, skin pigmentation, chemotherapy-induced neurotoxicity).
• Any other reason judged by the investigator to make participation inappropriate.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, 300308, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

CN (1)