HCCANANO-HOPE1: IRE After Chemotherapy for Locally Advanced Unresectable Perihilar Cholangiocarcinoma

NCT07795619 | Recruiting

• 1 other identifier: IRE-HOPE-CCA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Irreversible electroporation is a non-thermal ablative technology that uses high-voltage electric pulses to create permanent nanopores in tumor cell membranes, leading to apoptosis or other forms of cell death. Because the mechanism is primarily non-thermal, IRE may better preserve extracellular matrix, bile ducts, vessels, and other critical structures than thermal ablation, which is relevant for tumors adjacent to major vascular or biliary anatomy. The main anticipated clinical value of IRE in these protocols is local disease control and potential survival benefit when used after induction therapy in patients with non-progressive disease. The procedure may be performed by open or percutaneous access according to tumor location, safety considerations, and institutional expertise. Perioperative management, imaging guidance, and post-procedure monitoring will follow institutional standards. Post-IRE gastrointestinal dysfunction may occur. Symptom-directed supportive care, including electroacupuncture where appropriate and approved by the investigator, may be used as supportive management. Such care is not intended to replace oncologic treatment and will be recorded as concomitant treatment when administered.

Conditions

IRE

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  time from first antitumor treatment to death from any cause

  1year

Secondary Outcomes (2)

• Progression-free survival (PFS)

  1year

• DCR ORR

  3MONTH

Study Arms (2)

IRE + chemotherapy continuation

EXPERIMENTAL

IRE may be performed by open or percutaneous access, based on lesion location, vascular or biliary anatomy, patient condition, and operator judgment. Procedure planning, anesthesia, imaging guidance, perioperative antibiotics, and post-procedure monitoring will follow institutional standards.

Other: IRE+chemotherapy

chemotherapy continuation alone

PLACEBO COMPARATOR

Other: chemotherapy

Interventions

IRE+chemotherapy OTHER

IRE+chemotherapy

IRE + chemotherapy continuation

chemotherapy OTHER

IRE+chemotherapy

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, both sexes
• Histologically or cytologically confirmed locally advanced perihilar cholangiocarcinoma (Bismuth-Corlette type III/IV or equivalent)
• Non-progressive disease (PR or SD) after 3 cycles of standard induction chemotherapy
• MDT-confirmed unresectable disease after induction therapy
• No prior palliative systemic therapy
• At least one measurable lesion per RECIST 1.1
• ECOG Performance Status 0-1
• Adequate organ and marrow function: Hb ≥9.0 g/dL, ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, TBIL ≤3×ULN, AST/ALT ≤5×ULN, serum creatinine ≤1.5×ULN or CrCl \>60 mL/min
• Life expectancy ≥3 months
• Willing to use contraception if of childbearing potential
• Written informed consent

You may not qualify if:

• \- Refusal to receive systemic chemotherapy or possible surgery
• Metastasis to liver, peritoneum, lung, bone, brain, or other distant sites
• History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ)
• Severe uncontrolled comorbidities (e.g., NYHA III/IV heart failure, unstable angina, uncontrolled arrhythmia, uncontrolled hypertension, active infection, uncontrolled diabetes, significant effusions, severe portal hypertension, gastric outlet obstruction, respiratory insufficiency)
• Major surgery within 30 days before screening
• EGFR monoclonal antibody or EGFR-TKI within 30 days before screening
• Allergy to any protocol-related drug or component
• Known HIV infection or chronic hepatitis B/C (active)
• Unresolved toxicity ≥CTCAE grade 2 from prior treatment (except anaemia, alopecia, skin pigmentation, or chemotherapy-induced neuropathy)
• Any condition 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

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Huikai Li

CONTACT

18622228639; tjchlhk@126.com

Study Design

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

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-07

Locations

CN (1)