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

ConditionIRE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • IRE+chemotherapy

    Other intervention

    IRE+chemotherapy

  • chemotherapy

    Other intervention

    IRE+chemotherapy

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: IRE + chemotherapy continuationExperimental treatment 1 intervention
Group B: chemotherapy continuation alonePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

time from first antitumor treatment to death from any cause

Time frame
1year

Secondary outcomes

1

Progression-free survival (PFS)

Progression-free survival (PFS)

Time frame
1year
2

DCR ORR

RECIST 1.1

Time frame
3MONTH

Other outcomes

Sponsors and contacts

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