NCT07795619Recruiting
HCCANANO-HOPE1: IRE After Chemotherapy for Locally Advanced Unresectable Perihilar Cholangiocarcinoma
A Prospective, Randomized Controlled Phase II Clinical Study of Sequential or Non-sequential Irreversible Electroporation After Chemotherapy Induction in Patients With Locally Advanced Unresectable Perihilar Cholangiocarcinoma
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07795619
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Apr 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Refusal to receive systemic chemotherapy or possible surgery
- Major surgery within 30 days before screening
- Unresolved toxicity ≥CTCAE grade 2 from prior treatment (except anaemia, alopecia, skin pigmentation, or chemotherapy-induced neuropathy)
Other illness
- 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)
- Allergy to any protocol-related drug or component
- Known HIV infection or chronic hepatitis B/C (active)
- Any condition judged by the investigator to make participation inappropriate
Lab values
- EGFR monoclonal antibody or EGFR-TKI within 30 days before screening
Other
- Metastasis to liver, peritoneum, lung, bone, brain, or other distant sites
Who the study is looking for
- \- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Cancer Hospital Airport Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.