IRENCT07795619
HCCANANO-HOPE1: IRE After Chemotherapy for Locally Advanced Unresectable Perihilar Cholangiocarcinoma
A study testing IRE+chemotherapy and chemotherapy in people with IRE, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IRE
- What is being tested?
- IRE+chemotherapy and chemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
Li Huikai, MD, 18622228639, tjchlhk@126.com
About this study
Official title: 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
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
- Being tested
- IRE+chemotherapy, chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRE+chemotherapyOther
IRE+chemotherapy
chemotherapyOther
IRE+chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: IRE+chemotherapy |
| chemotherapy continuation alone | Placebo comparator | Not described Receives: Other: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
time from first antitumor treatment to death from any cause
Measured: 1year
Secondary outcomes (2)
Progression-free survival (PFS)
Progression-free survival (PFS)
Measured: 1year
DCR ORR
RECIST 1.1
Measured: 3MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IREStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795619
- Sponsor's protocol ID
- IRE-HOPE-CCA
- Status last verified
- Jul 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07795619
- Acronym / sponsor ID
- IRE-HOPE-CCA
- Conditions
- IRE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRE + chemotherapy continuation | Experimental | Other: IRE+chemotherapyIRE 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. |
| chemotherapy continuation alone | Placebo comparator | Other: chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRE+chemotherapyIRE+chemotherapy | Other | IRE + chemotherapy continuation |
| chemotherapyIRE+chemotherapy | Other | chemotherapy continuation alone |
Primary outcome
Overall survival (OS)
Time frame: 1year
time from first antitumor treatment to death from any cause
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 1year
DCR ORR
Time frame: 3MONTH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRE+chemotherapy and chemotherapy in people with IRE, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huikai Li (18622228639, tjchlhk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.