IRE after chemotherapy for locally advanced unresectable perihilar cholangiocarcinoma
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
Run by Tianjin Medical University Cancer Institute and Hospital · NCT07795619 · Data updated 2026-11-12
This study tests irreversible electroporation plus chemotherapy after induction therapy in adults with unresectable, non-progressing perihilar cholangiocarcinoma to see if local disease control improves.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT07795619 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-75 with histologically confirmed locally advanced, unresectable perihilar cholangiocarcinoma (Bismuth III/IV or equivalent) who are non-progressive after induction chemotherapy and have measurable disease.
✕Probably not a fit
Patients with metastatic disease, progression after induction therapy, or significant comorbidities may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial uses irreversible electroporation (IRE) to ablate tumors near critical bile ducts and vessels after initial chemotherapy in patients whose disease is non-progressive and unresectable. It allows open or percutaneous IRE depending on tumor location and safety considerations, with perioperative care and imaging guided by standard practices. Participants must have measurable disease, good performance status, and adequate organ function, and must have completed prior induction chemotherapy without progression. The study may provide symptomatic management and requires ongoing monitoring for post-procedure GI dysfunction.
Why it matters
Potential benefit: If successful, patients could experience better local control and potential survival advantages after induction therapy.
How similar studies have gone: Previous work has explored IRE for challenging tumors near critical structures, with some demonstrations of local control, but results vary and this exact combination after induction chemotherapy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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 Exclusion Criteria: \- 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
Where it's running
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Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Huikai Li
- Email: tjchlhk@126.com
- Phone: 18622228639
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
IRE after chemotherapy for locally advanced pancreatic cancer
This study tests whether adding irreversible electroporation after chemotherapy helps people with locally advanced pancreatic cancer who can’t be surgically removed.
-
IRE after targeted immunotherapy in HCC with portal vein tumor thrombus
This study tests whether adding irreversible electroporation (IRE) after a targeted immunotherapy regimen helps people with liver cancer and portal vein tumor thrombus who can’t have surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.