Actively Recruiting
Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2026-03-23
40
Participants Needed
8
Research Sites
314 weeks
Total Duration
On this page
Sponsors
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead Sponsor
S
Servier Deutschland GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study trial is a prospective, multicentre, exploratory, single-arm, open-label phase II study to evaluat ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma
CONDITIONS
Official Title
Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient provides signed informed consent.
- Patient is 18 years or older at time of consent.
- Histologically confirmed curatively resected intrahepatic cholangiocarcinoma without metastatic spread (R0-resected).
- Proven IDH1 mutation confirmed by certified test on tumor tissue.
- Completed standard of care adjuvant chemotherapy prior to trial inclusion.
- Recent radiologic imaging (within 6 weeks) showing no tumor present at enrollment.
- ECOG Performance Status of 0 or 1.
- Adequate blood, liver, and kidney function as determined by investigator.
- Adequate blood clotting ability to allow ivosidenib treatment; patients on warfarin must switch to low molecular weight heparin before trial.
- Willingness to provide liquid biopsy, tumor tissue samples, and re-biopsy if safe during recurrence.
- Agreement to use effective contraception or abstain from sexual intercourse during treatment and for 6 months after.
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before starting treatment.
- Willing and able to comply with all study procedures, treatment, visits, and follow-up.
You will not qualify if you...
- Presence of metastatic or incompletely resected biliary tract cancer.
- Previous treatment with an IDH1 inhibitor.
- Presence of tumors other than intrahepatic cholangiocarcinoma except certain treated skin or cervical cancers unless disease-free for 5 years.
- Concurrent systemic immunotherapy, chemotherapy, or hormone therapy not described in the protocol.
- Receiving other anti-cancer treatments outside the trial except palliative radiotherapy.
- Cirrhosis stage B or worse, or cirrhosis with history of hepatic encephalopathy or significant ascites.
- Known allergic or hypersensitive reactions to treatment components.
- Serious illnesses or medical conditions within 12 months prior to trial start.
- Active, uncontrollable infections.
- QTc interval greater than 480ms or conditions increasing risk of heart rhythm problems.
- Active disseminated intravascular coagulation.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- Immunodeficiency or chronic steroid/immunosuppressive therapy within 7 days before first dose.
- Other serious medical conditions posing high risk or reducing likely benefit.
- Female patients who are pregnant, breastfeeding, or planning pregnancy during and 6 months after treatment.
- Persons incarcerated or involuntarily institutionalized by order of court or authorities.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Uniklinik RWTH Aachen
Aachen, Germany, 52074
Actively Recruiting
2
Universitätsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
3
Krankenhaus Nordwest
Frankfurt, Germany, 60488
Actively Recruiting
4
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Actively Recruiting
5
Universitätsmedizin Göttingen
Göttingen, Germany, 37099
Actively Recruiting
6
Uniklinikum Jena
Jena, Germany, 7747
Actively Recruiting
7
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
8
Klinikum rechts der Isar TU München
München, Germany, 81675
Actively Recruiting
Research Team
T
Thorsten Götze, Prof. Dr.
CONTACT
J
Johanna Riedel, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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