Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
38
Countries
1
Sites
7
advanced, non resectable or metastatic cholangio- or gallbladder carcinoma after failure to respond to a previous gemcitabine treatment
To examine the efficacy of a combination therapy of trifluridine/tipiracil and nanoliposomal irinotecan in patients with advanced, non resectable or metastatic cholangio- and gallbladder carcinoma after failure to respond to a previous gemcitabine-based treatment.
Key facts
- Sponsor
- Heinrich-Heine-Universitaet Duesseldorf
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 2 Oct 2025 → ongoing
- Decision date (initial)
- 2025-07-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- SERVIER Deutschland GmbH · Servier Affaires Médicales
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To examine the efficacy of a combination therapy of trifluridine/tipiracil and nanoliposomal irinotecan in patients with advanced, non resectable or metastatic cholangio- and gallbladder carcinoma after failure to respond to a previous gemcitabine-based treatment.
Secondary objectives 1
- The secondary objectives are progression-free survival rate at 4 months defined as the proportion of patients with non-progressive disease 4 months after inclusion by intention to treat analysis. Likewise the median overall survival and the proportion of patients with an objective response according to RECIST 1.1 will be calculated. Moreover safety (type, grade and frequency of AEs/SAEs) and the analysis of quality of life (EORTC QLQ-30 and the EQ-5D5L questionnaires) are also secondary objectives of this study.
Conditions and MedDRA coding
advanced, non resectable or metastatic cholangio- or gallbladder carcinoma after failure to respond to a previous gemcitabine treatment
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10017620 | Gallbladder carcinoma | 10029104 |
| 27.0 | PT | 10008593 | Cholangiocarcinoma | 100000004864 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period Patients will be treated with trifluridin/tipiracil (Lonsurf®) (30 mg/m2 / dose twice daily on days 1-5) and nanoliposomal irinotecan (Onivyde®) (at a dose of 70 mg/m2 on day 1) in 2 week cycles until radiological progression or inacceptable toxicity
|
Not Applicable | None | ||
| 2 | Follow-up period Patients will be followed-up for 6 months every 3 months after end of treatment to collect data on life quality, disease status and survival.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Histologically or cytologically confirmed, non-resectable, locally advanced or metastatic cholangiocarcinoma or gall bladder carcinoma
- Measurable or assessable disease according to RECIST 1.1
- Documented disease progression after prior gemcitabine or gemcitabine containing therapy or intolerance to such a treatment. Examples of permitted therapies include, but are not limited to: a) Single agent gemcitabine); b) Any gemcitabine-based regimen, with or without maintenance gemcitabine
- Patients with available molecular tumor profiling may only be included if they are not eligible for approved targeted therapies or if they reject approved targeted therapies. Eligibility for such therapies is determined by the local interdisciplinary tumor board or molecular tumor board, based on the results of molecular testing, clinical criteria, and the patient’s preference.
Exclusion criteria 2
- CNS metastases
- Clinically significant gastrointestinal disorders including bleeding, inflammation, occlusion, or diarrhea > grade 1
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Median progression free survival (PFS) assessed by the local investigator at each site (time from first administration of chemotherapy to the date of radiological or clinical tumor progression or death of any cause whichever comes first).
Secondary endpoints 5
- Progression-free survival rate at 4 months defined as the proportion of patients with non-progressive disease 4 months after inclusion by intention to treat analysis
- Median overall survival (time interval from first administration of chemotherapy to date of death from any cause)
- Proportion of patients with an objective response according to RECIST 1.1
- Type, frequency and severity of adverse events according to NCI CTCAE version 5.0 specifying seriousness and expectedness (AE, SAE, SUSAR)
- Health related QoL according to EORTC QLQ C30 and the EQ-5D-5L
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Lonsurf 15 mg/6.14 mg film-coated tablets
PRD4021875 · Product
- Active substance
- Trifluridine
- Substance synonyms
- TRIFLUOROTHYMIDINE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg/m2 milligram(s)/sq. meter
- Max total dose
- 9999 mg/g milligram(s)/gram
- Max treatment duration
- 99 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC59 — -
- Marketing authorisation
- EU/1/16/1096/003
- MA holder
- LES LABORATOIRES SERVIER (SURESNES)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lonsurf 20 mg/8.19 mg film-coated tablets
PRD4021874 · Product
- Active substance
- Trifluridine
- Substance synonyms
- TRIFLUOROTHYMIDINE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg/m2 milligram(s)/sq. meter
- Max total dose
- 9999 mg/g milligram(s)/gram
- Max treatment duration
- 99 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC59 — -
- Marketing authorisation
- EU/1/16/1096/006
- MA holder
- LES LABORATOIRES SERVIER (SURESNES)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Onivyde pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
PRD6811022 · Product
- Active substance
- Irinotecan
- Pharmaceutical form
- CONCENTRATE FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 70 mg/m2 milligram(s)/sq. meter
- Max total dose
- 9999 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 99 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX19 — IRINOTECAN
- Marketing authorisation
- EU/1/16/1130/001
- MA holder
- LES LABORATOIRES SERVIER (SURESNES)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/11/933
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Heinrich-Heine-Universitaet Duesseldorf
- Sponsor organisation
- Heinrich-Heine-Universitaet Duesseldorf
- Address
- Universitaetsstrasse 1, Bilk Bilk
- City
- Duesseldorf
- Postcode
- 40225
- Country
- Germany
Scientific contact point
- Organisation
- Heinrich-Heine-Universitaet Duesseldorf
- Contact name
- Prof. Dr. med. Christoph Roderburg
Public contact point
- Organisation
- Heinrich-Heine-Universitaet Duesseldorf
- Contact name
- Prof. Dr. med. Christoph Roderburg
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Acnos Pharma GmbH ORG-100034601
|
Aachen, Germany | Code 14 |
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 38 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
I. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Aachen AöR
Klinik für Gastroenterologie, Stoffwechselerkrankungen und internistische Intensivmedizin, Pauwelsstrasse 30, 52074, Aachen
University Hospital Cologne AöR
Klinik für Gastroenterologie und Hepatologie, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Bonn AöR
Medizinische Klinik und Poliklinik I Onkologische Gastroenterologie, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Duesseldorf AöR
Klinik für Gastroenterologie, Hepatologie und Infektiologie, Moorenstrasse 5, Bilk, Duesseldorf
Krankenhaus Nordwest GmbH
Institut für Klinisch-Onkologische Forschung, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2025-10-02 | 2025-10-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517330-18 redacted | V02F |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | V01F |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biobank TRITICC-2 | V01F |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Schwangerschaft Partner TRITICC-2 | V02F |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Schwangerschaft Partnerin TRITICC-2 | V02F |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Schwangerschaft Studienteilnehmerin TRITICC-2 | V02F |
| Subject information and informed consent form (for publication) | L1_SIS and ICF TRITICC-2 | V02F |
| Subject information and informed consent form (for publication) | L2_Other subject information material Studienausweis | V01F |
| Subject information and informed consent form (for publication) | L2_Patiententagebuch TRITICC-2 | V02F |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lonsurf | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Onivyde | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis de 2024-517330-18 | V02F |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-03 | Germany | Acceptable 2025-07-28
|
2025-07-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-13 | Germany | Acceptable | 2025-08-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-10 | Germany | Acceptable | 2025-11-10 |