Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer
LyRICX
1 other identifier
interventional
320
1 country
34
Brief Summary
This is a multi-center, open label, randomized phase II trial for patients with previously untreated metastatic or locally advanced esophagogastric cancer, using a pick the winner design to identify the best combination therapy in terms of progression free survival and neurotoxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2019
Longer than P75 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2018
CompletedFirst Posted
Study publicly available on registry
December 5, 2018
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedJuly 1, 2025
June 1, 2025
6.3 years
October 29, 2018
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression free survival
To compare the progression free survival
42 months
Number of participants with treatment-related Neurotoxicity
Number of participants with treatment-related Neurotoxicity according to CTCAE v4.0
42 months
Secondary Outcomes (6)
Overall survival
54 months
response rate
42 months
adverse events
42 months
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ C30))
42 months
percentage subsequent treatment lines
42 months
- +1 more secondary outcomes
Other Outcomes (7)
Tumor micro environment
54 months
Stromal markers in blood
54 months
Growth velocity of patient derived tumor organoids
54 months
- +4 more other outcomes
Study Arms (3)
Liposomal irinotecan, leucovorin and 5FU
EXPERIMENTALIV Nal-IRI 80 mg/m² (expressed as irinotecan hydrochloride (HCl) salt), folinic acid 400 mg/m², fluorouracil 2400 mg/m² over 46 h, every 2 weeks. No addition of nivolumab is possible for this arm
Carboplatin and capecitabine
EXPERIMENTALIV and PO Capecitabine 1000 mg/m2 and carboplatin area under the curve (AUC5), every three weeks. In case of PD-L1 CPS ≥5 only: nivolumab, dose according to local standard, iv day 1
oxaliplatin and capecitabine
EXPERIMENTALIV and PO Capecitabine 1000 mg/m2 and oxaliplatin 130 mg/m2, every three weeks. In case of PD-L1 CPS ≥5 only: nivolumab, dose according to local standard, iv day 1
Interventions
PO Capecitabine
Eligibility Criteria
You may qualify if:
- Patients must provide written informed consent according to International Conference on Harmonization (ICH)/Guideline for Good Clinical practice (GCP), and national/local regulations prior to any screening procedures.
- Male or female adult patients (\> 18 years).
- Patients with histologically confirmed diagnosis of metastatic or irresectable human epidermal growth (HER2) negative adenocarcinoma of the stomach or oesophagus; patients with HER2 positive disease are eligible when treatment with trastuzumab is contraindicated. If histology cannot be obtained, cytology is acceptable to prove metastatic disease.
- Patients with metastatic or irresectable adenocarcinoma of the stomach or oesophagus not pre-treated with chemotherapy or radiotherapy for irresectable or metastatic disease. Palliative radiotherapy on the primary tumor or a metastatic lesion is allowed if other untreated lesions eligible for evaluation are present.
- Measurable disease as assessed by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) (WHO) performance status 0-2
- Patient has adequate bone marrow and organ function as defined by the following laboratory values:
- Absolute Neutrophil Count (ANC) \> 1.5 x 109 /L
- Hemoglobin (Hgb) \> 5.6 mmol/L
- Platelets \> 100 x 109 /L
- Serum total bilirubin within ≤ 1.5 x ULN (upper limit of normal); or total bilirubin \< 3.0 x upper limit of normal (ULN) with direct bilirubin within normal range in patients with well documented Gilbert's syndrome; biliary drainage is allowed for biliary obstruction
- Serum creatinine \< 1.5 x ULN or creatinine clearance \>30 mL/min/1.73 m2
- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \< 2.5x ULN within normal range or \< 5.0 x ULN if liver metastases are present
- If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test, beta-human chorionic gonadotropin (β-hCG) documented 72 hours prior to the first administration of study drug. If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug and after the end of treatment as recommended.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
You may not qualify if:
- Prior systemic treatment for metastatic or irresectable stomach or oesophageal cancer.
- Evidence of disease progression within six months after completion of adjuvant or neoadjuvant treatment (whichever is last) containing a fluoropyrimidine and/or platinum compound and/or irinotecan; progression on neoadjuvant chemoradiation with carboplatin area under the curve (AUC2) and paclitaxel 50 mg/m2 within this time frame is allowed.
- All target lesions in a radiation field without documented disease progression. 11
- Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
- Past or current malignancy other than entry diagnosis interfering with prognosis of metastatic esophagogastric cancer.
- Known uncontrollable hypersensitivity or contraindications to any of the components of liposomal irinotecan (Nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, leucovorin, oxaliplatin, carboplatin. Patients with previous dose reductions or delays are eligible.
- Complete dihydropyrimidine dehydrogenase deficiency .
- Patient has active, uncontrolled bacterial, viral or fungal infection(s) requiring systemic therapy.
- Patient has known past or active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Signs of interstitial lung disease (ILD)
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation in the clinical study.
- Use of other investigational drugs within 30 days of enrollment.
- Patient is enrolled in any other clinical protocol or investigational trial that will interfere with the primary endpoint.
- Patients who in the investigators' opinion may be unwilling, unable or unlikely to comply with requirements of the study protocol.
- Current use or any use in last two weeks of strong cytochrome P4503A (CYP3A-enzyme), CYP2C8, and/or strong UDP glucuronosyltransferase (UGT1A) inhibitors/inhibitors
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ, Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Meander MC
Amersfoort, Netherlands
Academic Medical Center, Medical Oncology
Amsterdam, 1100 DD, Netherlands
Rijnstate Ziekenhuis
Arnhem, 6815 AD, Netherlands
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Reinier de Graaf Gasthuis
Delft, 2625 AD, Netherlands
Nij Smellinghe
Drachten, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Catherina Ziekenhuis
Eindhoven, Netherlands
Treant Zorggroep
Emmen, Netherlands
Zuyderland Medisch Centrum
Geleen, Netherlands
Admiraal de Ruijter Ziekenhuis
Goes, 4460 AA, Netherlands
Sint Jansdal
Harderwijk, Netherlands
Elkerliek ziekenhuis
Helmond, Netherlands
Tergooi ziekenhuizen
Hilversum, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Treant zorggroep
Hoogeveen, 7909 AA, Netherlands
Dijklander ziekenhuis
Hoorn, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
Canisius Wilherlmina ziekenhuis
Nijmegen, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
VieCurie
Roermond, 6043 CV, Netherlands
Laurentius Ziekenhuis
Roermond, Netherlands
Bravis ziekenhuis locatie Roosendaal
Roosendaal, 4708 AE, Netherlands
Ikazia ziekenhuis
Rotterdam, Netherlands
Maasstadziekenhuis
Rotterdam, Netherlands
Rivierenland Ziekenhuis
Rotterdam, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
UMCU
Utrecht, 3508 GA, Netherlands
Isala Klinieken
Zwolle, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jan M Prins, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 29, 2018
First Posted
December 5, 2018
Study Start
May 1, 2019
Primary Completion
July 31, 2025
Study Completion (Estimated)
July 1, 2026
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share