Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborator:
Ipsen
Studienleiter
Arndt Vogel, Prof. Dr. Principal Investigator Hannover Medical School Salah-Eddin Al-Batran, Prof. Dr. Study Director Institut für Klinische Krebsforschung IKF GmbH
Kontakt
Arndt Vogel, Prof. Dr. Kontakt: Phone: +49 511 532 9590 E-Mail: vogel.arndt@mh-hannover.de» Kontaktdaten anzeigen Johanna Riedel, Dr. Kontakt: Phone: +49 69 7601 4635 E-Mail: riedel.johanna@ikf-khnw.de» Kontaktdaten anzeigen
Studienlocations (3 von 10)
Helios Klinikum Bad Saarow 15526 Bad Saarow (Brandenburg) GermanyRekrutierend» Google-Maps Ansprechpartner: Daniel Pink, Dr.» Ansprechpartner anzeigenUniversitätsklinikum Halle (Saale) 06120 Halle (Sachsen-Anhalt) GermanyRekrutierend» Google-Maps Ansprechpartner: Marko Damm, Dr.» Ansprechpartner anzeigenLeberkrebszentrum Medizinische Hochschule Hannover Carl-Neuberg-Straße 1 30625 Hannover DeutschlandRekrutierend» Google-Maps Ansprechpartner: Arndt Vogel, Prof. Dr.» Ansprechpartner anzeigen
1. Time-on-treatment (Time Frame - at study end (approx. 30 months after FPI)): Time on treatment will be assessed as time from date of first dose of cabozantinib intake till date of permanent discontinuation of treatment.
Secondary outcome:
1. Overall survival (OS) (Time Frame - at 18 months after last patient randomized): Survival rates will be assessed from the date of first dose of cabozantinib intake to the date of death from any cause using Kaplan-Meier methods.
2. Progression free survival (PFS) (Time Frame - at study end (approx. 18 months after last patient randomized)): Survival rates for the different time points will be determined using the Kaplan-Meier analysis and RECIST 1.1.
3. Objective response rate (ORR) (Time Frame - at study end (approx. 18 months after last patient randomized)): Objective response rate will be defined as the proportion of subjects experiencing a confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1.
4. Duration of response (Time Frame - at study end (approx. 18 months after last patient randomized)): Time from documentation of tumor response to disease progression.
5. Treatment exposure (Time Frame - at study end (approx. 18 months after last patient randomized)): Time on treatment/dose intensity/dose reductions
6. Toxicity: o Treatment-related adverse events (TRAEs) o TRAE related treatment interruptions o TRAE related treatment modifications o TRAE related treatment discontinuations (Time Frame - at study end (approx. 18 months after last patient randomized)): All observed toxicities and side effects will be graded according to NCI CTCAE v5.0 and the degree of association of each with the study treatment assessed and summarized.
7. Change in ECOG Performance Status (Time Frame - at study end (approx. 18 months after last patient randomized)): Eastern Cooperative Oncology Group patient performance status (Grading from 0 to 5)
8. Change in ALBI Grade (Time Frame - at study end (approx. 18 months after last patient randomized)): ALBI score = -0.085 × (albumin g/L) + 0.66 × l g(TBil μmol/L)
9. Change in Child Pugh Score (Time Frame - at study end (approx. 18 months after last patient randomized)): Child-Pugh Classification Score (Grading from A to C)
10. Translational research (Time Frame - at study end (approx. 18 months after last patient randomized)): Correlation of biomarkers potentially associated with clinical efficacy (OS, PFS and ORR) of cabozantinib by NGS Oncopanel analysis and VEGF module expression analysis.