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Liver Transplantation

Felipe Alconchel, MD, PhD

Juan Ángel Fernández-Hernández, MD, PhD

Pablo Ramírez, MD, PhD

Jerónimo Martínez, MD, PhD

Francisco Sánchez-Bueno, MD, PhD

Ricardo Robles, MD, PhD

Liver Transplantation for Unresectable GIST Liver Metastases

Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases

Hospital Universitario Virgen de la Arrixaca

MD, PhD, Principal Investigator

Antineoplastic Agents

Anti-Dyskinesia Agents

Amino Acids

Other Dietary Supplements

Sunitinib

Entacapone

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antiparkinson Agents

Tyrosine

Catechol

Entacapone 200mg tablet (Orion pharma,Switzerland) by mouth, three times a day and then escalated to final dose of 1.0 grams three times per day within one week, until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first.

And Imatinib mesylate 400mg tablet by mouth, once a day until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first.

Bin Li, MD

This study evaluates the combination of entacapone and imatinib in the treatment of gastrointestinal stromal Tumors who have progressed on the setting of at least Imatinib and Sunitinib. 5 participants will be included in this open-label observatory study.

The eligibility criteria are patients whose histologically confirmed disease which is currently metastatic/unresectable gastrointestinal stroma tumor (GIST) of c-KIT E11 mutation genotype. He received imatinib as the first-line treatment and no progression within the first 6 months (no primary resistance to imatinib), with disease progression following treatment with at least imatinib and sunitinib, and at least 1 measurable lesion (the longest diameter≥ 10mm). Age should be more or equal 18 years with adequate hematologic and end-organ function and good performance ((ECOG PS) ≤ 2, or 3 (the symptoms were definitely caused by GIST itself).

This study is single group assignment and open label. The intervention/treatment is Entacapone combined with Imatinib. Entacapone began with 200mg tablet (Orion pharma, Switzerland) by mouth, three times a day and then escalated to final dose of 1.0 grams three times per day within one week, until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. Imatinib mesylate 400mg tablet by mouth, once a day until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. Periodically routine blood test including liver and kidney function, troponin and electrocardiogram were conducted throughout the entire clinical course.

Clinic visits are performed at 16 points: visit 1, baseline, and then follow up after first dose as planned: 1st month, and every 2 months in the first year, followed by every 3 months until 3 years or 31 days after withdraw. The study design is visualized in Figure 1 below.

Entacapone Combination With Imatinib for Treatment of GIST

Entacapone in Combination With Imatinib Mesylate for Treatment of Patients With Gastrointestinal Stromal Tumors(GIST) Following Failure of at Least Imatinib and Sunitinib

De-identified individual participant data for all primary and secondary outcome measures will be made available.

According to Criteria CTCAE5.0, the ratio of AE and SAE which were defined by the Common Terminology Criteria for Adverse Events, CTCAE.

The ORR is the proportion of the patients who achieved complete response (CR) or partial responses(PR) according to CHOI criteria.

The data was collected using EORTC QLQ-C30 V3.0 questionnaire

Xiangya Hospital of Central South University

Director of Center for molecular medicine, Xiangya hospital, Central South University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Liver Transplantation for Unresectable GIST Liver Metastases	NCT04825470	Liver Diseases Liver Cancer Liver Metastase... Liver Neoplasms Liver Mass Liver Carcinoma Liver Transplan... Liver Transplan... GIST GIST, Malignant Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Metastases to L... Metastatic Live... Metastasis Metastases Liver Transplan... Transplant Onco...	Liver Transplan...	18 Years -	Hospital Universitario Virgen de la Arrixaca
Liver Transplantation for Unresectable GIST Liver Metastases	NCT04825470	Liver Diseases Liver Cancer Liver Metastase... Liver Neoplasms Liver Mass Liver Carcinoma Liver Transplan... Liver Transplan... GIST GIST, Malignant Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Metastases to L... Metastatic Live... Metastasis Metastases Liver Transplan... Transplant Onco...	Liver Transplan...	18 Years -	Hospital Universitario Virgen de la Arrixaca
Entacapone Combination With Imatinib for Treatment of GIST	NCT04006769	Gastrointestina...	Entacapone Imatinib Mesyla...	18 Years -	Xiangya Hospital of Central South University

Spots Global Cancer Trial Database for gastrointestinal stromal tumor, malignant