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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

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Following the attainment of the maximum treatment response through imatinib mesylate administration, typically occurring within 6-12 months, as evidenced by two consecutive imaging evaluations, the tumor exhibited no further reduction in size, thus necessitating the selection of surgical intervention.

According to the characteristics of the location of the tumor, the surgeon decides the surgical approach based on the existing literature and the availability of surgical equipment, including:

1. Local transanal resection (TA)
2. Local resection transsacralapproach
3. Local resection via perineal approach
4. Local resection transvaginal approach

1. For patients with c-KIT exon 11 mutation, imatinib mesylate, 400mg, qd.
2. For patients with c-KIT exon 9 mutation, imatinib mesylate, 600mg or 800mg, qd.

According to the characteristics of the location of the tumor, the surgeon decides the surgical approach based on the existing literature and the availability of surgical equipment, including:

1. Local transanal resection (TA)
2. Local resection transsacralapproach
3. Local resection via perineal approach
4. Local resection transvaginal approach

Local resection

Weizhong Jiang, MD

Jiabin Zheng

Prior to the implementation of preoperative imatinib mesylate therapy, a considerable percentage (ranging from 34.5% to 67.5%) of individuals diagnosed with rectal gastrointestinal stromal tumors (GIST) underwent abdominoperineal resection (APR), a surgical procedure that involved the removal of the anus and necessitated a permanent colostomy.

This study aims to investigate the safety and viability of an organ-preserving approach involving preoperative imatinib mesylate treatment in conjunction with local resection for rectal GIST, specifically targeting patients with c-KIT gene mutations.

Prior to the implementation of preoperative imatinib mesylate therapy, a considerable percentage (ranging from 34.5% to 67.5%) of individuals diagnosed with rectal gastrointestinal stromal tumors (GIST) underwent abdominoperineal resection (APR), a surgical procedure that involved the removal of the anus and necessitated a permanent colostomy.

Previous studies have established that preoperative administration of imatinib mesylate effectively diminishes the size of rectal gastrointestinal stromal tumors (GIST) and enhances the likelihood of sphincter preservation. After initiating preoperative imatinib mesylate treatment, the sphincter preservation rate has notably escalated from 4.2% to 33.0%-94.9%.

In theory, lymph node resection is not required for Gastrointestinal Stromal Tumors (GIST); the local excision of rectal GIST enables sphincter preservation and yields satisfactory anal function and quality of life (QoL). Various surgical techniques are utilized for local excision, including traditional transanal (TA) and transanal minimally invasive surgery (TAMIS) approaches.

This study aims to explore the safety and feasibility of an organ-preservation strategy of preoperative imatinib mesylate combined with local resection in rectal gastrointestinal stromal tumor (GIST), specifically for patients with c-KIT gene mutations.

Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST

Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST: an Open-label, Single-arm, Phase III Trial（PIRKER）

Rectum intact, owing to no total mesorectal excision (TME), no locoregional regrowth unless amenable to limited, curative (R0) salvage surgery by local excision (LE) and no permanent stoma (including a never reversed protective stoma, or a stoma owing to toxicities and/or poor functional outcomes)

The proportion of participants who remain disease-free at 3 years after surgery

The local recurrence rate is defined as the incidence detection of a tumor involving the bowel wall only that occurs after LE or TME

The proportion of participants who remain survival at 3 years after surgery

The R0 resection rate is defined as the rate of R0 resection

Quality of life accessed by EORTC-QLQs-C30 and EORTC-QLQs-CR29 questionnaire

Fujian Medical University Union Hospital

Associate professor

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
Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST	NCT05970900	Gastrointestina...	Imatinib Mesyla... Local resection	18 Years - 80 Years	Fujian Medical University Union Hospital

Spots Global Cancer Trial Database for gastrointestinal stromal tumor of rectum