Clinical Research Directory

Development of a Multimodal AI System for GIST Management

Background: Gastrointestinal Stromal Tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract. Accurate pre-operative diagnosis, risk stratification, and genotyping are critical for determining the appropriate surgical approach and targeted therapy (such as Imatinib). However, current methods often rely on invasive postoperative pathology and expensive genetic testing. Study Objective: The purpose of this study is to develop and validate a multimodal Artificial Intelligence (AI) model that integrates clinical data, CT radiomics (imaging features), and pathomics (digital pathology features) to improve the precision of GIST management. Study Design: This is a prospective, observational study. The researchers will recruit patients with suspected gastric submucosal tumors who are scheduled for surgery or biopsy at The Fourth Hospital of Hebei Medical University. Core Tasks: The AI model will be trained to perform three specific tasks: Diagnosis: Distinguish GISTs from other non-GIST mesenchymal tumors (e.g., leiomyomas, schwannomas). Risk Assessment: Stratify GISTs into risk categories (e.g., Low vs. High risk) to predict malignant potential. Genotyping: Predict specific gene mutations (e.g., KIT or PDGFRA mutations) to guide immunotherapy or targeted therapy. Methodology: Patient data (CT scans, pathology slides, and clinical history) will be collected and analyzed by the AI system. The AI's predictions will be compared against the "Gold Standard" results derived from postoperative pathological examination and Next-Generation Sequencing (NGS). This study is non-interventional; the AI results will not affect the standard of care received by the patients.

Observational Registry Data on GIST Patients

This is a longitudinal, multi-center, registry study, collecting data via a web-based portal in patients with GIST (Gastrointestinal Stromal Tumor) from hospitals in Taiwan.

Imatinib TDM in GIST

Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.

A Prospective Study on Predicting Recurrence Risk of Postoperative High-risk GISTs in NED State Based on MRD Detection Via Liquid Biopsy

The goal of this single-center, prospective, observational cohort study is to learn whether tumor-informed minimal residual disease (MRD) testing in blood can predict recurrence in 66 patients with high-risk gastrointestinal stromal tumor (GIST) who are not currently receiving postoperative adjuvant therapy. The main questions it aims to answer are: Can changes in MRD during follow-up predict tumor recurrence? How closely do MRD results agree with contrast-enhanced computed tomography (CT) findings, and can MRD identify recurrence earlier than CT? Can tumor genomic features, changes in MRD, and clinicopathological features be combined to develop a model for predicting recurrence risk? Participants will have their surgical tumor tissue analyzed, provide blood samples for MRD testing, and undergo regular clinical follow-up and contrast-enhanced CT examinations for 3 years. Participants may choose to receive and discuss their MRD results. This study will not assign or change treatment based on MRD results. Recurrence and treatment decisions will remain based on routine clinical assessment, primarily contrast-enhanced CT and multidisciplinary review.

Temozolomide (TMZ) In Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST)

Funding Source - FDA OOPD FDA-approved products for patients with unresectable or metastatic GIST include therapies such as imatinib and sunitinib. Although there are FDA-approved products for the treatment of advanced/metastatic GIST, these therapies are known to be ineffective in the SDH-mutant/deficient subtype and no known effective therapies exist. The purpose of this study is to investigate SDH-Mutant/Deficient Gastrointestinal Stromal cancer's response to the drug Temozolomide (TMZ) and aim to improve patient outcomes. Temozolomide is approved by the FDA for the treatment of newly diagnosed glioblastoma multiforme (GBM) and refractory anaplastic astrocytoma cancers. Temozolomide is considered experimental because it is not approved by the FDA for the treatment of SDH-Mutant/Deficient Gastrointestinal Stromal Tumor.

Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments

To evaluate the safety of DCC-2618 in patients with unresectable, metastatic, or recurrent gastrointestinal stromal tumor (GIST) who have received three or more prior therapies

Phase 2 Study to Evaluate the Efficacy of Regorafenib in Specific GIST Mutation Subsets (KIT Exon 17, 18, or 14 Mutation and SDHB Deficient GIST) in the Post-imatinib Second-line Setting.

To learn if regorafenib can help to control the disease.

Integrated Cancer Repository for Cancer Research

The iCaRe2 is a multi-institutional resource created and maintained by the Fred \& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.

Preoperative Imatinib and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor

The goal of this clinical trial is to learn what dose of the drug fampridine can be given safely together with imatinib (Gleevec) in patients with gastrointestinal stromal tumor (GIST) with a DNA mutation in exon 11 of the KIT gene. The main questions this study aims to answer are: * What is the maximum dose of fampridine that can be given safely together with imatinib (Gleevec)? * Is the combination of the two drugs efficacious against the tumor? Participants will: * Take the drugs before tumor surgery (preoperative treatment) for at least 2 months with the option to continue for a longer period of time if treatment seems safe and effective. * Visit the clinic at the scheduled appointments for checkups and tests.

The Efficacy and Safety of Temozolomide in SDH-deficient GIST

The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.

GIST Oral Paclitaxel(Liporaxel)

The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression.

Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor

The purpose of this study is to evaluate the efficacy and safety of rivoceranib and paclitaxel combination therapy in patients with P-glycoprotein overexpressing GIST who failed standard treatment with imatinib, sunitinib, and regorafenib.

Assessment of Compliance With Monitoring Conducted by a Physician in Person or by a Nurse in Remote Monitoring

This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (\<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).

A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101)

This study consists of Dose escalation part and Expansion part. In Dose Escalation Part, the maximum tolerated dose of combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (GIST) who are judged to be refractory to imatinib, estimate the recommended dose, evaluate safety and pharmacokinetics, and observe the antitumor effect. Expansion part consists of 3 arms. In Arm A, the efficacy and safety will be evaluated, which of the combination of pimitespib and imatinib in patients with GIST who have failed imatinib at doses below the MTD determined in Dose Escalation Part. In Arm B, the efficacy and safety of pimitespib monotherapy will be evaluated and the therapeutic effect of imatinib administration after pimitespib will be evaluated in an exploratory manner. In Arm C, the efficacy and safety of sunitinib monotherapy will be evaluated as reference data.

SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST

This is an open label, single arm, phase 2 trial investigating bezuclastinib plus sunitinib in patients with GIST who have previously progressed on sunitinib.

A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Express c-Kit

This open-label clinical trial will evaluate the safety and tolerability of NN3201 in subjects with advanced and/or metastatic solid tumors known to express c-Kit.

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

The purpose of this research is to test if mutations (changes in DNA) in exons (segment of DNA or RNA containing information that has the instructions for making proteins) in the KIT gene can be used to predict the body's response to standard of care treatment.

5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk

In this study, the investigators aim to investigate the efficacy and safety of 5 years of adjuvant imatinib treatment in patients with tumor rupture defined by Nishida classification or those with a tumor size 10cm or larger and a mitotic index of 10/50HPFs or higher.

Observational Study, for Quality Assessment, of Sarcoma in European and Latin American Multidisciplinary NETWORK

Post-authorisation, multicentric, observational, retrospective and prospective study to assess quality of care of sarcoma patients in expert and non-expert centers by analysing correlation of quality items and outcomes such as relapse free survival, overall survival, percentage of amputation, etc. Expert pathology peer review will be performed to detect differences between expert and non-expert centers as well as differences in treatment and patient prognosis. Tumor samples of 4 types of sarcoma would also be included in translational research to detect biomarkers and produce preclinical models.

The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

This is a prospective, single-center, observational study to explore the correlation between ripretinib exposure and the efficacy and safety in patients with advanced gastrointestinal stromal tumors

Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA

This is a prospective, multicenter, observational real-world study to explore the Avapritinib therapy in GIST patients who definited Non-exon18 Mutations of PDGFRA.

A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors

This is a prospective, multicenter, observational real-world study to explore the therapy patterns and clinical outcomes of Avapritinib in patients with metastatic or unresectable gastrointestinal stromal tumors.

Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

This is a prospective, multicenter, observational real-world study to explore the second-line Pharmacotherapy patterns and clinical outcomes in GIST patients who progressed on or were intolerant to first-line anticancer treatment.