araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: A Retrospective Pharmacokinetics and Pharmacogenomics Research of Imatinib in Gastrointestinal Stromal Tumor Treatment

Summary: For patients of GIST (Gastrointestinal Stromal Tumor), Imatinib has been widely used in GIST with KIT or PDGFRA sensitive mutations. From clinical points of view, individual differences often occur between different patients, leading diverse effect in ADR and drug effect. Meanwhile, the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic and other factors. In this research, we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations, plasma trough concentration and drug effect, the association between ADME-associated SNP, Target/Receptor/Pathway-associated SNP, trough concentration and TKI adverse effect. Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.

Detailed description: The plasma concentration of Imatinib were established. The ADME-associated SNPs included are CYP3A4, CYP3A4, CYP1A1, CYP2C9, CYP2C19, ABCB1, ABCG2, ABCC4, SLC22A1, SLCO1B3 and so on. The Target/Receptor/Pathway-associated SNP s included KIT, PDGFRA, PDGFRB, FLT1, FLT3, MAPK1, SHC1, CCL5, CXCL14 and so on. The somatic mutations included are KIT, PDGFRA, BRAF and so on.

Eligibility: Inclusion Criteria:
  -  The main patient entry criteria included: age≥ 18 years; histologically and cytologically proved GIST; Eastern cooperative oncology group performance status (ECOGPS)≤2; adequate hematological,renal,and hepatic functions.
  Exclusion Criteria:
  -  uncontrolled systemic disease,and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.

Relevance to patient case: definitely relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study

Summary: Patients with gastric gastrointestinal stromal tumors will receive robotic resection.

Detailed description: Gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract. Approximately 60% of tumors develop in the stomach.Before, patients with gastric gastrointestinal stromal tumors would receive open or laparoscopic surgery. However, gastrointestinal stromal tumors located at special sites, such as cardia, were hardly treated. Recently, the robot was used to remove gastric gastrointestinal stromal tumors. In this study, the robot will be used to remove gastric gastrointestinal stromal tumors. Then, we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.

Eligibility: Inclusion Criteria:
  1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable.
  2. Patients with gastric gastrointestinal stromal tumors scheduled for robotic resection and between the age of 18 and 80 years old without considering sex.
  3. American Society of Anesthesiologists (ASA) physical status I-III.
  4. Participants can follow the visit plan.
  Exclusion Criteria:
  1. Patients certified by a doctor that doesn't fit to participate in this study.
  2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received coronary artery bypass grafting (CABG) recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
  3. Patients with gastrointestinal stromal tumor with distant metastasis.
  4. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
  5. Patients with gastrointestinal operations and complicated abdominal operations.
  6. Patients with severe malnutrition (albumin≤30g/L, weight loss in half a year＞10%, Subjective Global Assessment (SGA) classification C, body mass index ＜18, Hb＜70g/L).
  7. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
  8. Patients participated other subjects 3 months before this subject.
  9. Sponsors or researchers directly involved in the testing or their family members.

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246

Summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade serous ovarian cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll at least 25 evaluable patients.


Eligibility: Inclusion Criteria:
  -  Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
  -  Disease Progression between 4 weeks - 6 months after the last platinum-based treatment was administered
  -  At least a single measurable lesion
  -  Adequate organ function prior to registration
  -  Toxicities from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (defined by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0). Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
  -  ECOG performance status of 0 to 2
  Exclusion Criteria:
  -  Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2
  -  Hypersensitivity to PLD or to any of the excipients
  -  Unable to undergo imaging by either CT scan or MRI
  -  Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
  -  Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
  -  Is taking concurrent (or within 4 weeks prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed. Palliative limited radiation therapy for pain reduction is allowed

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib.

Summary: To compare the efficacy of surgery followed by sunitinib with surgery followed by imatinib in GIST patients with progression on imatinib;To investigate the optimal therapy after surgery in GIST patients with focal or multifocal progression in imatinib

Detailed description: Primary Endpoint: To evaluate the progression free survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib Secondary Endpoint：To evaluate the overall survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib the relationship of c-kit secondary mutation and progression free survival of surgery followed by TKI therapy the safety and tolerability of the two therapy.
  Statistics:All the statistical analysis is performed using SPSS version 20.0 (IBM corporation, United States). Pearson's chi-squared test was used to compare categorical variables. PFS and OS analyses were estimated with Kaplan-Meier method and log-rank test and multivariable analyses were performed to assess survival difference. A two sided p-value of <0.05 was considered statistically significant.

Eligibility: Inclusion Criteria:
  1. .Histopathological diagnosis of metastatic GIST.
  2. . After the treatment of imatinib, imatinib 400mg/day after treatment, the tumor generalized.
  3. . Patients with generalized progress were satisfied with tumor reduction after imatinib resistance for various reasons.
  4. at least 1 month after surgery for imatinib treatment or sunitinib treatment.
  5. at least one imaging assessment was received after surgery.
  6. . Complete clinical data and follow-up data.
  Exclusion Criteria:
  1. . Before operation, he was treated with sunitinib
  2. . Patients receiving tumor reduction were not satisfied with the standard of the reduction of tumor.
  3. . The treatment of imatinib or sunitinib after surgery was less than 1 month.
  4. . Incomplete clinical data or follow-up data.

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor

Summary: To achieve optimal clinical outcomes with imatinib in GIST patients, it is crucial to maintain standard imatinib dose. Skin rash is a relatively common and sometimes severe adverse event of imatinib in GIST patients and may affect imatinib compliance. Our previous retrospective study suggested that severe skin rash induced by imatinib can be managed by systemic steroid without imatinib dose interruption or reduction. This phase II study was conducted to evaluate the efficacy and safety of systemic steroid in GIST patients with imatinib-associated severe skin rash.


Eligibility: Inclusion Criteria:
  -  Age 18 years or older, at the time of acquisition of informed consent
  -  Histologically confirmed metastatic and/or advanced (unresectable or recurrent) GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
  -  Patients with metastatic and/or advanced (unresectable or recurrent) GISTs, receiving imatinib as adjuvant or neo adjuvant, palliative chemotherapy for pre-or post- operations
  -  imatinib-associated severe skin rash which was defined as grade 3 skin rash or grade 2 skin rash with pruritus over grade 2

Relevance to patient case: definitely relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor

Summary: Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor


Eligibility: Inclusion Criteria:
  -  18-70 years old Chinese;
  -  Definite diagnosis or endoscopic ultrasonography, CT and other highly suspected Chinese patients with gastric stromal tumors;
  -  Patients voluntarily signed informed consent and have been orally informed of the specific trial plan.
  Exclusion Criteria:
  -  Patients with gastric stromal tumors with distant metastasis who cannot be treated by laparoscopic surgery;
  -  Combined heart , cerebrovascular , liver , kidney , and hematopoietic system serious primary disease;
  -  gastric stromal tumors with severe digestive tract hemorrhage endanger the immediate surgical treatment of life;
  -  The investigator considers that it is not suitable for this test.

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Expanded Access to Everolimus, for an Individual Patient With GIST (Gastrointestinal Stromal Tumors)(CTMS#18-0019)

Summary: Single patient treatment with everolimus.



Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: This Study Evaluates KRT-232, a Novel Oral Small Molecule Inhibitor of MDM2, for the Treatment of Patients With (p53WT) Merkel Cell Carcinoma Who Have Failed Anti-PD-1/ PD-L1 Immunotherapy

Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy. Inhibition of MDM2 is a novel mechanism of action in MCC.
  This study is Phase 2, Open-Label, Single-Arm Study of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma


Eligibility: Inclusion Criteria:
  -  ECOG performance status of 0 to 1
  -  Histologically confirmed MCC. Disease must be measurable, with at least 1 measurable lesion by RECIST 1.1
  -  MCC expressing p53WT based on any CLIA or FDA approved test
  -  Patients must have failed (i.e., relapsed or were refractory to) treatment with at least one PD-1 inhibitor or PD-L1 inhibitor for MCC
  -  Fresh or archival tumor tissue must be submitted for biomarker assessment. Archival tissue samples must have been obtained from biopsy performed ≤ 2 years before the date of signing the informed consent for this study. Adequate hematological, hepatic, and renal function within 14 days prior to the first dose of KRT-232:
  1. Hematologic: ANC ≥1.0 × 109/L in the absence of growth factors during the prior 7 days; platelet count ≥100 × 109/L
  2. Hepatic: total bilirubin ≤2.0 times the upper limit of normal (ULN), unless Gilbert's Syndrome; aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) ≤2.5 ULN
  3. Renal: estimated creatinine clearance >45 mL/min by Cockcroft Gault:
  Exclusion Criteria:
  -  Concurrent anticancer treatment such as chemotherapy, cytoreductive therapy, immune therapy, or cytokine therapy within 28 days or approximately 5 half-lives prior to the first dose of KRT-232
  -  Radiation therapy within 2 weeks prior to the first dose of KRT-232
  -  Toxicity from prior radiation therapy that has not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0 or Grade 1 (with the exception of Grade 2 alopecia)
  -  Participation in another interventional clinical trial within the past 4 weeks of the first dose of KRT-232
  -  Prior treatment for MCC with histone deacetylase (HDAC) inhibitors or BCL-2 inhibitors
  -  Patients previously treated with MDM2 antagonist therapies or p53-directed therapies
  -  History of major organ transplant
  -  Patients with known central nervous system (CNS) metastases that are previously untreated

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Early Access Program (EAP) for Avapritinib in Patients With Locally Advanced Unresectable or Metastatic GIST

Summary: This is a US, multicenter, open-label expanded access program to provide access to avapritinib until such time that avapritinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.


Eligibility: Inclusion Criteria:
  1. Patient is ≥ 16 years of age.
  2. Diagnosis of unresectable or metastatic GIST
  3. The patient is not eligible for an ongoing study of avapritinib or cannot access an ongoing study of avapritinib.
  4. Patient has received 3 or more TKI therapies including imatinib, or the patient has GIST that carries a mutation in exon 18 of the PDGFRA gene (such as D842V).
  5. The patient has adequate vital organ function, including heart, lungs, liver, kidneys, bone marrow and endocrine, and is expected to tolerate therapy with a TKI.
  6. Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.
  Exclusion Criteria:
  1. Patients who have poor organ function as defined by one or more of the following laboratory parameters;
  1. Total bilirubin > 2 × ULN; or > 3 × ULN in the presence of Gilbert's Disease;
  2. Platelet count < 75 × 10^9/L.
  2. Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4
  3. Patient has had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days of the first dose of avapritinib.
  4. Patient has a history of a cerebrovascular accident or transient ischemic attacks within 1 year prior to the first dose of program drug.
  5. Patient has a known risk of intracranial bleeding, such as a brain aneurysm or history of subdural or subarachnoid bleeding.
  6. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib.
  7. Women who are pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 7 days before the randomization. Females with β-hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the Sponsor, after pregnancy has been ruled out. Females of non- childbearing potential (postmenopausal for more than 1 year; bilateral tubal ligation; bilateral oophorectomy; hysterectomy) do not require a serum β-hCG test.
  8. Women who are breast feeding.

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Jejunoileal vs Gastric GIST in the Era of Imatinib.

Summary: Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib.
  Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.


Eligibility: Inclusion Criteria:
  -  Any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST.
  Exclusion Criteria:
  -

Relevance to patient case: definitely relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Advanced Refractory Solid Tumors With TP53 Mutations Register Study

Summary: The efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor will be investigated in advanced refractory solid tumors patients with TP53 mutation .

Detailed description: TP53 is a well-known tumor suppressor gene. Multiple studies have demonstrated that TP53 mutations are poor prognostic factor in advanced solid tumor, the TP53 gene is frequently inactivated by mutation in a majority of human tumors. However, no effective TP53 -based therapy has been successfully translated into clinical cancer treatment. So, investigators intend to review and evaluate the efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor for TP53 mutation in advanced refractory solid tumors patients from a real-world population.

Eligibility: Inclusion Criteria:
  1. Is equal to or greater than 18 years of age.
  2. Histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (Eastern Cooperative Oncology Group (ECOG) 3 and 4).
  3. Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  4. Patients must be able to provide blood samples or tissue samples for NGS (Next Generation Sequencing) testing for understanding the TP53 gene status. The amount of blood and tissue samples should be able to meet the requirements of DNA extraction and quality control.
  5. Adequate baseline organ system function.
  6. Patients could receive treatment program from MTB (Molecular Tumor Board).
  7. No prior treatment with PARP combined with VEGFR inhibitions.
  8. Ability to understand and the willingness to provide a written informed consent document.
  Exclusion Criteria:
  1. Women who are pregnant or breastfeeding.
  2. Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.
  3. Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
  4. Active infection requiring systemic therapy.
  5. Patients unable to swallow orally administered medication.
  6. Prior treatment with PARP or VEGFR inhibitions.
  7. According to the investigator'judgment, there are serious, uncontrollable risks to patients'safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.

Relevance to patient case: not relevant