araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma

Summary: The purpose of this study is to determine whether bevacizumab and nimustine are effective in the treatment of recurrent high grade glioma and to explore whether there is any subgroup being sensitive to this therapeutic protocol.

Detailed description: Although anti-angiogenesis therapy for glioblastoma(GBM) are showing promise, GBMs often develop resistance to treatment within months or weeks after salvage therapy. There are still no effective markers to predict the response rate to bevacizumab.
  So the investigators initiate a single-arm Phase II study to evaluate the efficacy and tolerability of bevacizumab and nimustine regimen and to explore the predictive markers in patients with recurrent high-grade glioma.

Eligibility: Inclusion Criteria:
  -  Histological diagnosis of primary tumor as high-grade gliomas (WHO III or IV)
  -  All patients should complete radiotherapy and chemotherapy for primary gliomas
  -  Enhanced MRI and magnetic resonance spectroscopy showed unequivocal evidence of tumor recurrence or progression.
  -  Those patients underwent surgical resection after tumor recurrence can also be enrolled if histological diagnosis of GBM is available, and MRI within 3 days after operation is needed.
  -  The patients with recurrent gliomas didn't undergo bevacizumab therapy before enrollment.
  -  The time to be enrolled should be more than 90 days after the radiation therapy, more than 28 days after operation for recurrent tumor or prior chemotherapy.
  -  Eastern Cooperative Oncology Group score: 0-2
  -  Written informed consent
  -  Laboratory test: Neutrophil count > 1.5*10^9/L, platelet count > 100*109/L, hemoglobin > 8 g/dL, blood urea nitrogen and creatinine < 1.5 upper limit of normal(ULN), blood total bilirubin and conjugated bilirubin < 1.5 ULN, alanine aminotransferase(ALT) and aspartate aminotransferase(AST) < 3 ULN, alkaline phosphatase(AKP) < 2 ULN
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Allergic to administered drugs
  -  Radiation therapy in the previous 90 days before enrollment
  -  The patients with recurrent gliomas were treated with bevacizumab therapy before enrollment.
  -  Acute infection in need of antibiotics intravenously
  -  Participation in other clinical trials in the 90 days before enrollment

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)

Summary: This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).

Detailed description: This is a first-in-human, multi-center, open-label clinical study with separate Dose Escalation and Expansion Phases to assess preliminary safety, tolerability, and efficacy of KPT-9274, a dual inhibitor of PAK4 and NAMPT, in patients with advanced solid malignancies (including sarcoma, colon, lung, etc.) or NHL for which all standard therapeutic options considered useful by the investigator have been exhausted.

Eligibility: Inclusion Criteria:
  -  Advanced solid malignancies or NHL for which all standard therapeutic options considered useful have been exhausted.
  -  Must have objective evidence of progressive disease on study entry.
  -  Advanced solid malignancies: Measureable disease as defined by RECIST 1.1.
  -  NHL: Measureable disease including target lesion(s) as defined by the Lugano Classification for initial evaluation and staging.
  -  Must have a site of disease amenable to biopsy and be a candidate for biopsy.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  -  Dose Expansion Phase (KPT-9274 + niacin ER cohort only): Patient tumors NAPRT1 and IDH1 tumor status must be determined at the central laboratory prior to enrollment.
  -  Life expectancy of ≥3 months.
  Exclusion Criteria:
  -  Known central nervous system (CNS) disease or leptomeningeal involvement, regardless of response to prior therapy.
  -  Major surgery within 4 weeks before C1D1.
  -  Active infection with completion of therapeutic antibiotics, antivirals, or antifungals within one week prior to C1D1. Prophylactic antibiotics, antivirals or antifungals are permitted.
  -  Known history of Human Immunodeficiency Virus (HIV); HIV testing is not required as part of this study.
  -  Known, active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen).
  -  Significant diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea that could interfere with the absorption of KPT-9274.
  -  Active peptic ulcer disease or other active gastrointestinal bleeds.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Dose-Escalation Study of FT-2102 as a Single Agent and in Combination With Azacitidine in Patients With AML or MDS With an IDH1 Mutation

Summary: This Phase 1/1b study will utilize a multicenter, open-label dose-escalation design to evaluate the safety, PK, and PD of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one or more intermittent dosing schedules. Approximately 48 patients will be enrolled in the dose-escalation portion of this study in one or more schedules followed by approximately 14 patients in expansion cohorts


Eligibility: Inclusion Criteria:
  -  Pathologically proven acute myeloid leukemia or high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) that is either relapsed or refractory to standard therapy, or for whom standard treatments are contraindicated.
  -  Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site
  -  Good kidney and liver function
  -  No prior organ allograft
  -  For fertile men and women, agreement to use effective contraceptive methods duration of study participation and 90 days after
  Exclusion Criteria:
  -  Previously treated with any prior IDH1 targeted therapy
  -  History of prior malignancy unless disease free for > 2 years.
  -  Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
  -  Treatment with major surgery (requiring general anesthesia) within one month prior to study entry
  -  Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g. malabsorption, gastric or small bowel resection, etc.) deemed to jeopardize intestinal absorption
  -  Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
  -  Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication
  -  Known HIV positivity
  -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: A Study to Confirm the Long-term Safety and Effectiveness of Kalydeco in Patients With Cystic Fibrosis Who Have an R117H-CFTR Mutation, Including Pediatric Patients

Summary: The purpose of this study is to confirm the long-term safety and effectiveness of Kalydeco® (ivacaftor) in US CF patients with the R117H-CFTR mutation <18 years of age and to describe the long-term safety and effectiveness of Kalydeco in CF patients with the R117H-CFTR mutation overall and in patients ≥18 years. The long-term safety and effectiveness of Kalydeco will be examined in totality through the evaluation of the primary outcome measures.

Detailed description: Patient follow-up (i.e., collection of outcomes data after treatment initiation) in the Non-Interventional Cohort will be at least 36 months. The study also includes retrieval of retrospective data entered into the registry for 36 months before the initiation of Kalydeco treatment, from patients matched for both the Interventional and Non-Interventional Cohorts. This will permit a within-group comparison of outcomes before and after Kalydeco treatment for effectiveness and safety.

Eligibility: Inclusion Criteria:
  Interventional Cohort
  -  Male or female with confirmed diagnosis of CF
  -  Must have at least 1 allele of the R117H-CFTR mutation
  -  Enrolled in the US CFF Patient Registry at the time of entry into the study
  -  Patients will be 6 to <18 years of age on the date of signed ICF, and where appropriate,date of assent
  -  If sexually active, male patients who can father a child and female patients of childbearing potential must agree to meet the contraception requirements
  Non Interventional Cohort
  -  Male or female with confirmed diagnosis of CF
  -  Must have at least 1 allele of the R117H-CFTR mutation
  -  Enrolled in the US CFF Patient Registry
  -  With a record of Kalydeco treatment initiation from 01 January 2015 through 31 December 2016
  Historical Cohort
  -  Patients with CF in the CFF Patient Registry as of 01 January 2009
  -  Must have at least 1 allele of the R117H-CFTR mutation
  -  Patients with no evidence of any prior Kalydeco exposure
  Exclusion Criteria:
  Interventional Cohort
  -  History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
  -  Pregnant, planning a pregnancy, breastfeeding, or not willing to follow contraception requirements
  -  Abnormal liver function at enrollment
  -  Abnormal renal function at enrollment
  -  History of solid organ or hematological transplantation
  -  Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days before Enrollment.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

Summary: To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma.

Detailed description: Photodynamic therapy (PDT) is a way of producing tissue necrosis with light after prior administration of a photosensitizing agent. The most important advantages include the possibility of combining PDT with other target therapies and repeat the process as needed with a favorable outcomes. The combination of diverse therapeutic modalities is one of the new strategies to enhance oncologic treatments for pancreatic cancer. In order to overcome the limitations of each treatment modalities and to prevent the development of resistance, the application of PDT combined with target therapies, without increasing the toxicity for the patient, is being widely investigated.
  PDT has been only extensively studied for the treatment of various superficial skin cancers in the Europe but not available in the United States and Japan due to the overlapping treatment fields. In Korea, the use of first-generation and second-generation photosensitizers are part of the study of Gastroenterology, Dermatology, Otolaryngology, and Gynecology.
  Recently, although the investigators have introduced PDT using novel photosensitizers has not yet been used for the treatment of pancreatic cancers. This study aim to determine the safety and efficacy of photodynamic therapy with a novel photosensitizer in locally advanced hilar cholangiocarcinoma.

Eligibility: Inclusion Criteria:
  1. Locally advanced cholangiocarcinoma confirmed to be unsuitable for surgical resection
  2. Exhibiting disease progression without distant metastasis after conventional chemoradiation therapy at multidisciplinary team discussion in Asan Medical Center
  3. Pathologically proven cholangiocarcinoma
  4. have a negative pregnancy test if appropriate
  5. ECOG(Eastern Cooperative Oncology Group) Score 0-2
  6. patients to give informed consent and age more than >19 years
  Exclusion Criteria:
  1. age less than 18 years
  2. previous history of PDT
  3. uncorrectable coagulopathy
  4. refuse to participate
  5. pregnancy
  6. recent participation in another clinical research trial within 30 days
  7. presence of porphyria or hypersensitivity to photosensitizer
  8. Creatinine clearance < 45ml

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samples

Summary: The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples

Detailed description: This is a non-interventional, observational study of archived human tissue samples; no surgical procedures will be required and no treatment will be provided as part of this study. Approximately 150 archived tissue samples obtained from patients with iCCA or mixed HCC-CCA will be analyzed for somatic alteration status and will include cholangiocarcinoma-specific FGFR2 fusion isoforms.

Eligibility: Inclusion Criteria:
  -  If required by law or local regulations (i.e., the sample is from an identifiable subject), signed written informed consent should be granted prior to use of the sample in the study
  -  ≥ 18 years of age
  -  Histologically or cytologically confirmed iCCA or mixed HCC-CCA, who are/were eligible for systemic therapy (samples collected prior to initiation of the systemic therapy may be submitted for testing)
  -  Have one or more formalin fixed and paraffin embedded blocks available. If blocks are not evaluable, 7-10 unstained, non-baked slides with 5-micron thick sections with at least 20% tumor tissue should be available. (Potential participants who are scheduled to undergo surgical treatment may agree to provide surplus of tissues not required for diagnosis and have to provide informed consent prior to the surgery.)
  Exclusion Criteria:
  -  Not applicable: Patients must meet all of the inclusion criteria.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

Summary: This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation.

Detailed description: Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will receive mature dendritic cells for a total of 12 vaccine doses.The DC vaccine will be given subcutaneously every four weeks. Peripheral blood will be taken two weeks after injection each time to monitor the immune response.

Eligibility: Inclusion Criteria:
  -  The patient signed "informed consent" voluntarily;
  -  The age of patient is between 18 and 70 years;
  -  The tumor can be resected and tumor resection rate ≥80%;
  -  IDH1R132H mutation can be confirmed by immunohistochemistry or real-time quantitative PCR;
  -  Peripheral blood lymphocytes absolute value is not less than 0.8 × 106;
  -  KPS score ≥70 ;
  -  The patient has normal bone marrow reserve and normal liver and kidney function ( The bone marrow, liver and kidney function must be confirmed by Laboratory examination to meet the requirements of participating in the study within 3 days before the first acceptance of IDH1R132H-DC tumor vaccine therapy): Medium neutrophil absolute value ≥1,500 / mm3; hemoglobin> 10g / dL; platelet count> 100,000 / mm3; total bilirubin <1.5 × ULN; alanine aminotransferase / aspartate aminotransferase <2.5 × ULN; serum creatinine <1.5 × ULN;
  -  Normal heart function ;
  -  Better follow-up and compliance;
  -  For women of childbearing age (15 to 49 years)，pregnancy test must be negative 7 days before starting this study. Male and female patients of childbearing potential must agree to use effective contraceptive measures to ensure that during the study period and three months after cessation of treatment will not be pregnant.
  Exclusion Criteria:
  -  The patient did not sign "informed consent" or signed unvoluntarily.
  -  Non-glioma patients
  -  Drugs for brain or antibody therapy had been used 4 weeks before the start of this study
  -  Active infection
  -  Human immunodeficiency virus (HIV) positive
  -  Hepatitis C or hepatitis B infective
  -  Pregnancy or breast-feeding women
  -  Patients did not agree to use effective contraception during treatment and the following 3 months.
  -  Patients also participated in other clinical studies.
  -  The subjects researchers believe are not suitable for participation or completion of the study.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors

Summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.


Eligibility: Inclusion Criteria:
  -  For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.
  -  For dose escalation for all combinations: The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.
  -  For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  -  For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  -  For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  -  For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).
  -  For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >2 lines of systemic treatment for advanced or metastatic TNBC.
  -  Have adequate organ function.
  -  Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  -  Have discontinued all previous therapies for cancer.
  Exclusion Criteria:
  -  Have current acute leukemia.
  -  Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Clinical Trial of Adjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy Compared With Adjuvant Chemotherapy Alone in Patients With Gallbladder Carcinoma and Extrahepatic Cholangiocarcinoma

Summary: The present study is designed to determine whether adjuvant concurrent chemoradiotherapy improves overall survivals.

Detailed description: The role of adjuvant radiotherapy in gallbladder carcinoma (GBCA) or extrahepatic cholangiocarcinoma (EHCC) is unknown. A retrospective study suggested that chemoradiotherapy provides greater benefit than chemotherapy alone in GBCA patients. SWOG S0809, a phase II study showed that adjuvant chemoradiotherapy has promising efficacy in GBCA or EHCC. The present phase III clinical trial is designed to compare adjuvant concurrent chemoradiotherapy with chemotherapy alone.

Eligibility: Inclusion Criteria:
  -  The patients with pathologic diagnosis of gallbladder carcinoma (GBCA) or extrahepatic cholangiocarcinoma (EHCC) after radical resection.
  -  The patients with pathologic stage T2-4 or N1 in R0 resection or positive resection margins (R1).
  -  Aged 18 to 70 years old, male or female, body condition score generally ECOG 0～2, expected survival ≥ 6 months.
  -  Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators:
  -  Blood: Absolute neutrophil count > 1.5 × 109 / L, Platelet count > 100 × 109 / L, Hb > 8.0g/dl.
  -  Liver function: serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 2.5 times the upper limit of normal.
  -  Renal function: creatinine less than 1.5 times the upper limit of normal.
  -  Patients who can understand the circumstances of this study and signed informed consent.
  Exclusion Criteria:
  -  Pregnancy, breast-feeding patients；
  -  Patients received prior anticancer therapy for the current malignancy or upper abdominal radiotherapy or chemotherapy at any time.
  -  Patients with malignant ascites.
  -  Patients with purulent and chronic infected wounds which delayed healing.
  -  Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease;
  -  Patients has a history of mental illness and difficult to control;
  -  Patients who was considered inappropriate to participate in the trials by the researchers.

Relevance to patient case: not relevant