araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients

Summary: Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia. In this study, the investigators tried to show the effect of "Oncothermia" which is more selective to malignant tissue than conventional hyperthermia for pain control, increasing quality of life, and anti-tumor treatment.


Eligibility: Inclusion Criteria:
  -  Inoperable or recurred pancreatic ductal adenocarcinoma
  -  After the each cycle of chemotherapy, the disease status was "stable disease"
  Exclusion Criteria:
  -  Person who has an experience of hyperthermia treatment
  -  Person who has a difficulty of sensing heat
  -  Person who has a skin graft or breast reconstruction surgery
  -  Person who has a cardiac pacemaker or an implanted metal
  -  Pregnant or breast feeding women
  -  Person with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months
  -  Person who was treated with unproved drugs within 6 months
  -  Person who have a serious disease which can affect the person's safety
  -  Person who do not consent to the study

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Comparison Between Base and Cover Slide From Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer

Summary: The purpose of this study is to determine whether there is a difference of diagnostic accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients who were previously suspected of pancreatic cancer in radiologic test.

Detailed description: 1. background
  1. Pancreatic cancer is the challenging malignancy in diagnosis and treatment.
  2. Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer.
  3. Samples from EUS-FNA are sent to following three types of preparations.
  -  cytologic smear (by pull apart method)
  -  cell block
  -  histologic biopsy
  4. In cytologic smear method, endoscopists tend to send as many as slides, while pathologists want minimal slides if they warrant diagnostic accuracy.
  5. Therefore we are going to find a point of contact between high diagnostic yield and minimal overloading of pathologist.
  2. Method
  1. We are going to enrolled the patients who were suspected of pancreatic cancer in previous radiologic test.
  2. One identical and skilled endoscopist performs EUS-FNA with multiple punctures.
  3. We get total 8 pairs of slides (= 8 covers + 8 bases).
  4. All the cover slides are collected to the bottle-A, all the base slide to the bottle-B.
  5. One identical and skilled pathologist inspects these slide in blind method. (She cannot show the label of bottle so that she does not know what bottle is A or B.)
  6. She record the positive or negative in each bottle. (If there is only one slide is positive in malignant cell, the bottle is positive.)
  7. In these manner, we collect the all subjects' cytopathologic results as a pair of outcome. All the possible combinations are following four examples:
  -  (cover/base) = (positive/positive) = (+/+)
  -  (cover/base) = (positive/negative) = (+/-)
  -  (cover/base) = (negative/positive) = (-/+)
  -  (cover/base) = (negative/negative) = (-/-)
  8. Then we are going to take a two-sided non-inferiority test of proportion using McNemar's test.

Eligibility: Inclusion Criteria:
  -  patients who were suspected of pancreatic cancer in previous radiologic test such as computed tomography, magnetic resonance imaging or Positron Emission Tomography.
  Exclusion Criteria:
  -  failed smear due to inexperienced assistant
  -  loss of slide
  -  patients who were diagnosed with other lesion far from pancreatic cancer in prospective confirmative tests.
  -  patients who refuse to participate in this study
  -  report of other pathologist who are not a previously-assigned pathologist

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: A Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer

Summary: This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019 administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.

Detailed description: Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days). Tumor tissue will be collected during resection for biomarker analysis. EUS core tumor biopsies will be collected pre/post treatment at participating centers. Tumor response will be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines.
  Subjects who complete 6 cycles of treatment will be evaluated for surgical exploration for possible R0 resection. Subjects who undergo surgery will be evaluated for surgical complications for an additional 30 days following discharge from surgery. All subjects will be followed for safety for 28 days following their last dose with study drug. Blood samples will be collected periodically for the assessment of pharmacokinetics (PK) and pharmacodynamics (PD).
  All subjects, including those who discontinue from the study during the treatment period without evidence of disease progression, will be followed for at least 28 weeks post End of Treatment for disease progression, survival, and follow-on treatment for pancreatic cancer.

Eligibility: Key Inclusion Criteria:
  -  Male or non-pregnant, non-lactating female
  -  Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
  -  Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per NCCN criteria)
  -  Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted
  -  Measurable disease as defined by RECIST 1.1
  -  ECOG performance status 0 or 1
  -  Adequate liver, bone marrow and renal function
  -  Agree to use contraception per protocol
  -  Less than Grade 2 pre-existing peripheral neuropathy
  Key Exclusion Criteria:
  -  Prior chemotherapy or radiation for pancreatic cancer
  -  Solid tumor contact with SMA > 180°
  -  Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer or in situ carcinoma of the cervix)
  -  Major surgery within 4 weeks prior to Day 1 study
  -  History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
  -  Exposure to another investigational drug within 42 days of first dosing visit, or 5 half-lives of the study product (whichever is longer)
  -  Uncontrolled intercurrent illness
  -  Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
  -  Current abuse of alcohol or drugs

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Summary: This study will evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma.


Eligibility: Key Inclusion Criteria:
  -  Relapsed or refractory metastatic pancreatic adenocarcinoma
  -  Received 1 prior chemotherapy regimen for metastatic pancreatic ductal adenocarcinoma (not including neoadjuvant and/or adjuvant therapy)
  -  Measurable disease per RECIST v1.1
  -  Adequate organ function defined as
  -  Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN) OR ≤ 5 x ULN if liver metastases are present; total conjugated bilirubin ≤ 2 x ULN
  -  Absolute neutrophil count (ANC) ≥1500 cells/mm^3, platelet ≥100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dL
  -  Creatinine clearance (CrCl) > 50 ml/min as calculated by the Cockroft-Gault method
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  Key Exclusion Criteria:
  -  Received more than 1 prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma
  -  Major surgery within 21 days of first dose of study drug
  -  Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable)
  -  Chemotherapy, immunotherapy, biologics, and/or investigational therapy within 21 days prior to first dose of study drug
  -  Known positive status for HIV, chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier
  -  Known dihydropyrimidine dehydrogenase deficiency
  -  Peripheral neuropathy ≥ Grade 2
  -  Any condition that impairs gastrointestinal absorption of drug
  -  Known or suspected brain or central nervous system metastases
  -  Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma
  -  External biliary drain
  -  Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment
  Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma

Summary: This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma.
  The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.


Eligibility: Inclusion Criteria:
  1. Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
  2. Availability of FFPE tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization.
  3. Age ≥21 years
  4. ECOG performance status 0 or 1 5. Measurable disease per RECIST v1.1
  5. Adequate organ and marrow function
  6. Signed Informed Consent Form
  7. For women of childbearing potential, agreement to use two effective forms of contraception
  Exclusion Criteria:
  1. Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
  2. Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
  3. Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
  4. Subjects with Grade >2 peripheral neuropathy
  5. Subjects with clinically significant ascites
  6. Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
  7. Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
  8. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
  9. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
  10. Pregnant women or nursing women
  11. Subjects with known HIV infection
  12. Known bleeding disorder or coagulopathy

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling

Summary: Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology and/or fine needle biopsy (FNB) for histology may be used in the diagnostic work-up of intrathoracic and intrabdominal lesion of unknown origin. Certain lesions (such as pancreatic adenocarcinoma) are often well characterized by cytology assessment of FNA-samples while others are not (such as GIST-tumors).
  This study is a part observational (early study phase) and part interventional study (late study phase) on the diagnostic accuracy of EUS-assisted tissue sampling by FNA or FNB during a 10-year period on a tertiary endoscopy centre.

Detailed description: Variables affecting the diagnostic accuracy of EUS-FNA and EUS-FNB in different cases and tumor scenarios will be studied in detail such as the influence of medical equipment used (i.e the different types and sizes of puncture needles), the experience of the endosonographers, cytopathologists and pathologists and the use of rapid on-site evaluation of cytology samples.
  Each study case is reviewed post-EUS (according to the schedule precised below) regarding further diagnostic work-up, neoadjuvant treatment, surgery result, clinical follow-up, (neo)adjuvant treatment, and survival. Non-parametrical tests will be applied as the main statistical method.

Eligibility: Inclusion Criteria:
  -  Referral for a diagnostic EUS
  Exclusion Criteria:
  -  Referral for an interventional EUS

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients

Summary: The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population.


Eligibility: Inclusion Criteria:
  -  Surgeon trained in and performing the HIPEC procedure
  Exclusion Criteria:
  -  Not performing the HIPEC procedure

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC

Summary: The purpose of this study is to determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone in regards to OS in patients with heregulin-positive NSCLC.

Detailed description: This study is a randomized, open-label, international, multi-center, phase 2 study in patients with Heregulin-positive NSCLC that have progressed following no more than three systemic therapies for locally advanced or metastatic disease, of which one must have been an anti-PD-1 or anti-PD-L1 therapy. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with investigator's choice of either docetaxel or pemetrexed versus docetaxel or pemetrexed alone.

Eligibility: Inclusion Criteria:
  -  Patients with a diagnosis of cytologically or histologically confirmed NSCLC with either metastatic disease (stage IV) or Stage IIIB disease not amenable to surgery with curative intent
  -  Failed an anti-PD-1 or anti-PD-L1 therapy and has not received more than 3 prior systemic therapies for primary or recurrent disease
  -  Tissue submitted for HRG-biomarker testing
  -  ECOG performance status (PS) of 0 or 1
  Exclusion Criteria:
  -  Known ALK mutation
  -  Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene
  -  Received >3 prior systemic anti-cancer drug regimen for locally advanced disease
  -  Prior treatment with an anti-ErbB3 antibody
  -  CTCAE grade 3 or higher peripheral neuropathy
  -  Symptomatic CNS metastases or CNS metastases requiring steroids
  -  Any other active malignancy requiring systemic therapy
  -  Clinically significant cardiac disease

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Modified FOLFIRINOX for Gemcitabine Refractory Pancreatic Cancer: A Phase II Multicenter Trial

Summary: Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for advanced pancreatic patients, no drug or combination of drugs has significantly improved the prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies, modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved safety profile in digestive malignancies. The purpose of this phase II multicenter study was to investigate the efficacy and safety in patients with pancreatic cancer who progressed in gemcitabine-based first line chemotherapy.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)
  -  Refractory or progress to Gemcitabine based 1st line chemotherapy
  -  Older than 19 years old and younger than 75 years old
  -  Life expectancy> 3 months
  -  ECOG Performance status ≤2
  -  Only patients with measurable lesions in imaging study
  -  Adequete BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
  -  Adequete liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)
  -  Adequete renal function (serum creatinine < 1.5 mg/dl)
  -  Adequete cardiopulmonary function
  Exclusion Criteria:
  -  Pathologically confirmed another type of pancreatic cancer (except ductal adenocarcinoma)
  -  Metastatic adenocarcinoma of originating at other organs
  -  Evidence with CNS metastasis
  -  Active infection
  -  Uncontrolled serious medical or psychiatric illness which can induce toxicity ro complication of treatment, such as inability to swallow, lacking physical integrity of the gastrointestinal tract, malabsorption syndrome, or active ulceration at upper gastrointestinal tract.
  -  Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin
  -  Participation in any other investigational drug study within 1 month
  -  No signed informed consent

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors

Summary: The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.

Detailed description: This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. This study is designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK profile of KBP-5209.

Eligibility: Inclusion Criteria:
  -  Age 18 years or older;
  -  Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists.
  -  Patients must have at least one measurable or non-measurable lesion (dose escalation only) as defined by RECIST v1.1
  -  Eastern Cooperative Oncology Group performance score 0 to 2;
  Exclusion Criteria:
  -  Patients with symptomatic CNS metastases;
  -  Patients who have a known history of hepatitis C or chronic active hepatitis B or a known diagnosis of HIV
  -  Any significant ophthalmologic abnormality
  -  Patients who have any severe and/or uncontrolled medical conditions
  -  Significant gastrointestinal abnormalities,
  -  Patients who have impaired cardiac function or clinically significant cardiac diseases,
  -  Chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study drug on Day 1 or have not recovered from the side effects of such therapy;
  -  Treatment with third generation EGFR inhibitors
  -  Major surgery/surgical therapy for any cause within 4 weeks of Screening;

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: According CTC to Compare the Influences of Different Methods to Remove the PDAC

Summary: Acccording circulating tumor cells to compare the differences of different methods(routine method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of pancreatic body and tail.


Eligibility: Inclusion Criteria:
  -  Ductal adenocarcinoma of pancreatic body and tail
  -  Tumor can be removed
  -  No other tumors and without liver metastases
  -  Age from 18 to 80 years old
  Exclusion Criteria:
  -  Neoplasms with other sites of the pancreas
  -  With other tumors of any other sites

Relevance to patient case: not relevant