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: Study of Tremelimumab in Patients With Advanced Solid Tumors

Summary: A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors

Detailed description: This is an open-label, multi-center study to determine the efficacy and safety of tremelimumab in the treatment of different cohorts of patients with selected advanced solid tumors. If eligible and at the discretion of the Investigator, after confirmed disease progression on tremelimumab monotherapy or during follow-up, patients will have the option of being sequenced to MEDI4736 (MedImmune 4736) monotherapy or MEDI4736 + tremelimumab combination therapy, for up to 12 months or until disease progression, whichever comes sooner.

Eligibility: Inclusion Criteria:
  1. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements.
  Exclusion criteria:
  1. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient

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: Phase 1 Combination Study of MM-151 and MM-121

Summary: This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121 at varying dose levels.

Detailed description: This is a two-part Phase 1, non-randomized, open-label study of MM-151 plus MM-121 in patients with advanced, heregulin-positive lung, head and neck, and colorectal cancers. In part 1 of the study cohorts of 3 or more patients will be treated at escalating doses of MM-151 in combination with MM-121 until a maximum tolerated combination dose is identified. In part 2 of the study, patients with be treated with combination dose identified in part 1 of the study.

Eligibility: Inclusion Criteria:
  -  Patients must be >18 years of age
  -  Patients must be able to provide informed consent
  -  Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of any study therapy). This applies to women of childbearing potential as well as fertile men and their partners
  -  Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy, up to CTCAE grade 1
  -  Patients must have heregulin-positive cancer
  Exclusion Criteria:
  -  Patients who are pregnant or lactating
  -  Patients who have an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled.)
  -  Patients with untreated (primary) or symptomatic CNS (primary or metastatic) malignancies; patients with CNS metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial.
  -  Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.

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: Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma

Summary: A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

Detailed description: This is a Phase II, open-label, multi-center study to determine the efficacy and safety of MEDI4736 evaluated as single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on fluoropyrimidine containing or gemcitabine-containing first-line chemotherapy.This study will consist of Part A, lead-in, as well as a possible expansion Part B.

Eligibility: Inclusion Criteria: -
  1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen
  2. Eastern Cooperative Oncology Group 0 or 1
  3. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan and that is suitable for accurate repeated measurements
  Exclusion Criteria:
  1. Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
  2. History of leptomeningeal carcinomatosis
  3. Ascites requiring intervention
  4. Brain metastases or spinal cord compression.

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: Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla

Summary: Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.

Detailed description: Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).
  All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.
  All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 & 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.
  After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.
  Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.
  Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.

Eligibility: Inclusion Criteria:
  -  Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.
  -  Fitness for chemotherapy in judgement of treating physician
  -  Bilirubin < 4 (any means of biliary drainage acceptable)
  Exclusion Criteria:
  -  Medical or mental illness precluding provision of informed consent
  -  Pregnancy
  -  Active infection for which neutropenia would pose high risk of mortality

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 to Assess Clinical an Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Route Clinical Practice Treating Pancreatic Cancer

Summary: The objective of the study is to prospectively assess the use and treatment outcomes of nab-paclitaxel plus gemcitabine in pancreatic ductal adenocarcinoma in the Netherlands. Additional objectives are to monitor the incidence and reversibility of neuropathy during treatment, to assess the patient's Quality of life when treated with nab-paclitaxel/gemcitabine and to evaluate the use of resources that come with treating metastatic pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Patients over 18 years of age who understand and voluntarily sign an informed consent form.
  -  Patients treated for pancreatic adenocarcinoma.
  Exclusion Criteria:
  -  Patients currently treated for metastatic pancreatic cancer with other therapy than nab-paclitaxel plus gemcitabine
  -  Refusal to participate in the study.
  -  Women who are pregnant or breast-feeding.
  -  Hypersensitivity to the active substance or to any of the excipients.
  -  Participation in interventional trials during the period of treatment with nab-paclitaxel

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 HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies

Summary: Phase I Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Detailed description: Open label, multi-center, nonrandomized, dose escalation trial of MVT-5873 to evaluate safety and determine the MTD and recommended phase II dose of MVT-5873 both as monotherapy (Group A) and in combination with a standard of care chemotherapy (Group B) in subjects with pancreatic and other CA19-9 positive malignancies. Both groups will utilize a conventional 3+3 study design to identify the MTD and recommended phase II dose (RP2D). following determination of MTD, 10 additional subjects will be treated at the RP2D in each group. The pharmacokinetics (PK) of MVT-5873 will be determined in each Group.

Eligibility: Inclusion Criteria
  1. Signed, informed consent
  2. Age 18 or more years
  3. Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or KPS of 100% to 80%
  5. Adequate hematologic, hepatic, and renal function
  Exclusion Criteria
  1. Brain metastases unless previously treated and well controlled for at least 3 months
  2. Other known active cancer(s) likely to require treatment in the next two (2) years
  3. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  4. Fewer than 28 days from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation except for prostate cancer hormonal therapy, and treatment with MVT-5873 and MVT-2163.
  5. Major surgery other than diagnostic surgery within 28 days of Study Day 1
  6. History of anaphylactic reaction to human, or humanized, antibody
  7. Pregnant or currently breast-feeding
  8. Known HIV-positive or Hepatitis C
  9. Psychiatric illness/social situations that would interfere with compliance with study requirements
  10. Significant cardiovascular risk including, but not limited to, recent (within 4 weeks) coronary stenting or myocardial infarction within 6 months

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: EVIS - Ex-vivo Assessment of T-lymphocyte Homing in Primary Pancreatic Cancer

Summary: This is a single-centre, prospective, non-randomised research study. The research team will investigate the feasibility of assessing primary human pancreatic tissue for changes to T lymphocyte function and localisation in the presence and absence of AMD3100.

Detailed description: Pancreatic cancer is the fourth leading cause of cancer-related deaths in Western countries. It is a lethal disease that typically presents late, metastasises early and is resistant to conventional treatments such as radiation and chemotherapy. In 2012 there were 8700 deaths in the UK from pancreatic cancer, making it the fifth most common cause of cancer-related death.
  Current therapeutic strategies are aimed at extending survival as well as improving symptoms and quality of life, but although conventional chemotherapeutic agents have achieved modest clinical benefit, the need for novel therapies is great.
  This study proposes to extend our pre-clinical studies to develop an ex-vivo assay for the assessment of AMD3100 effectiveness in human samples.
  The research team will investigate the feasibility of assessing primary human pancreatic tissue for changes to T lymphocyte function and localisation in the presence and absence of AMD3100 through obtaining a blood sample and fresh pancreatic tissue intra-operatively from pancreatic tumours located in the head of the pancreas.

Eligibility: Inclusion Criteria:
  -  Patients with primary pancreatic adenocarcinoma who are undergoing pancreaticoduodenectomy (Whipple's) resection.
  -  Patients who are over 18 years of age at the time of signing the informed consent form and who are physically and mentally capable of consenting.
  -  Willing and able to comply with study procedures.
  Exclusion Criteria:
  • Any condition or abnormalities that in the judgment of the investigator/surgeon/ histopathologist would place the patient at undue risk.

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 PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Summary: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). Participants will be randomized in a 2:1 ratio to PAG or AG treatment.


Eligibility: 1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
  2. Stage IV pancreatic ductal adenocarcinoma (PDA) with histological confirmation of PDA via archived or fresh core biopsy of either the primary tumor or 1 metastatic site.
  3. Participants must be determined to be hyaluronan-high based on tumor biopsy that meets the requirements noted in the previous inclusion criterion.
  4. At least 1 tumor metastasis measurable on computed tomography (CT) scan per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.
  5. If a participant has had adjuvant therapy (chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of adjuvant therapy, provided all toxicities have returned to baseline or ≤ Grade 1.
  6. Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  Exclusion criteria:
  1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period.
  2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
  a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.
  3. Known central nervous system involvement or brain metastases.
  4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
  5. History of cerebrovascular accident or transient ischemic attack.
  6. Pre-existing carotid artery 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: Study of Changes and Characteristics of Genes in Patients With Pancreatic Cancer for Better Treatment Selection

Summary: Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.


Eligibility: Inclusion Criteria:
  -  Patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with borderline resectable disease are not eligible.
  -  Patient must have a tumor lesion that is amenable to a core needle biopsy.
  -  Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
  -  Patients must be fit enough to safely undergo a tumor biopsy.
  -  Age 18 years or older.
  -  Eastern Cooperative Group (ECOG) performance status of 1 or less.
  -  Life expectancy of greater than 90 days.
  -  Patients must have normal organ and marrow function
  -  Patients must undergo systemic treatment with m-FOLFIRINOX or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-FOLFIRINOX or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment.
  -  Ability to understand and willing to sign a written informed consent document.
  Exclusion Criteria:
  -  Patients with one or more contraindications to tumor biopsy.
  -  Patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting.
  -  Patients who are currently on anti-cancer treatment including chemotherapy.
  -  Patients with known brain metastases.
  -  Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting.
  -  Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  -  Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

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: Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes

Summary: Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.

Detailed description: Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.
  -  Subject should start treatment no later than 10 weeks postsurgery.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Acceptable hematology parameters:
  -  Absolute neutrophil count ≥1500 cell/mm3
  -  Platelet count ≥100,000/mm3
  -  Hemoglobin (Hgb) ≥8.0 g/dL
  -  Acceptable blood chemistry levels:
  -  Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × upper limit of normal range (ULN)
  -  Total bilirubin ≤ 2.5 x upper Limit of Normal (ULN)
  -  Serum creatinine within upper limits of normal.
  -  Cancer antigen (CA)19-9 ≤ 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.
  -  No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.
  -  Signed informed consent.
  Exclusion Criteria:
  -  R2 resection or presence of metastatic disease.
  -  Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
  -  Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
  -  Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
  -  Severe, active co-morbidity, defined as follows:
  -  Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  -  Transmural myocardial infarction within the 6 months of study registration
  -  Uncontrolled hypertension, diabetes or arrhythmia.
  -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
  -  Not able to take medicine orally.

Relevance to patient case: not relevant