araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma.

Summary: This study will assess if endoscopic ultrasound radiofrequency application in patients with inoperable pancreatic cancer and chemotherapy confers survival benefit when compared to patients receiving best medical care and chemotherapy .

Detailed description: Prospective randomised clinical study in patients with adenocarcinoma of the pancreas.
  Patients will be randomised 1:1. Patients in the treatment group will receive standard chemotherapy plus 3 radiofrequency ablation procedures, each one month apart.
  Patients in the control group will receive standard chemotherapy and best medical care.

Eligibility: Inclusion Criteria:
  -  Patients above 18 years of age
  -  A cytological/ histological diagnosis of inoperable PDAC based on multidisciplinary review of cross-sectional imaging and cytology/ histology results.
  -  Patients who have been deemed unfit for surgical resection of the PDAC; subjects who are fit for surgical resection, but have declined surgery will also be considered for the study
  -  PDAC patients presenting with jaundice to be considered after a successful biliary drainage (bilirubin <50umol/L)
  -  Patients ought to be fit enough to be considered for the study (ECOG performance status 0, 1 or 2)
  -  Patients who have commenced chemotherapy are not excluded from the study
  -  Patients capable of giving informed consent
  -  Negative blood pregnancy test for women of childbearing potential
  -  Willingness and ability to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures.
  Exclusion Criteria:
  -  ECOG performance status 3 or 4
  -  Life expectancy less than 3 months
  -  Prior investigational drugs within the last 30 days
  -  Grade > 1 treatment-related toxicities (excluding alopaecia) at the time of screening
  -  Patients with clinically significant cancer ascites
  -  Known infection with human immunodeficiency virus (HIV)
  -  Patient with central nervous system (CNS) metastasis
  -  Major surgery within the last 30 days
  -  Patients with sepsis, obstructive jaundice or encephalopathy
  -  Evidence of spontaneous bacterial peritonitis or renal failure
  -  Pregnant or lactating women
  -  Any other condition (e.g., known or suspected poor compliance, etc.) that, in the judgment of the investigator, may affect the participant's ability to follow the protocol specific procedure

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Trial of NanoPac in Subjects With Locally Advanced Pancreatic Adenocarcinoma

Summary: Open-label, dose-escalating, Phase IIa trial of NanoPac to treat subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas via direct intratumoral injection.

Detailed description: In this open-label, dose-escalating, Phase IIa trial, subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas will receive intratumoral (ITU) NanoPac (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
  Subjects will be enrolled in sequential cohorts of NanoPac at escalating doses, at a volume based on up to 20% of calculated tumor volume (with a maximum injection volume of 5 mL per subject). Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling, an additional three subjects at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted.
  The dose determined to be most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the Data Safety Monitoring Board (DSMB), will enroll additional subjects to provide a cohort of up to 12 subjects at that dose level.
  Plasma samples will be taken at various time points on the day of NanoPac injection as well as once at each of the study visits, to characterize the pharmacokinetics (PK) of intratumoral NanoPac.
  Subjects will be followed for three months after NanoPac injection for safety, overall survival (OS), progression-free survival (PFS), CA-19-9 levels, carcinoembryonic antigen (CEA) levels, reduction in pain, and tumor response to therapy (as shown by imaging). A follow-up visit may be conducted at six months, as applicable.

Eligibility: Inclusion Criteria:
  -  Signed informed consent;
  -  Age 18 to 75 years;
  -  Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; located in the tail or body of the pancreas with a diameter of at least 2 cm but no more than 4cm;
  -  Performance Status (ECOG) 0-1 at study entry; Life expectancy of at least 3 months;
  -  Adequate marrow, liver, and renal function; Platelet count ≥ 75 x 109/L and ANC ≥ 1.5 x 109/L;
  -  Effective contraception if the risk of conception exists.
  Exclusion Criteria:
  -  Prior radiation therapy for pancreatic cancer;
  -  Thrombotic or embolic events;
  -  Acute or subacute intestinal occlusion; History of inflammatory bowel disease;
  -  Known hypersensitivity to study drugs; Known drug or alcohol abuse;
  -  Pregnant or breastfeeding women;
  -  Previous or concurrent history of non-pancreatic malignancy except for metastatic pancreatic disease or non-melanoma skin cancer.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Summary: Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.

Detailed description: Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.

Eligibility: Inclusion Criteria:
  -  ≥ 18 years if age
  -  Diagnosed with stage III pancreatic cancer
  -  Tumor is measurable
  -  Glomerular Filtration Rate > 60 m/L/min/1.73 m(2)
  -  Willing and able to comply with the protocol requirements
  -  Able to comprehend and have signed the informed consent to participate
  Exclusion Criteria:
  -  Participating in another clinical trial for the treatment of cancer at time of screening
  -  Are pregnant or currently breast feeding
  -  Have a cardiac pacemaker or Implantable Cardioverter Defibrillator implanted that cannot be deactivated during the procedure
  -  Have non-removable implants with metal parts within 1 cm of the target lesion
  -  Had a myocardial infarction within 3 months prior to enrollment

Relevance to patient case: not relevant