araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

Summary: This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with Fibroblast Growth Factor receptor (FGFR) genetic alterations.

Detailed description: Adult patients with histologically or cytologically confirmed advanced or metastatic cholangiocarcinoma with FGFR genetic alterations who have evidence of radiologic progression following a cisplatin-and gemcitabine-containing regimen for advanced disease or a gemcitabine-containing regimen for those who are considered intolerant to cisplatin will be enrolled. Approximately 55 adult patients over age 18, both male and female will be enrolled. Of these 55 patients, 40 patients will have cholangiocarcinoma with identified FGFR2 gene fusions and up to 15 patients may have other FGFR genetic alterations. All patients will receive oral BGJ398, once daily, on a three weeks on (21 days), one week off (7 days) schedule. One treatment cycle will consists of 28 days.

Eligibility: Inclusion criteria:
  - Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis.
  Patients with cancers of the gallbladder or ampulla of Vater are not eligible.
  - Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease.
  Exclusion criteria:
  -  Prior or current treatment with a MEK or selective FGFR inhibitor
  -  insufficient organ function
  -  Absolutely Neutrophil Count (ANC) < 1,000/mm3 [1.0 x 109/L]
  -  Platelets < 75,000/mm3 [75 x 109/L]
  -  Hemoglobin < 109.0 g/dL
  -  Total bilirubin > 1.5x ULN
  -  Aspartate aminotransferase/glutamic oxaloacetic transaminase/GOT (AST/SGOT) and Alanine aminotransferase/glutamic pyruvic transaminase/GPT (ALT/SGPT) > 2.5x ULN (AST and ALT) > 5x upper limit of normal (ULN) in the presence of liver metastases)
  -  Serum creatinine > 1.5x ULN and a calculated or measured creatinine clearance < 45 mL/min
  -  Inorganic phosphorus outside of normal limits
  -  Total and ionized serum calcium outside of normal limits
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: Copanlisib Pharmacodynamic Study

Summary: This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.


Eligibility: -  Histologically confirmed diagnosis of the following NHL: follicular lymphoma all grades, lymphoplasmacytic lymphoma / Waldenström macroglobulinemia, transformed indolent lymphoma, diffuse large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma, or peripheral T-cell lymphoma, relapsed or refractory, with 1 or more prior chemo-immunotherapy- or immunotherapy-based regimen(s) OR
  -  Advanced and / or refractory solid tumors with high prevalence (≥30%) of PIK3CA or PTEN alteration: Breast and uterine cancers (endometrium cancers but also non-endometrial uterine cancers), lung (squamous cell only), cervical, head and neck, prostate, and ovarian cancers
  -  Biopsy-accessible tumor
  -  Male or female patients equal 18 or more years of age
  -  NHL patients must have at least 1 bi-dimensionally measurable lesion according to the modified Cheson criteria. Patients with solid tumors must have at least 1 solid tumor lesion measurable by computed tomography or magnetic resonance imaging according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria
  -  Eastern Cooperative Oncology Group performance status 2 or <
  -  Life expectancy of at least 3 months
  -  Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements conducted within 7 days before the first dose of study drug
  -  Left ventricular ejection fraction > or equal the lower limit of normal for the institution
  Exclusion Criteria:
  -  Previous or concurrent cancer that is distinct in primary site or histology from NHL or the solid tumor, for which the patient is enrolled into this study, within 5 years before treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, in situ breast cancer, in situ prostate carcinoma if Gleason score < or equal to 6 and prostate-specific antigen <10 ng/mL, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]
  -  Known lymphomatous involvement of the brain or leptomeningeal involvement; solid tumor patients with central nervous system (CNS) metastases if treatment completed <3 months before enrollment or lesions unstable or progressing on magnetic resonance imaging scans performed within 1 month of enrollment or unstable symptoms of the CNS metastases
  -  Any illness or medical condition that is unstable or could jeopardize the safety of the patient or his / her compliance in the study
  -  Current diagnosis of type 1 or type 2 diabetes mellitus with HbA1c < or equal to 8.5% or fasting blood glucose < or equal to 160 mg/dL

Relevance to patient case: possibly relevant
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: Treatment for Bile Duct Cancer in the Liver

Summary: The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic cholangiocarcinoma. This study aims to study the benefits of sequential administration of SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic cholangiocarcinoma.


Eligibility: Inclusion Criteria:
  -  Age>18 years
  -  Histological or cytological diagnosis of cholangiocarcinoma
  -  Disease not amenable to surgery
  -  Predominant disease load in the liver (in case of extra-hepatic involvement, only patients with lymph nodes metastases are allowed)
  -  Naïve to locoregional or systemic treatment (but patients who develop recurrent disease after surgery are suitable)
  -  ECOG PS 0-1
  -  At least one measurable disease lesion according to RECIST v 1.1
  -  Life expectancy of 12 weeks or longer
  -  Adequate hematological, renal and hepatic function
  -  Platelet ≥100 x 109
  -  ANC ≥ 1.5 x 109
  -  Bilirubin ≤ 30µmol/L
  -  Albumin ≥ 30g/L
  -  ALT ≤ 3 ULN
  -  INR ≤ 1.5
  -  Serum creatinine ≤ 1.5 x ULN
  Exclusion Criteria:
  -  Prior malignancy except cervical carcinoma-in-situ or treated basal cell carcinoma. Any cancers treated curatively > 5 years prior to study entry are permitted.
  -  Patients with extra-hepatic disease other than regional lymph node metastases.
  -  Evidence of ascites or cirrhosis, as determined by clinical or radiologic assessment
  -  Biliary obstruction with no possibility of drainage
  -  Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
  -  Prior treatment of chemotherapy for the cholangiocarcinoma
  -  Prior radiation therapy to the upper abdomen
  -  Complete thrombosis of the main portal vein
  -  Tumor volume > 50% of the normal liver volume
  -  Allergy to non-ionic contrast agents

Relevance to patient case: not relevant
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: The Oncopanel Pilot (TOP) Study

Summary: The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes.
  The purpose of this pilot study is to assess the feasibility and effect on clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being considered for clinical trials.

Detailed description: Somatic mutations in solid tumors represent an established means of characterizing malignancies for prognostic, diagnostic and therapeutic purposes. Mutations in EGFR, KRAS, BRAF, and KIT and PDGFRA genes direct therapy in patients with advanced lung, colorectal, melanoma, and GIST tumors, respectively. Known or novel mutations in other genes may also be of clinical significance but are not identified by current genotyping offered to BC Cancer Agency (BCCA) patients. Furthermore, numerous candidate genes have been implicated as potential prognostic and predictive biomarkers in patients with solid tumours. As such, the Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes. The following clinically relevant set of genes and exons are included in the Oncpanel: KRAS, EGFR, BRAF, NRAS and HRAS, PIK3CA Signal Transduction Pathway Genes, RAS-RAF-MEK-MAPK Pathway, HER2, IDH1 and IDH2, ALK, TP53, c-KIT, STAT1&3 and PDGFRA. Additional testing on the tumour material will also include analysis of specific gene variants associated with adverse events or response to therapy.
  Numerous studies have documented the presence of circulating tumour DNA (ctDNA) among patients with advanced and early stage malignancies (20-22). The ability to diagnose standard cancer mutations with a blood-based assay (a "liquid biopsy") has not yet been established but presents obvious advantages. The emergence of "resistance" mutations arising in the metastatic tumor or throughout the course of therapy is well documented (21, 22). A blood biopsy may represent more accurate determination of the tumor's genetic features than archival DNA specimen. Adequate tissue specimens can be difficult to obtain from some patients with diagnosed malignancies, particularly lung cancer. A blood biopsy may represent a less invasive and timelier means of diagnosing both standard and translational cancer mutations.

Eligibility: Patients with archival tumor tissue and a known history of invasive malignancies are eligible if they meet one or more of the following criteria:
  -  Advanced colorectal cancer and eligible for standard KRAS testing,
  -  Advanced non-small cell lung cancer and eligible for standard EGFR testing,
  -  Advanced melanoma and eligible for standard BRAF testing,
  -  Gastrointestinal stromal tumors (GISTs) eligible for standard c-KIT and PDGFRA testing,
  -  Being considered for potential eligibility in clinical trial.

Relevance to patient case: possibly relevant
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: Lapatinib Plus Trametinib in KRAS Mutant NSCLC

Summary: This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.


Eligibility: Inclusion Criteria:
  -  Histological or cytological proof of metastatic NSCLC; for PART B: treated with first line therapy for metastatic disease only.
  -  Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wild-type (exon 9 and 20)
  -  Age ≥ 18 years
  -  Able and willing to give written informed consent
  -  WHO performance status of 0 or 1 (part A and B)
  Exclusion Criteria:
  -  Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
  -  History of another primary malignancy
  -  Symptomatic or untreated leptomeningeal disease
  -  Symptomatic brain metastasis
  -  History of interstitial lung disease or pneumonitis
  -  Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
  -  Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment
  -  Patients with left ventricular ejection fraction (LVEF) < 50%

Relevance to patient case: not relevant
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Summary: The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

Detailed description: Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.

Eligibility: Inclusion Criteria:
  -  Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma)
  -  Patients aged between 18 and 80 years
  -  an estimated life expectancy of more than 3 months
  -  Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria
  -  TNM stage III-IV
  -  no evidence of cancer of another organ.
  -  no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed
  -  Karnofsky index of ≥60%
  -  ECOG index ≥2
  -  previous technically successful stenting or ENBD derange
  -  Accept of informed consent
  Exclusion Criteria:
  -  Clinically significant cardiovascular disease
  -  coagulation disorders
  -  contraindication of Endoscopic
  -  pregnant or breastfeeding women
  -  known sensitivity sensitivity to investigated agents or components
  -  recent invasive procedure
  -  prior chemotherapy or radiotherapy for biliary cancer
  -  refusal of informed consent

Relevance to patient case: not relevant
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Summary: The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.
  Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.


Eligibility: Inclusion Criteria:
  -  patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
  -  Patients with epidermoid cancer of the lungs can benefit from chemotherapy
  -  man and women
  -  age ≥ 18 years
  -  Patients have signed a written informed consent form
  -  Patients are affiliated to s social health insurance
  Exclusion Criteria:
  -  Survival time ≤ 3 months
  -  Patients with cerebral metastases
  -  Patients could not benefit from treatment for others diseases
  -  Pregnancy or breast-feeding
  -  Incapacity to sign the consent form for psychiatric, behavioural disorders
  -  Private individuals of freedom or under tutelage

Relevance to patient case: not relevant
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)

Summary: To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi.

Detailed description: This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib (IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.

Eligibility: Inclusion Criteria:
  -  ≥18 years of age
  -  Diagnosis of Chronic lymphocytic leukemia or Small lymphocytic lymphoma that meets at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for treatment (Binet Stage ≥ B and/or Rai Stage ≥ I with symptoms)
  -  Measurable disease with a lymph node or tumor mass >1.5 cm in at least one dimension as assessed by computed tomography (CT)
  -  Previous exposure to BTKi therapy and meets at least one of the below criteria:
  -  Progressive disease while receiving a BTKi therapy, or stable disease as best response after 12 months of receiving a BTKi therapy
  -  Discontinued a BTKi therapy due to BTKi treatment-related intolerance
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (corresponds to Karnofsky Performance Status [KPS] ≥60%)
  -  Subjects must be able to receive outpatient treatment and laboratory monitoring (where specifically indicated) at the institution that administers study drug for the entire treatment period
  Exclusion Criteria:
  -  Richter's transformation or prolymphocytic leukemia
  -  Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing regimen)
  -  Progressive disease while previously receiving a PI3K inhibitor (e.g. GS-1101 [idelalisib], duvelisib) or a serious/severe AE related to PI3K inhibitor treatment
  -  History of severe reaction to prior monoclonal antibody therapy (defined as a Grade 4 event and/or requiring permanent discontinuation)
  -  Human immunodeficiency virus (HIV) or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
  -  Prior, current, or chronic hepatitis B or hepatitis C infection
  -  History of tuberculosis treatment within the preceding 2 years

Relevance to patient case: not relevant
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: Effects of WB-EMS and Dietetic Treatment on Cancer Patients

Summary: This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment


Eligibility: Inclusion Criteria:
  -  malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation
  -  ongoing or planned curative or palliative anti-cancer therapy
  Exclusion Criteria:
  -  simultaneous participation in other nutritional or exercise intervention trials
  -  acute cardiovascular events
  -  use of anabolic medications
  -  epilepsy
  -  severe neurological diseases
  -  skin lesions in the area of electrodes
  -  energy active metals in body
  -  pregnancy
  -  acute vein thrombosis

Relevance to patient case: not relevant
Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

Clinical trial: Study of Efficacy of CDZ173 in Patients With APDS/PASLI

Summary: This study is designed to explore CDZ173, a selective PI3Kδ inhibitor, in patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI. The study consists of two parts. Part I is the open label part designed to establish the safety and pharmacokinetics of CDZ173 in the target population, as well as to select the optimal dose to be tested in part II. Part II is designed to assess efficacy and safety of CDZ173 in this population.

Detailed description: This study is designed to explore CDZ173, a selective PI3Kδ inhibitor, in patients with genetically activated PI3Kδ, i.e., patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/ p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)I.
  The study consists of two parts. Part I is the open label part designed to establish the safety and pharmacokinetics of CDZ173 in the target population, as well as to select the optimal dose to be tested in part II.
  Part II is designed to assess efficacy and safety of CDZ173 in this population.

Eligibility: Key Inclusion Criteria:
  -  patients who have a documented APDS/PASLI-associated genetic PI3K delta mutation
  -  In Part I and Part II, patients must have nodal and/or extranodal lymphoproliferation, and clinical findings and manifestations compatible with APDS/PASLI such as a history of repeated oto-sino-pulmonary infections and/or organ dysfunction (e.g., lung, liver). Additionally, in part II, patients must have at least one measurable nodal lesion on a CT or MRI scan.
  Key Exclusion Criteria:
  -  Any medically significant disease or condition that is unrelated to APDS/PASLI
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant