araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Summary: Although anti-HER2 (human epidermal growth factor receptor 2) therapy is currently approved for breast, gastric, and gastroesophageal cancers overexpressing the HER2 protein or amplified for the HER2 gene, HER2 aberrations (gene amplification, gene mutations, and protein overexpression) are reported in other diverse malignancies. Indeed, about 1-37% of tumors of the following types harbor HER2 aberrations: bladder, cervix, colon, endometrium, germ cell, glioblastoma, head and neck, liver, lung, ovarian, pancreas, and salivary duct.
  Lapatinib is an orally active, reversible, small molecule TKI that potently inhibits both ErbB1 and ErbB2 tyrosine kinase activity. Data suggest that a dual ErbB1 and ErbB2 inhibitor may provide improved therapeutic benefit compared with inhibitors that target only one or the other receptor.
  Therefore, this phase 2 study is designed to evaluated the activity of lapatinib in patients with HER2-positive refractory cancer.


Eligibility: Inclusion Criteria:
  -  Age > 19
  -  Written informed consent
  -  ECOG 0-2,
  -  Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1)
  -  Adequate organ function
  Exclusion Criteria:
  -  Uncontrolled symptomatic brain metastasis,Uncontrolled active infection
  -  Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia)
  -  Prolonged QT interval in ECG (QTc >450 msec)
  -  Pregnant, lactating women
  -  Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication
  -  Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Summary: This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2 dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221 in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal Growth Factor Receptor (EGFR).


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2.
  -  Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
  -  Has an archived, diagnostic tumor tissue available for analysis.
  -  Has adequate hematologic, renal, cardiac and hepatic function.
  -  Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
  Exclusion Criteria:
  -  Previously received an EGFR-directed monoclonal antibody within the past 4 weeks.
  -  Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events.
  -  History of major immunologic reaction to any IgG containing agent.
  -  Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.

Relevance to patient case: possibly relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer

Summary: To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.

Detailed description: Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including surgery or concurrent chemoradiotherapy. EGFR is overexposed in most of the cases. In this phase II trial, the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy will be investigated in this setting.

Eligibility: Inclusion Criteria:
  1. Pathologically confirmed esophageal carcinoma
  2. Stage I～Iva By EUS and CT/MRI, without contraindication for radical radiotherapy
  3. Aged ≥ 70 and < 85 years, behavioral status evaluation ECOG scores 0-2
  4. In 7 days after being screened, subjects should follow the status: WBC ≥ 3.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 80 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
  5. Subjects should sign for the informed consent
  6. Subjects should perform good compliance
  Exclusion Criteria:
  1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
  2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
  3. Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
  4. Patients who have multiple foci esophageal carcinomas
  5. Patients who are/were given any other medicine tests currently/in last 4 weeks
  6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
  7. Patients who have complications as following:
  (1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer

Summary: The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.


Eligibility: Inclusion Criteria:
  1. Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
  2. No previous systemic anticancer therapy.
  3. life expectancy more than three months.
  4. ECOG Performance Status of 0 to 1.
  5. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
  6. Patients will be required to provide informed consent before enrollment.
  Exclusion Criteria:
  1. Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
  2. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
  3. Severe heart disease, uncontrolled diabetes mellitus, or active infection.
  4. Active concomitant malignancy, and pregnancy or breast-feeding.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: 4D FDG PET in Esophageal Cancer

Summary: FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph nodes. The investigators hypothesize that the metabolic signal obtained with motion compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor and lymph nodes.

Detailed description: Patients will receive a normal 3D FDG PET-CT scan. By participating in this trial, one extra 4D CT scan will be made. For both the PET and the 4D CT acquisition, the patient gets an abdominal belt around the waist to register breathing motion. No extra FDG PET scan is required for this study. The 4D CT scan is the only intervention which increases the radiation dose exposure compared to the standard PET-CT scan. However, in comparison to the expected radiation dose delivered, if a patient will be treated with curative chemoradiotherapy, this increase in radiation dose is negligible and secondary risks due to this intervention are therefore not increased. For patients who are not eligible for curative treatment the extra dose is also not relevant, given the life expectancy of this group.

Eligibility: Inclusion Criteria:
  -  Patients with pathology proven esophageal cancer or tumor highly suspicious for esophageal cancer
  -  > 18 years
  -  Written informed consent
  Exclusion Criteria:
  -  <18 years
  -  Possibility of pregnancy

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy

Summary: This study will evaluate, if an intensive individually adaptated training program via online supervision during neoadjuvant therapy will improve lung function and reduce pulmonary complications following esophagectomy for Barrett's cancer.

Detailed description: Patients undergoing surgery for esophageal cancer have a high risk for postoperative deterioration of lung function and pulmonal complications. This may be partly due to one-lung ventilation during the thoracic part of the operation. This often encounters for prolonged periods of reconvalescence and reduced quality of life, apart from socioeconomic disadvantages. Physical preconditioning has become a crucial leverage to optimize fitness and lung function in patients scheduled for esophagectomy, in particular during the interval of neoadjuvant therapy.

Eligibility: Inclusion Criteria:
  -  Histologically proven adenocarcinoma of the esophagus or adenocarcinoma of the esophagogastric junction type I according to Siewert's classification, clinical stages IIB-IIIC (T3/T4 and/or N+; M0) according to Union Internationale Contre le Cancer (UICC), 7th Edition
  -  Resectable stage according to discussion in the local multidisciplinary tumor board (MDT) of the participating centers and patient medically fit for multimodality therapy (ECOG performance status at least 1 or better, no severe impairment of cardiac, renal, hepatic, endocrine, bone marrow and cerebral functions)
  -  Planned abdominal-thoracic esophagectomy with gastric pull-up and intrathoracic or cervical anastomosis
  -  Cognitive ability of the patient to understand the perioperative program and to participate actively
  Exclusion Criteria:
  -  Presence of a second malignant tumor (unless curatively treated > 5 years ago)
  -  Chemotherapy or radiochemotherapy in patient's history
  -  Orthopedic, rheumatologic, cardiovascular or neurologic (epilepsy, stroke, Parkinson's disease, muscle wasting diseases such as amyotrophic lateral sclerosis or multiple sclerosis) contraindications for the sports program
  -  Inability to use the internet or no internet Access
  -  Inability to communicate in German
  -  Each active disease, which hinders completion of the study
  -  Active alcoholism or illegal drug consumption within the last six months before study entry

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium

Summary: Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The purpose of this study is to assess the safety, feasibility and performance of cryoablation system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous dysplasia who need ablation therapy for clinical standard care. The new cryoablation treatment will be offered as an alternative to standard ablation therapies already in place (radiofrequency ablation, carbon dioxide cryotherapy).

Detailed description: Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The purpose of this study is to assess the safety, feasibility and performance of cryoablation system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous dysplasia who need ablation therapy for clinical standard care. The new cryoablation treatment will be offered as an alternative to standard ablation therapies already in place (radiofrequency ablation, carbon dioxide cryotherapy).

Eligibility: Inclusion Criteria:
  -  Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.
  Exclusion Criteria:
  -  Patient unable to undergo endoscopy,
  -  Patients with visible esophageal mass.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: MR/PET in the Evaluation of Patients With Esophageal Cancer

Summary: In this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform MR/PET before and after chemoradiation therapy. In MR, new image sequences will be added to the conventional sequences, such as high resolution image, DWI, DCE, cine imaging.

Detailed description: Total 80 patients will be recruited and followed after treatment complete for at least two years. We will compare the staging accuracy of MR/PET and PET/CT, and also analyze parameters that are predictive of disease recurrence and patient survival.

Eligibility: Inclusion Criteria:
  1. newly diagnosed esophageal cancer patient
  2. age older than 20 years
  Exclusion Criteria:
  1. For the safety reason, patients with the following conditions are contraindicated to enter magnetic resonance imaging (MRI) machine due to the high magnetic field, including: cardiac pacemaker, metallic artificial valve, intracranial and mediastinal vascular clips, cardiac defibrillator, nerve stimulator, implanted drug deliver system, metallic foreign body in the eye globe, cochlear implant, metallic fragments in the dangerous body part, Swan-Ganz catheter, and other metallic implants within 8 weeks: such as cardiac valve, stent, coil, filter, and clips.
  2. patient who will receive endoscopic local therapy alone
  3. unable to finish the standard surgical or radiation treatment
  4. history of surgery or radiotherapy to the mediastinum
  5. renal insufficiency, contraindication to MR imaging and contrast injection patient who have the severe allergic reaction the Gadollium contrast agent
  6. patient who have the claustrophobic symptoms are also not suitable for this MR examination
  7. pregnancy or lactating women

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Rociletinib (CO-1686) USA Expanded Access Program

Summary: To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC who have been treated previously with EGFR directed therapy and have evidence of a T790M mutation (T790M+).

Detailed description: This is an open-label, multi-center study in the US, which allows for expanded access to rociletinib for patients with advanced or metastatic, EGFR-mutant T790M+ NSCLC who were previously treated with at least one prior EGFR TKI therapy (≥2nd line). Patients will receive oral rociletinib twice daily on study as long as they have clinical benefit and until they have access to FDA-approved rociletinib.

Eligibility: Key Inclusion Criteria:
  -  Unresectable locally advanced or metastatic NSCLC with EGFR activating mutation (excluding exon 20 insertion) and presence of the T790M mutation
  -  Prior treatment with an approved or experimental EGFR-directed therapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  -  Adequate hematological and biological function
  -  Written informed consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF before any study-specific evaluation
  Key Exclusion Criteria:
  -  Eligibility for other enrolling clinical trials of rociletinib
  -  Leptomeningeal carcinomatosis or other untreated or symptomatic CNS metastases (asymptomatic CNS metastases allowed if clinically stable without requirement for steroid dose increase for at least 4 weeks)
  -  History of prior interstitial lung disease
  -  Concurrent use of QT-prolonging medication
  -  Cardiac abnormalities:
  -  Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) > 450 ms
  -  Inability to measure QT interval on ECG
  -  Personal or family history of long QT syndrome
  -  Implantable pacemaker or implantable cardioverter defibrillator
  -  Resting bradycardia < 55 beats/min
  -  Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism, and other active malignancy associated with life expectancy of less than 1 year)
  -  Pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for 12 weeks after the last dose of rociletinib
  -  Any contraindication, allergy, or hypersensitivity to rociletinib or excipients

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy

Summary: The investigators conducted this phase II study of EGCG therapy protection of the esophagus from damage induced by radiotherapy. In order to observe the effectiveness of EGCG, esophageal toxicity was recorded weekly using a grading scale based on symptomatology, following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain related to esophagitis was measured using the numerical rating scale (NRS) every week from EGCG application to 2 weeks after the end of radiotherapy. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.


Eligibility: Inclusion Criteria:
  -  Be required to have the seventh edition of American Joint Committee on Cancer (AJCC) stage IIIA and were considered medically inoperable, or stage IIIB.
  -  Age≥18 years
  -  Eastern Cooperative Oncology Group performance status 0-1
  -  No prior systemic chemotherapy or radiation to the thorax
  -  Adequate hematologic, hepatic function, and renal values
  -  Forced expiratory volume1 >800 cc.
  Exclusion Criteria:
  -  Pregnancy or lactation
  -  A known allergy or hypersensitivity to EGCG
  -  Patients with mediastinal tumor or metastatic lymph nodes which invade esophagus
  -  The percentages of esophagus volume receiving above 50 Gy (V50) <30%.

Relevance to patient case: not relevant
Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition

Summary: The purpose of this study is to elucidate mechanisms whereby oxidative stress induced by acute reflux esophagitis: 1) activates p38 to regulate proteins that control the G1/S cell cycle checkpoint, and 2) activates HIFs (hypoxia inducible factors) to cause autocrine VEGF (vascular endothelial growth factor) signaling that triggers the EMT (epithelial-mesenchymal-transition) program in Barrett's esophagus.

Detailed description: Gastroesophageal reflux disease (GERD) and its complication, Barrett's esophagus (BE), are risk factors for esophageal adenocarcinoma. In BE, GERD causes inflammation with oxidative DNA damage and genomic instability that contributes to carcinogenesis. In BE, one response to oxidative stress is p38 pathway activation, which might protect against cancer development by initiating G1 arrest and enabling repair of DNA damage. Inflammation and oxidative stress also might induce epithelial-mesenchymal transition (EMT), the process in which epithelial cells acquire mesenchymal characteristics including the ability to migrate. This study will elucidate mechanisms whereby the oxidative stress of acute reflux esophagitis in BE activates p38 to regulate proteins controlling the G1/S cell cycle checkpoint, and activates HIFs to cause autocrine vascular endothelial growth factor (VEGF) signaling that triggers the EMT program.

Eligibility: Inclusion Criteria:
  -  U.S. Veteran
  -  Barrett's Esophagus
  Exclusion Criteria:
  -  Inability to provide informed consent
  -  Pregnancy or breastfeeding
  -  Esophageal varices
  -  Warfarin use
  -  Coagulopathy that precludes safe biopsy of the esophagus
  -  Comorbidity that precludes safe participation in the study

Relevance to patient case: not relevant