araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel

Summary: This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve participants with early-stage or locally advanced HER2-positive breast cancer. The anticipated treatment duration is approximately 17 months.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (>) 2 centimeters (cm) by standard local assessment technique
  -  Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0)
  -  HER2-positive breast cancer confirmed by a Sponsor-designated central laboratory and defined as 3+ score by immunohistochemistry in > 10 percent (%) of immunoreactive cells or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals equal to or more than [>=] 2.0) by in situ hybridization
  -  Known hormone receptor status (estrogen receptor and/or progesterone receptor)
  -  Eastern Cooperative Oncology Group Performance Status equal to or less than (<=) 1
  -  Baseline left ventricular ejection fracture >= 55% measured by echocardiography (preferred) or multiple gated acquisition scan
  -  Negative serum pregnancy test
  Exclusion Criteria:
  -  Stage IV metastatic breast cancer
  -  Inflammatory breast cancer
  -  Previous anti-cancer therapy or radiotherapy for any malignancy
  -  History of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
  -  Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy
  -  Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered
  -  Serious cardiac illness or medical condition
  -  Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
  -  Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization
  -  Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol
  -  Pregnant or lactating

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Liquid Biopsy in Monitoring the Therapeutic Efficacy of Targeted Therapy in Advanced/Metastatic Gastric Cancer

Summary: To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in histologically confirmed HER2 positive advanced/metastatic gastric cancer.

Detailed description: The study is a single-center, prospective study undertaken in anticipated 124 patients with both histologically HER2 positive and negative advanced/metastatic gastric cancer. Peripheral blood samples of 12.5 mL were collected from the patients for cfDNA and CTCs analysis. The blood samples will be respectively drawn before therapy, at the time that the patients achieve the optimal response and when they suffer progressive disease. The enumeration of CTCs as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Further, for the geneomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. The correlation of the HER2 status on CTCs and the HER2 amplification in cfDNA to the therapeutic response will be evaluated. Moreover, gene variations associated with resistance in HER2-targeted therapy will be also studied based on the genomic data from sequencing of CTC and cfDNA.

Eligibility: Inclusion Criteria:
  -  Having signed informed consent
  -  Age≥ 18 years old
  -  Histologically confirmed HER2 positive gastric adenocarcinoma
  -  Unresectable recurrent or metastatic disease
  -  Measurable disease according to the RECIST criteria
  -  Karnofsky performance status ≥60
  -  Life expectancy of ≥2 month
  -  ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
  -  Serum albumin level ≥3.0g/dL
  -  Serum AKP < 2.5 times ULN
  -  Serum creatinine <ULN, and CCr < 60ml/min
  -  Bilirubin level < 1.5 ULN
  -  WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl
  Exclusion Criteria:
  -  Brain metastasis (known or suspected)
  -  Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry. Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
  -  Allergic constitution or allergic history to protium biologic product or any investigating agents.
  -  Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
  -  Pregnancy or lactation period
  -  Other previous malignancy within 5 year, except non-melanoma skin cancer
  -  Pre-existing neuropathy>grade 1
  -  Legal incapacity

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI Treatment

Summary: This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.


Eligibility: Inclusion Criteria:
  -  Age older than 18 years and under 75 years
  -  Histologically and cytologically proven non-small Cell Lung Cancer
  -  Clinical stages Ⅲ ~ Ⅳ
  -  Not receive any anti-tumor treatment
  -  Eastern cooperative oncology group performance status (ECOG PS) =1~2
  -  Estimated survival time more than 3 months
  -  EGFR-TKI treatment for first-line or second-line
  -  Voluntary to participate in this clinical trial and sign the consent form
  Exclusion Criteria:
  -  Patients have received EGFR-TKI therapy before the study
  -  With other malignancy history in the recent 5 years before the study
  -  Pregnancy or breast feeding phase
  -  Inadequate samples for testing
  -  Follow-up compliance is poor

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Postoperative Enteral Immunonutrition in Gastric Cancer

Summary: Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
  The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
  The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Detailed description: Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%.
  Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.
  The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.
  The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Eligibility: Inclusion Criteria:
  -  gastric cancer confirmed in histopathological examination
  -  elective operation due to gastric cancer
  -  informed consent signed
  -  age > 18 years
  -  normal nutritional status or mild to moderate malnutrition
  Exclusion Criteria:
  -  severe malnutrition which required parenteral nutrition
  -  urgent operation

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System

Summary: This phase I trial is to investigate the safety and the possible side effects of bi-specific antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.

Detailed description: PRIMARY OBJECTIVES:
  I. Perform a phase I clinical trial to clearly define the toxicity profile of IV HER2Bi armed T cells in patients with neoplasms of digestive system.
  SECONDARY OBJECTIVES:
  I. Evaluate phenotype, cytokine profiles and tumor markers, cytotoxicity directed at laboratory Her2 positive cancer cell lines.
  II. Evaluate the clinical symptoms and signs, clinical responses, imaging examination of pretherapy and post-treatment, cytokine profiles and tumor markers in serum before and after treatment, time to progression, and overall survival.
  OUTLINE: This is a safety study of IV infused HER2Bi-armed activated T cells. Patients receive HER2Bi armed T cells IV weekly for 4 weeks. Patients also receive low-dose Interleukin subcutaneously (SC) daily beginning 3 days before the first HER2Bi armed T cells infusion. Treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility: Inclusion Criteria:
  1. Patient with Her2-positive neoplasms of digestive system: IHC 3+
  2. Clinical staging: Phase III or above
  3. Ages: < 65
  4. Expected survival time: > 1 year
  5. Quality of Life: > 60
  6. The functions of important organs( heart, liver, lung, kidney and etc.)are normal
  7. The volunteers with informed consent
  Exclusion criteria:
  1. Patient with Her2-negative neoplasms of digestive system
  2. Hepatic renal dysfunction
  3. Cardiopulmonary insufficiency
  4. Mental disorder
  5. Allergic condition
  6. With other malignant tumor
  7. Lactating women
  8. Patients with infection or received chemotherapy in the past two weeks
  9. Patient with autoimmune disease using immunosuppressive drug
  10. Patient with organ transplantation with long term use of immunosupresive drug

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Serological Screening of Gastric Cancer in Wuxi Region

Summary: The purpose of this study is to determine whether detection of pepsinogen Ⅰand Ⅱ combined with Helicobacter pylori antibody, so-called ABC method , is fit on gastric cancer screening in community of Wuxi City.

Detailed description: Gastric cancer is the third largest cause of cancer related deaths in China with about 350 ,000 gastric cancer-related deaths by gastric cancer in 2012. The studies from Japan and Korea have found gastric cancer screening, especially of the mass population, reduces mortality from gastric cancer, but the data is seldom in China. The ways include radiographic and endoscopic screening, although those methods were shown to reduce gastric cancer mortality, and was recommended as gold standard for population-based screening by Japan and Korea, but many problems have been pointed out: A serious drawback is low uptake of the target population; fear for radiation exposure(0.6 mSv), swallowing unpleasantness due to the use of barium meal, accidental fall during the examination and constipation, causing rare but more serious complications such as intestinal obstruction or diverticulitis after examination may account for the reasons for this low uptake, endoscopic screening is labor-intensive, more costly per examination as complete disinfection of the scope is mandatory, and requires a large number of well-trained experienced endoscopists.
  Serological method, so-called ABC method , has been useful as gastric cancer preliminary screening in some areas, such as China, Japan and Korea. The major reasons are attributed to its simplicity, safety (radiation-free, discomfort free), and cost-efficiency. The ABC method is a blood test to stratify the risk of gastric cancer using the combination of H. pylori antibody and pepsinogen I and II, that was documented by large-scale studies in Japan. But the data was short in China, especially in the community.

Eligibility: Inclusion Criteria:
  Age 40-70 years old, men and women are not limited, and there are one of the following:
  1. Hp infected.
  2. Previously suffering from chronic atrophic gastritis, gastric ulcer, gastric polyps, hypertrophic gastritis, pernicious anemia and other precancerous diseases of the stomach.
  3. First degree relatives of patients with gastric cancer.
  4. Other risk factors for gastric cancer. (high salt, salted diet, smoking, heavy drinking, etc.)
  Exclusion Criteria:
  1. Severe heart, liver, kidney, dysfunction or mental disorders
  2. History of gastric surgery (including surgery, minimally invasive EMR, ESD)
  3. Use of PPI, acid preparation, stomach protecting agent in the first two weeks
  4. The researchers considered inappropriate participants.
  5. Informed consent cannot be attained

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Tumor Markers Study in Gastric Cancer for Cancer Immunotherapy (ONCO-RD 010 CRT)

Summary: Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Despite advances in therapeutic intervention, the mortality from this disease remains high. As a result, most patients are now offered varying combinations of surgery, chemotherapy, and radiation therapy in order to derive benefits from a multidisciplinary approach. Unfortunately, therapies are often toxic or debilitating and therapeutic responses can vary. Thus new therapeutic strategy is required for the treatment of gastric cancer.
  In the early 1980s, the discovery of cytolytic T cells (cytolytic T lymphocytes, CTLs) directed against an antigen presented on tumor cells was published. They can kill many invasive cells by recognizing the tumor specific antigens on the major histocompatibility complex (MHC) molecules. It is now generally agreed that although tumors express tumor antigens, they usually lack immunogenicity because of their inability to activate the immune response. The current view is that tumor cells are antigenic, but not immunogenic. If we can artificially activate the immune system against the tumor, it may be possible to eradicate the tumor. This approach is the basis of cancer immunotherapy.
  Many tumor antigens have been defined in terms of multiple solid tumors: MART-1/Melan-A, gp100, carcinoembryonic antigen (CEA), HER-2, mucins (i.e., MUC-1), prostate-specific antigen (PSA), and prostatic acid phosphatase (PAP) are just a short list. Some immune-based therapies targeting these tumor antigens are in phase III trials assessing whether immunizing against these antigens affects overall survival. In gastric cancer, some tumor antigens such as MAGE-A3, NY-ESO-1, and WT-1 have been reported to be expressed in substantial proportion of cases. They have the potential to be the targeting molecules for immunotherapy in the future. In this study, we aim to explore the expression levels of the four tumor markers (MAGE-A3, NY-ESO-1, WT-1 and PRAME) in gastric cancers of Korean patients and to examine the correlations of the expression levels of the four markers to clinic-patholoical factors.


Eligibility: Inclusion Criteria:
  -  gastric carcinoma
  -  received gastrectomy
  Exclusion Criteria:
  -  neoadjuvant therapy

Relevance to patient case: possibly relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of sirolimus in patient with Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors 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.
  sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of sirolimus in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration( H1047R, E542K, E545K, PTEN LOSS) Refractory solid tumor and/or specific sensitivity to mTOR inhibitors 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.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  Adequate Organ Function Laboratory values
  -  Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=75 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with sirolimus

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer

Summary: Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.


Eligibility: Inclusion Criteria:
  1. Relapsed or refractory HER2 positive cancer.
  2. KPS>60.
  3. Life expectancy>3 months.
  4. Gender unlimited, age from 18 years to 80 years.
  5. Assessable lesions with a minimum size of 10mm by CT scan or MRI.
  6. Acceptable organ function
  Hematology:
  -  Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim.
  -  White blood cell (WBC) (> 2000/mm^3).
  -  Platelet count greater than 50,000/mm^3.
  -  Hemoglobin greater than 9.0 g/dl.
  Chemistry:
  -  Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).
  -  Serum creatinine less or equal to 3 times the upper limit of normal
  -  Total bilirubin less than or equal to 3 times the upper limit of normal.
  7. No other serious diseases(autoimmune disease, immunodeficiency etc.).
  8. Adequate cardiac function(LVEF≥40%).
  9. No other tumors.
  10. Patients volunteer to participate in the research.
  Exclusion Criteria:
  1. Allergic to cytokines.
  2. Uncontrolled active infection.
  3. Acute or chronic GVHD.
  4. MODS.
  5. Treated with T cell inhibitor.
  6. HIV affected.
  7. Other situations improper for the research.

Relevance to patient case: not relevant