araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

Summary: A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant chemotherapy with postoperative chemotherapy in patients with resectable locally advanced colon cancer

Detailed description: For resectable locally advanced colon cancer, the preferred treatment is colectomy with en bloc removal of the regional lymph nodes followed by chemotherapy of about 6 months. However, surgery may postpone the administration of chemotherapy due to postoperative complications such as anastomosis leakage, abdominal infection, thus leads to a poor survival. Some scholars suggested that for patients with locally advanced colon cancer, chemotherapy given before surgery might shrink or downstage tumor, facilitate surgery and promote a better oncological outcome. Whether adjuvant chemotherapy benefits these patients with better outcome still remains controversial.
  In this study, eligible patients will be randomly allocated to receive either adjuvant chemotherapy or not. For patients receiving adjuvant chemotherapy, surgery will be performed 3-4 weeks later. Preoperative and postoperative chemotherapy will be given for a total of about 6 months. For patients receiving no preoperative chemotherapy, chemotherapy will be given for about 6 months postoperatively. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.

Eligibility: Inclusion Criteria:
  -  Patients suitable for curative surgery between 18 to 80 years old;
  -  American Society of Anesthesiologists(ASA) grade I-III;
  -  Pathological diagnosis of adenocarcinoma;
  -  Tumor located between the cecum and sigmoid colon;
  -  Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
  -  Informed consent;
  -  No preoperative chemoradiotherapy;
  -  No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
  Exclusion Criteria:
  -  Pregnant patient;
  -  History of psychiatric disease;
  -  Use of systemic steroids;
  -  Simultaneous multiple primary colorectal cancer;
  -  Preoperative imaging examination results show:
  1. distant metastasis;
  2. unable to perform R0 resection;
  -  Postoperative pathology of T1-T2 N0;
  -  History of any other malignant tumor in recent 5 years;
  -  Patients need emergency operation: mechanic ileus, perforation.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma

Summary: The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.

Detailed description: The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.
  In addition, gene spectrum detection and Mini-PDX are applied for validation of pharmacodynamic.
  Results of clinical trials and pharmacodynamic test will be analyzed to provide evidence for the precise treatment for LCNEC.

Eligibility: Inclusion Criteria:
  -  Stage IIIB or IV pulmonary large-cell neuroendocrine carcinoma confirmed by histology or cytology
  -  Estimated life expectancy over 3 months
  -  Performance status 0,1,2
  -  Signed informed consent
  -  Adequate organ functions: absolute neutrophil count (ANC) over 1,500 cells/mm3 (1.5 x 109/L); platelet count over100,000/mm3 (100 x 109/L); serum creatinine < 2.5 mg/dL (221 mmol/L); serum AST or ALT <5.0 x upper limit of normal (ULN); serum total bilirubin <2.0 mg/dL (34 mmol/L)
  Exclusion Criteria:
  -  History of chemotherapy or molecular targeted therapy
  -  Thoracic radical radiotherapy within 28 days of the initiation of study drug therapy except for palliative radiotherapy
  -  Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy
  -  Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or = to 1 year
  -  Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  -  Pregnant or lactating
  -  Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Phase I Study of TQ-B3395 on Tolerance and Pharmacokinetics

Summary: To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility: Inclusion Criteria:
  -  Histological documentation of Advanced solid tumors,lack of the standard treatment or treatment failure.In expanding stage,enroll the Non-small Cell Lung Cancer with EGFR+(except exon 20)
  -  18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
  -  Main organs function is normal
  -  Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  -  Patients should participate in the study voluntarily and sign informed consent
  Exclusion Criteria:
  -  14 Days or more from the last cytotoxic therapy
  -  Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
  -  Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg，diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥470ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification)
  -  Patients with non-healing wounds or fractures
  -  Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  -  History of immunodeficiency
  -  Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)

Summary: This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer

Detailed description: Peritoneum is one of the common sites of metastasis in advanced stage colorectal cancer patients, resulting in a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is effective to colorectal peritoneal metastasis and may play a significant role in reducing the risk of metachronous peritoneal metastasis among patients with locally advanced colorectal cancer. Oxaliplatin is routinely used for HIPEC in the Europe and Raltitrexed may be another ideal drug for HIPEC. The present phase II multicenter, randomized controlled trial is designed to evaluate the efficacy and safety of adjuvant HIPEC with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer.

Eligibility: Inclusion Criteria:
  -  Joined the study voluntarily and signed informed consent form
  -  Eastern Cooperative Oncology Group performance status of 0 to 1
  -  Life expectancy of more than 5 years
  -  Colorectal adenocarcinoma / mucinous adenocarcinoma / signet ring cell cancer confirmed by histopathology
  -  Stage T4NanyM0 cancer; or stage T3NanyM0 mucinous adenocarcinoma / signet ring cell cancer / adenocarcinoma with partly mucinous adenocarcinoma or signet ring cell cancer
  -  R0 resection of colorectal cancer
  -  Neutrophils (ANC) ≥ 1.5×10^9/L, Platelet count (Pt) ≥ 100× 10^9/L, Hemoglobin (Hb) ≥ 80 g/L, Hepatic function: ALT and AST ≤ 2.5 times upper limit of normal (ULN) and TBIL ≤ 1.5 times ULN, Renal function: creatinine ≤ 1.5 times ULN
  -  Use of an effective contraceptive for adults to prevent pregnancy
  Exclusion Criteria:
  -  Rectal cancer below peritoneal reflection (≤ 8cm above the anal verge)
  -  Other malignant tumors within the past 5 years, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived from radical treatment
  -  Severe adhesion of peritoneal cavity impossible to separate
  -  Abdominal infection
  -  Allergic to raltitrexed, 5-FU, and oxaliplatin; Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
  -  Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  -  Drug addiction, Alcoholism or AIDS
  -  Impossible to tolerate the operation due to severe cardiac, lung, and vascular diseases
  -  Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Phase I Study of TQ-B3234 on Tolerance and Pharmacokinetics

Summary: To study the pharmacokinetic characteristics of TQ-B3234 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility: Inclusion Criteria:
  -  Histological documentation of Advanced solid tumors,such as Malignant Melanoma,Colorectal Cancer,Pancreatic Carcinoma,Thyroid Carcinoma
  -  Lack of the standard treatment or treatment failure
  -  18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
  -  Main organs function is normal
  -  Stop other previous chemotherapy drugs more than 4 weeks
  -  Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  -  Patients should participate in the study voluntarily and sign informed consent
  Exclusion Criteria:
  -  Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
  -  Blood pressure unable to be controlled(systolic pressure>140 mmHg，diastolic pressure>90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥440ms)
  -  Patients with non-healing wounds or fractures
  -  Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  -  History of immunodeficiency
  -  Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement

Summary: The purpose of this study is to evaluate the efficacy and safety of INCB054828 in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.


Eligibility: Inclusion Criteria:
  -  Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
  -  Subjects must be relapsed/refractory. Prior stem cell transplantation is allowed.
  -  Life expectancy ≥ 12 weeks.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  Exclusion Criteria:
  -  Prior receipt of a selective FGFR inhibitor.
  -  History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
  -  Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
  -  Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.

Relevance to patient case: possibly relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics

Summary: To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility: Inclusion Criteria:
  -  Histological documentation of Advanced solid tumors
  -  Lack of the standard treatment or treatment failure
  -  18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
  -  Main organs function is normal
  -  Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  -  Patients should participate in the study voluntarily and sign informed consent
  Exclusion Criteria:
  -  Patients with treatment failure by ALK/ROS1 inhibitor
  -  Patients with anti-teratment,radiotherapy or surgery within 4 weeks
  -  Patients participated in other anticancer drug clinical trials within 4 weeks or ALK/ROS1 inhibitor within 1 week
  -  Blood pressure unable to be controlled(systolic pressure>140 mmHg，diastolic pressure>90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms)
  -  Patients with non-healing wounds or fractures
  -  Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  -  History of immunodeficiency
  -  Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Hysterectomy and OPPortunistic SAlpingectomy

Summary: HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy for a benign reason
  -  has no increased risk of complications
  -  has no negative side effects on ovarian function and subsequent cardiovascular disease or incidence of fractures
  -  implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be conducted within national registers.


Eligibility: Inclusion Criteria:
  -  Planned hysterectomy for a benign reason
  -  Age < 55 years at randomization
  -  Willing to be randomized
  -  Vaginal route may be included if the surgeon is confident with performing vaginal salpingectomy.
  Exclusion Criteria:
  -  Previous bilateral oophorectomy and/or salpingectomy
  -  Planned oophorectomy and/or salpingectomy (for reasons such as already diagnosed adnexal tumor, known carrier of the breast cancer susceptibility gene (BRCA) 1/2 mutation or Lynch syndrome (hereditary nonpolyposis colorectal cancer))
  -  Non-understanding of the oral or written study information

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V)

Summary: This is a Phase II randomized, double-blind, placebo-controlled trial of neoadjuvant artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent.

Detailed description: Colorectal cancer (CRC) is the third most common cancer worldwide and represents a significant health care burden with an incidence of one million new cases per year. In Vietnam, Colorectal cancer is the third most common cause of cancer deaths in men and fourth in women. Artesunate is a safe and effective antimalarial with evidence of anticancer properties across a range of cancer cell lines. Results from a pilot feasibility study in colorectal cancer patients in the UK showed that artesunate was safe and well tolerated. These findings provided the basis for a Phase II clinical trial investigating the effects of neoadjuvant artesunate on progression free survival and overall survival in Stage II/III Colorectal Cancer in Vietnamese Patients.
  Artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent.

Eligibility: Inclusion Criteria:
  -  Aged 18 or over
  -  Histologically proven single primary site colorectal adenocarcinoma
  -  Stage II/III colorectal cancer planned for surgical resection and no clinical indication for neoadjuvant preoperative chemotherapy/chemoradiation therapy
  -  WHO performance status 0,1 or 2
  -  Adequate full blood count: White Cell Count (WCC) >3.0 x 109 /l; Platelets >100 x 109/l; Haemoglobin (Hb) >8g/dL
  -  Adequate renal function : Glomerular Filtration Rate >30ml/min by Cockcroft-Gault formula
  -  Adequate hepatobiliary function : Bilirubin < 3 x Upper limit normal
  -  Female participants of child bearing potential must have a negative pregnancy test < 72 hours prior to initiating study intervention and agree to avoid pregnancy using contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention
  -  Male participants with a partner of childbearing potential must agree to use contraceptive precautions during and for up to 6 weeks after the last dose of the study treatment intervention
  -  Patient able and willing to provide written, informed consent for the study
  Exclusion Criteria:
  -  Contraindication to the use of artesunate due to hypersensitivity
  -  Pregnancy or lactation
  -  History of immunosuppression
  -  History of hearing or balance problems
  -  Weight < 42 kg or > 110 kg
  -  Other planned intervention, apart from Vietnamese standard of care
  -  Any other malignant disease diagnosis within the preceding 2 years with the exception of non-melanomatous skin cancer and carcinoma in situ
  -  Lactose intolerance

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics

Summary: To study the pharmacokinetic characteristics of TQ-B3139 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility: Inclusion Criteria:
  -  Histological documentation of Advanced solid tumors
  -  Lack of the standard treatment or treatment failure
  -  18-65years,ECOG PS:0-1,Life expectancy of more than 3 months
  -  Patients with anti-treatment or surgery within 4 weeks
  -  Main organs function is normal
  -  Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  -  Patients should participate in the study voluntarily and sign informed consent
  Exclusion Criteria:
  -  Patients participated in other anticancer drug clinical trials within 4 weeks
  -  Blood pressure unable to be controlled(systolic pressure>140 mmHg，diastolic pressure>90 mmHg).
  Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms)
  -  Patients with non-healing wounds or fractures
  -  Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  -  History of immunodeficiency
  -  Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Relevance to patient case: not relevant