araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors

Summary: This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2 Amplification Refractory solid tumors.
  This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.
  To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. RET fusion positive,FGFR amplification, Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. 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 subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. Any previous treatment with sunitinib

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Single-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors

Summary: This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation Refractory solid tumors.
  This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.
  To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. FGFR2 amplification or FGFR2 mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 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 subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. Any previous treatment with Pazopanib.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: RhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer

Summary: This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers.

Detailed description: This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers. Patients were randomly assigned to rhGM-CSF group or placebo group and treated with rhGM-CSF or placebo perioperation and during the adjuvant chemotherapy. The purpose of the study is to evaluate the antitumor immune effect of rhGM-CSF before surgery and adjuvant chemotherapy through DFS of 5 years and to observe the safety during the treatment in order to provide evidence for improvement in treating resectable colon cancer patients.

Eligibility: Inclusion Criteria:
  1. Diagnosed as resectable stage III colon cancer
  2. 18-70 years old
  3. ECOG performance status ≤2
  4. Unexposed to rhGM-CSF in 6 months
  5. Signed an informed consent document
  Exclusion Criteria:
  1. Secondary primary cancer, or concurrent primary malignancies (except for basal cell or squamous cell skin cancer, cervical cancer in situ, and other cancer with disease free for more than 5 years)
  2. Complete intestinal obstruction
  3. Events within 6 months before randomization: myocardial infarction, sever or unstable angina, coronary artery or peripheral arterial bypass surgery, congestive heart failure ( NYHA functional class of III or IV ), stroke and any myocardial dysfunction in a transient ischaemic attack
  4. Abnormal liver and kidney function (Serum creatinine > 1.5 x ULN, total bilirubin > 1.5 x ULN, transaminase > 3 x ULN ), abnormal pulmonary function (FEV1<60% or diffusing capacity of the lung for carbon monoxide < 55% )
  5. Bone marrow dysfunction ( Hb<9.0 g/dL、ANC<1.5 x 109/L、PLT<100 x 109/L )
  6. ITP or immunodeficiency
  7. Uncontrolled infection, including HBV, HCV, HIV infection
  8. Female patients who has been pregnant or planning to, and those during lactation
  9. Known allergic to E.coli agents or rhGM-CSF or any severe allergic history to other drugs
  10. Other cases that the researcher found ineligible

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Pilot Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With HER-2 Positive Metastatic Cancer

Summary: Immune-based therapies (vaccines) are a new focus of clinical investigation. These therapies try to assist a patient's immune system (a system in our bodies that protects us against infection) in killing tumors. One form of such therapy is the dendritic cell combined with HER-2/neu (a type of protein over-expressed in some cancers) vaccine. Dendritic cells are immune cells that can tell your immune system to fight infection. In laboratory testing, these cells may also help the immune system attack tumors such as breast, kidney cancer or skin cancer. The purpose of this research study is to determine if it is both possible and safe to administer" this vaccine to patients with any HER2+ cancer.

Detailed description: We have demonstrated that administration of HER-2/neu pulsed DC1 in patients with DCIS results in strong immunologic responses as well as clinical responses during a brief 4 or 6 week neoadjuvant vaccination. In subsets of patients with cancer HER-2 is over-expressed including subsets of breast, gastric, pancreatic, brain, lung, and colon cancer. This trial is designed for compassionate use of a HER-2/neu pulsed DC1 in patients with metastatic HER-2 positive cancer, who have no longer standard options to eliminate disease.

Eligibility: Inclusion Criteria:
  1. Age ≥ 18 years.
  2. Subjects with active metastatic HER-2 positive cancer, at least 1+ by IHC, that have already received standard therapy who have exhausted other treatment options.
  3. Subjects with HER-2 1+ need to be HLA 2 or HLA A3 positive. There are no HLA restrictions for HER-2 2+ or 3+.
  4. Women of childbearing age with a negative pregnancy test documented prior to enrollment.
  5. Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
  6. Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study.
  7. Subjects who have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
  -
  Exclusion Criteria:
  1. Pregnant or lactating females.
  2. Subjects with positive HIV or hepatitis C at baseline by self report.
  3. Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec
  4. Subjects with major cardiac illness MUGA or ECHO < 50% EF.
  5. Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by PI.
  6. Subjects receiving current therapy that may suppress immune system, such as steroids, chemotherapy at the discretion of the PI.

Relevance to patient case: definitely relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

Summary: The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.

Detailed description: This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
  One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.

Eligibility: Inclusion Criteria:
  -  Subject is male or female, 40-90 years of age, inclusive.
  -  Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
  -  Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
  Exclusion Criteria:
  -  Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
  -  Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Synergistic Anti-tumor Effect of ChangTai Keli for Colon Cancer Patients

Summary: The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients by a randomized, parallel-group, double-blind, multicenter clinical study.

Detailed description: Although many therapies exist and are being developed to relieve symptoms for colon cancer, there are few randomized controlled clinical trials to evaluate comprehensive Traditional Chinese medicine (TCM) interventions in colon cancer. The aim of this study is to evaluate the synergistic anti-tumor effect of ChangTai Keli based on chemotherapy for colon cancer patients. This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the synergistic anti-tumor effect of TCM on colon cancer patients. Following a run-in period, approximately 360 subjects will be randomly assigned to conventional chemotherapy treatment group, ChangTai Keli and conventional chemotherapy treatment group for 26 weeks. After the 26 weeks treatment period, subjects in two treatments arms will follow-up 36 months.

Eligibility: Inclusion Criteria:
  1. collaboration from hospital oncology patients in hospital. Confirmed by pathology or cytology for colon cancer, Ⅱ A - Ⅳ period of patients with colon cancer line (or late postoperative palliative chemotherapy).
  2. age > 18 years of age, and the 75 - year - old patient or less;
  3. fitness score (ECOG PS) 2 minutes or less, expected lifetime > 6 months;
  4. volunteered for the clinical research, and sign the informed consent.
  Exclusion Criteria:
  1. patients with other primary malignant tumors within 1 year;
  2. intentional, severe liver and kidney disease patients with serious obstacle and function;
  3. pregnancy or lactation women, mental disorders to cooperate to complete the healer;
  4. is in other subjects or attended other drugs test interval < 3 months.
  5. do not meet the inclusion criteria;

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: QoLiCOL - Quality of Life in Colon Cancer

Summary: All patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. They will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. Clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal Cancer Registry (SCRCR)

Detailed description: QoLiCOL is an explorative, prospective, longitudinal, non-interventional, international, multicenter study of health-related quality of life, physical symptoms, functional impairments and socioeconomic burden in colon cancer patients. All patients presenting at participating hospitals during the recruitment period with a newly diagnosed rectal cancer, regardless of stage and planned treatment, will be eligible for inclusion. Patients will be followed for 3 years. They will be asked to answer questionnaires at three different time points during follow-up: at diagnosis and after 12 and 36 months. Clinical data, including recurrence, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the national quality registry for rectal cancer in Denmark and Sweden. As these registries differ in some areas between the countries, additional data will be collected through short CRF:s.

Eligibility: Inclusion Criteria:
  -  Colon cancer newly diagnosed.
  -  Planned treatment presented
  Exclusion Criteria:
  -  No Colon cancer diagnosis,
  -  below 18 years of age,
  -  no informed consent or withdrawn informed consent.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

Summary: This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance.

Detailed description: In a clinical context, there is a lack of molecular compounds with demonstrated clinical activity in delaying/reversing resistance to endocrine agents. CDK 4/6 inhibitors may represent a biologically-driven option in this context.
  With the present study investigators aim to complement the ongoing trial on PD0332991 by acquiring information on its clinical activity in post-menopausal patients with ER positive, Her2 negative advanced breast cancer patients already pretreated with a first-line or second line endocrine therapy.

Eligibility: Inclusion Criteria:
  -  Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease
  -  ER positive tumor ≥ 10%
  -  HER2 negative breast cancer by FISH or IHC
  -  Progression of advanced breast cancer on first or second line endocrine therapy for advanced breast cancer
  -  Paraffin-embedded tumor available for centralized assessment of biomarkers
  -  Measurable disease according to RECIST 1.1 (bone only disease is allowed only if measurable).
  -  Postmenopausal status
  -  Eastern Cooperative Oncology Group (ECOG) Performance status 0 -2
  -  Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade >1
  -  Adequate organ function
  Exclusion Criteria:
  -  Unstable brain metastases
  -  Prior treatment with more than one line of CT or more than two lines of HT advanced breast cancer or any CDK inhibitor
  -  Current treatment with therapeutic doses of anticoagulant
  -  Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors / inducers, drugs that are predominantly metabolized by CYP3A with narrow therapeutic indices, drugs with the potential of prolonging QT interval
  -  Diagnosis of any secondary malignancy within the last 3 years
  -  Active inflammatory bowel disease or chronic diarrhea
  -  Known human immunodeficiency virus infection; active hepatitis C, active hepatitis B

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Efficacy of Segmental Examination Twice of the Proximal Colon on Adenoma Detection

Summary: Segmental examination twice of the proximal colon might be helpful to increase adenoma detection rate (ADR).

Detailed description: Colonoscopy is the gold standard screening test for colorectal cancer (CRC). Removal of adenomas can reduce the incidence and mortality of CRC. However, there is evidence that some patients may develop interval cancers—cancers developed within 3-5 years following colonoscopy and polypectomy. The overall rate of interval cancer was 1.1-2.7 per 1000 person-years. Several studies have suggested that patients who develop interval cancers are more likely to have proximal compared than distal cancers.
  One hypothesis is that adenomas may be more likely to be missed in the proximal colon compared with the distal colon. Serrated polyps and some adenomas in the proximal colon may be difficult to detect if they are flat, covered with mucus, or behind folds. A second hypothesis is that neoplastic lesions of the proximal colon may biologically differ from distal lesions and progress to malignancy with a short dwell time.
  Several tandem back to back colonoscopy studies have demonstrated that up to 27% adenomas in the proximal colon are missed during routine screening colonoscopy. Hover, examining the colon twice as that in the back to back studies is difficult to be performed in clinical practice. Thus, we developed a novel colonoscopy technique, segmental examination twice of the proximal colon, that is simple and easy to be performed. The current study aims to examine the efficacy of segmental examination twice of the proximal colon on adenoma detection rate (ADR) during routine screening and surveillance colonoscopy.

Eligibility: Inclusion Criteria:
  -  Asia-Pacific Colorectal Screening score ≥2, such as patients ≥ 50 years, patients with a family history of colorectal cancer in a first-degree relative or male patients with current or past smoking.
  Exclusion Criteria:
  -  Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome.
  -  The cecum could not be intubated.
  -  Inadequate bowel preparation (Boston Bowel Preparation Scale score <2 in any segment of the colon).
  -  Biopsies were not available.
  -  Unable to provide informed consent.

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: ERBB2 amplification

Clinical trial: Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC).

Summary: To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve disease-free survival in patients with right colon cancer, compared with standard D2 radical operation.

Detailed description: Our study design is a two-arm, parallel-group, single-blind randomized clinical trial. The enrolled colon cancer patients would be divided into the intervention group (CME group) and control group (D2 radical operation group).
  The postoperative adjuvant chemotherapy is determined by the pathological results. For patients of stage Ⅲ and patients of stage Ⅱ with unfavorable histologic features, six months of adjuvant chemotherapy of XELOX or fluorouracil-based regimen are recommended.
  The postoperative examination should be performed every four months in the first two years and every six months in the following three years, to exclude local recurrence and distant metastasis.
  Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.

Eligibility: Inclusion Criteria:
  1. Patients suitable for curative surgery 18-75years old
  2. ASA grade I-III
  3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
  4. Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
  5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T2-T4N0 or TanyN+; there is no distant metastasis.
  6. Informed consent
  Exclusion Criteria:
  1. Simultaneous or simultaneous multiple primary colorectal cancer;
  2. Preoperative imaging examination results show: (1) colon cancer of stage T1N0; (2) enlargement of lymph node at the root of mesocolon, in which case the D3 radical operation must be performed;
  3. Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
  4. History of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin;
  5. Patients need emergency operation;
  6. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
  7. Informed consent refusal

Relevance to patient case: not relevant