araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy

Summary: This is an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination will be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on cetuximab or panitumumab treatment. The dose escalation part will be guided by a Bayesian Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC patients who have progressed on cetuximab or panitumumab treatment will be enrolled in two expansion groups to further assess the anti-tumor activity and the safety and tolerability of the combination of INC280 and cetuximab. Patients will receive INC280 on a continuous bid dosing regimen and cetuximab every week. A treatment cycle is defined as 28 days with no scheduled break between cycles.


Eligibility: Inclusion Criteria:
  -  Male or female aged ≥ 18 years
  -  Metastatic colorectal cancer or head and neck squamous cell carcinoma
  -  c-MET positive (defined by c-MET IHC intensity score +2 in ≥ 50% of tumor cells and MET gene copy number ≥ 5 by FISH or IHC intensity score +3 in ≥ 50% of tumor cells) and K/NRAS WT status for mCRC patients only
  -  At least one previous line of treatment for the metastatic disease and the last treatment must have included cetuximab or panitumumab. Documentation of clinical benefit and subsequent progression on cetuximab or panitumumab as the most recent line of treatment is required for patients in the expansion part
  -  Measurable disease as per RECIST v1.1
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  -  Prior treatment with c-MET/HGF inhibitors
  -  History of severe reactions to cetuximab and/or panitumumab (except for G3 rash and G3 hypomagnesaemia)
  -  History of acute or chronic pancreatitis
  -  Active bleeding within 4 weeks prior to screening visit
  -  Symptomatic brain metastases
  -  Feeding tube dependence
  -  Not adequate hematologic, renal and hepatic function
  Other protocol-defined inclusion/exclusion criteria may apply NVS Definition: List only the main study specific inclusion/exclusion criteria that patients will understand.
  Note: DO NOT cut/paste directly from the protocol.
  Do not include age and gender as part of this field. Age and gender are indicated in the 2 fields below.
  Always include statement "Other protocol-defined inclusion/exclusion criteria may apply" at the end of this section.
  Examples:
  Inclusion criteria:
  Patients within 7- 42 days of an acute myocardial infarction associated with left ventricular systolic dysfunction Qualifying Echocardiogram at Visit 1
  Exclusion criteria:
  Presence of clinically overt heart failure Percutaneous coronary intervention (PCI) less than 24 hours before randomization previous treatment with aliskiren
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: definitely relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations

Summary: The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions.
  The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.


Eligibility: Inclusion Criteria:
  -  Male or female aged ≥ 18 years
  -  Histological or cytological confirmed metastatic colorectal cancer
  -  Written documentation of KRAS wild-type status and BRAFV600-mutation with RNF43 mutation and/or RSPO fusion
  -  Progression of disease after at least one prior standard of care regimen or intolerant to irinotecan based regimens
  -  Availability of a representative tumor specimen (primary or metastatic, archival or newly obtained)
  -  Measurable disease as per RECIST v1.1
  -  Eastern cooperative oncology group (ECOG) performance status ≤ 2
  Exclusion Criteria:
  -  Phase II only: Prior treatment with RAF inhibitors, Wnt pathway inhibitors, cetuximab, panitumumab, and/or other EGFR inhibitors
  -  Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed to enroll
  -  Current treatment with medications or consuming foods that are strong inhibitors or inducers of CYP3A4/5 or herbal medications and that cannot be discontinued at least one week prior to the start of treatment.
  -  Symptomatic or untreated leptomeningeal disease
  -  Acute or chronic pancreatitis
  -  Clinically significant cardiac disease
  -  Patients with any of the following laboratory values at Screening/baseline
  -  Absolute neutrophil count (ANC) <1,500/mm3
  -  Platelets < 100,000/mm3
  -  Hemoglobin < 9.0 g/dL
  -  Serum creatinine >1.5 x ULN or calculated or directly measured CrCl < 50% lower limit of normal
  -  Serum total bilirubin >1.5 x ULN
  -  AST/SGOT and/or ALT/SGPT > 2.5 x ULN, (> 5 x ULN if liver metastases present)
  -  Patients with impaired hepatic function as defined by Childs-Pugh class B or C
  -  Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral WNT974/LGX818
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Does Icodextrin Reduce the Risk of Small Bowel Obstruction?

Summary: The study aims at investigating if icodextrin 4% instilled in abdominal cavity during surgery can reduce the risk of surgery and hospitalisation for small bowel obstruction in patients with colorectal cancer. Follow-up data is collected from the Swedish national colorectal cancer registry.Patients are followed for 5 years postoperatively.The study is a randomized Swedish multicenter study and planned to include 1,800 patients. A safety control is planned after 300 included patients.

Detailed description: Icodextrin 7.5% is used in peritoneal dialysis. In animal models and in gynecological surgery a 4% solution of Icodextrin has been tested as a possible agent of reducing adhesions by acting as a barrier between peritoneal surfaces. Some data support a reduction af adhesions (van den Tool et al., Brown et al.). However, is not known whether icodextrin reduces the need for surgery or hospitalisation for small bowel obstruction.This study aims to study these parameters as well as complications and survival.
  Patients with colorectal cancer and scheduled for surgery with curative intent will be (after patients acceptance) randomized to have icodextrin 4% instilled in the abdominal cavity or not. Patients allocated to icodextrin arm will have 100 ml of icodextrin 4% instilled every 30 minutes during surgery and at end of operation further 1000 ml instilled in the abdominal cavity. Postoperative care is performed according to each hospital praxis.
  Follow-up data will be collected from the Swedish National Colorectal cancer registry. Data 30 days postoperatively will be analysed for early small bowel obstruction and other early complications. The study ends 5 years postoperatively with analysis of surgery and hospitalization for small bowel obstruction as well as survival and longterm complications.
  A safety analysis is planned after the first 300 randomized patients with respect to early (30 days) complications. These data will analysed blindly by external reviewers.
  Randomization (1:1) will be performed at the Regional Cancer Centrum in the Uppsala-Örebro region. The study aims to randomise 1800 patients.

Eligibility: Inclusion Criteria:
  -  Colorectal cancer
  -  Curative surgery planned
  -  Informed consent
  -  Age 18-85
  Exclusion Criteria:
  -  Local surgery planned
  -  Generalized disease
  -  Other malignancy
  -  Not informed consent

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Clinical Trial of Quantitative Detection Kit for Hsp90α in Colorectal Cancer

Summary: Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients.

Detailed description: Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.

Eligibility: Inclusion Criteria:
  -  colorectal cancer patients, healthy volunteers, benign colorectal diseases patients
  Exclusion Criteria:
  -  Patients who previously accepted radiotherapy

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

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

Summary: The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Detailed description: Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. But it has not yet been fully explored in solid tumors. The carcino-embryonic antigen(CEA) is widely expressed in cancers like gastric cancer, lung cancer, pancreatic cancer, breast cancer and colorectal cancer. To confirm if CAR T cells still function in solid tumors, we have developed anti-CEA CAR-modified T cells. Preclinical studies have demonstrated effective killing of CEA target cells. In this study, the CEA CARs, will be evaluated in CEA positive gastric cancer, lung cancer, pancreatic cancer, breast cancer and colorectal cancer patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Eligibility: Inclusion Criteria:
  1. Relapsed or refractory CEA positive lung cancer, pancreatic cancer, gastric cancer, breast cancer and colorectal cancer.
  2. KPS>60.
  3. Life expectancy>3 months.
  4. Gender unlimited, age from 18 years to 80 years.
  5. Disease progresses but reserves reaction to recent treatments.
  6. Patients who have failed at least one line of a standard treatment.
  7. No serious mental disorder.
  8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
  9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
  10. No other tumors.
  11. Patients volunteer to participate in the research.
  Exclusion Criteria:
  1. KPS<50.
  2. Patients are allergic to cytokines.
  3. MODS.
  4. Uncontrolled active infection.
  5. Acute or chronic GVHD.
  6. Treated with T cell inhibitor.
  7. Pregnancy and nursing females.
  8. HIV affected.
  9. Other situations we think improper for the research.

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: RCT on Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Care

Summary: This study evaluates the effects of enhanced geriatric input on elderly patients undergoing colorectal cancer surgery. Half of the participants will received additional pre, peri and post-operative care from the geriatric team, while the other half will receive standard surgical care.

Detailed description: Additional geriatric care involves appropriate assessments and interventions by a multidisciplinary team involving geriatricians, physiotherapist, occupational therapist, surgical team, dietician and social worker. It is divided into three stages of care: 1) preoperative assessment, 2) perioperative care and 3) discharge or rehabilitation. In preoperative assessment, a comprehensive geriatric assessment will be carried out which encompasses patients medical and social backgrounds, cognitive status, nutritional assessment and risk factors identification. Perioperative care includes a joint care by surgical and geriatric teams aiming to prevent and treat any postoperative complications. Discharge and rehabilitation aim to identifies and facilities any potential discharge problem or accelerates patients for rehabilitation to the appropriate locations.
  Standard surgical care will be given to patients who are undergoing colorectal cancer surgery but without the additional input mentioned above.

Eligibility: Inclusion Criteria:
  1. Consecutive colorectal cancer patients (aged 70 and over) undergoing elective colorectal cancer surgery at the Prince of Wales Hospital, Shatin, Hong Kong
  2. American Society of Anaesthesiologists fitness score of I, II or III
  Exclusion Criteria:
  1. Colorectal cancer patients aged 69 or under undergoing colorectal surgery
  2. Patients undergoing emergency colorectal cancer resection
  3. Patients with benign pathology
  4. Patients with evidence of locally advanced or metastatic spread of their primary disease
  5. Patient who are unable to give informed consent

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus. mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer.

Summary: The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus. mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Detailed description: The drug being tested in this study is called Panitumumab. This exploratory study will investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus. mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer..
  Tumor tissue samples obtained from the participants who enrolled in the safety/efficacy study of Panitumumab + mFOLFOX versus bevacizumab + + mFOLFOX (PARADIGM Study) and provided consent for this additional study will be used. Mutations, amplification and rearrangement of predefined tumor-associated genes will be investigated using DNA collected from tumor samples used for assessing RAS mutations and plasma free DNA collected before administration of cycle 1 and at the discontinuation of the protocol treatment in the main study.

Eligibility: Inclusion Criteria:
  (1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study
  Exclusion Criteria:
  (1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study

Relevance to patient case: definitely relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer

Summary: This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful the combination of two drugs, panitumumab and trametinib, are in patients with advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).
  Panitumumab is a drug that is approved by Health Canada for the treatment of advanced colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the protein, epidermal growth factor receptor (EGFR) from working.
  Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working.
  Previous studies have shown that the combination of panitumumab and trametinib may be more useful in KRAS, NRAS, or BRAF wild type colorectal cancer.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  KRAS/NRAS/BRAF wild type colorectal cancer, not responsive to standard therapies, no approved or curative therapy, refuse standard therapy
  -  Prior 5-FU, oxaliplatin and irinotecan
  -  ECOG Performance Status of 0 or 1
  -  Able to swallow/retain oral drugs
  -  Able and agree to have provide tumor tissue/have biopsies
  -  Agree to use contraception
  -  Not pregnant
  -  Adequate organ system function
  Exclusion Criteria:
  -  Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies <28 days or 5 half lives
  -  Prior EGFR, MEK, or RAF inhibitor or regorafenib
  -  Current use of prohibited medications
  -  Unresolved side effects
  -  GI disease or other condition affecting GI absorption
  -  Mucosal or internal bleeding
  -  Any major surgery <four weeks
  -  HIV, HBV, or HCV positive
  -  Active infection
  -  Leptomeningeal disease
  -  Brain metastases
  -  Unacceptable QTcF interval
  -  Significant uncontrolled arrhythmias
  -  Acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting < 6 mos.
  -  Class II, III, or IV heart failure
  -  Other clinically significant ECGs
  -  Intra - cardiac defibrillators
  -  Cardiac metastases
  -  Condition that may interfere with patient safety
  -  Hypersensitivity to study drugs
  -  Severe or uncontrolled systemic diseases
  -  Pregnant or lactating
  -  Retinal vein occlusion
  -  Interstitial lung disease or pneumonitis
  -  Active liver or biliary disease

Relevance to patient case: definitely relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)

Summary: National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed colorectal cancer
  2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
  3. Non resectable metastatic disease in a curative intent
  4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment earlier than 6 months ago from inclusion date
  5. Patient presenting with at least one measurable tumour target (greater than 20 mm) according to RECIST criteria, which has never been irradiated
  6. Patient with a greater than 3 month life expectancy
  7. Performance Status less or equal to 2
  8. Male or female 18 years or older
  9. Acceptable blood test
  10. Patient who has signed a written informed consent form
  Exclusion Criteria:
  1. Known and/or symptomatic brain metastases
  2. Known allergy to one of treatment components
  3. Neurological or psychiatric condition which could interfere with good treatment compliance
  4. Patient currently in treatment with any other anti-tumour therapy: chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
  5. Other serious conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrolment/randomisation
  7. Concomitant severe infection.
  8. History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
  9. Patient already included in another clinical trial with an investigational molecule
  10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
  11. Pregnant female, likely to be or currently breast feeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
  12. Those deprived of their freedom or under guardianship
  13. Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons

Relevance to patient case: definitely relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Reducing Sedentary Behaviors Among Colorectal Cancer Survivors

Summary: Interview colorectal cancer survivors and use this input to create a brochure intended to guide reduction of sedentary behaviors in this population. Have colorectal cancer survivors review and comment on a draft of the brochure. A third group of colorectal cancer survivors will wear an Actigraph activity monitor for one week, then receive feedback on their activity level with the brochure. After one month this group will be surveyed by telephone regarding their use of the brochure, and their physical activity level.


Eligibility: Inclusion Criteria:
  -  Adult
  -  Early (stage 1 or 2) colorectal cancer
  -  6 months or greater post treatment
  -  Does not follow guidelines for physical activity
  -  Average at least 6 hours a day of sedentary behaviors
  Exclusion Criteria:

Relevance to patient case: not relevant