There is also the possibility of accepting book reviews of recent publications related to General and Digestive Surgery. The Impact Factor measures the average number of citations received in a particular year by papers published in the journal during the two receding years. CiteScore measures average citations received per document published. Read more.

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Print Download. Examples: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field. Print Download Summary. Review by the Competent Authority or Ethics Committee in the country concerned.

As of 1. EU Clinical Trials Register. Search tools. Select Date Range: to. Select Rare Disease:. IMP with orphan designation in the indication. Orphan Designation Number:. Results Status: Trials with results Trials without results.

Clear advanced search filters. Date on which this record was first entered in the EudraCT database:. Title of the trial for lay people, in easily understood, i. The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy. Sponsor will conduct Future Biomedical Research on DNA blood, tumor material specimens collected during this clinical trial.

Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol as part of the main trial and will only be conducted on specimens from appropriately consented subjects. Lesions situated in a previously treated area by either radiotherapy, photodynamic therapy, or arterial embolization are considered measurable if progression has been demonstrated in such lesions and they meet criteria for measurable disease.

Participants with past or ongoing HCV infection are eligible for the study. Treated participants must have completed their treatment at least 1 month prior to starting study intervention. Untreated or incompletely treated HCV participants may initiate anti-viral therapy for HCV if liver function remains stable for at least 3 months on study intervention.

Antiviral therapy after completion of study intervention should follow local guidelines. Is male or female, from at least 18 years of age inclusive, at the time of signing the informed consent. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. The participant or legally acceptable representative, if applicable provides written informed consent for the study.

Have a performance status of 0 or 1 on the ECOG Performance Scale within 3 days prior to the first dose of study intervention. Provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated ie, obtained for histological confirmation for biomarker analysis. The tumor tissue must be received by the central vendor and be deemed adequate for biomarker analysis evaluation prior to participant randomization.

Formalin fixed, paraffin-embedded FFPE tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Read in the protocol. El participante o su representante legal cuando proceda otorga su consentimiento informado por escrito para el estudio 9. Se prefieren los bloques de tejido fijados en formol e incluidos en parafina FFIP a los cortes para microscopio. Se prefiere el uso de biopsias recientes al tejido de archivo.

Leer en el protocolo. Has had previous systemic therapy for advanced metastatic or unresectable locallyadvanced biliary tract cancer intra-or extra hepatic cholangiocarcinoma or gallbladder cancer , with the exception of adjuvant therapy which is allowed.

Has ampullary cancer. Has an active autoimmune disease that has required systemic treatment in the past 2 years ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs.

Replacement therapy eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc. A WOCBP who has a positive urine pregnancy test within 24 hours prior to administration of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Has received prior anti-cancer therapy for advanced unresectable biliary tract cancer intra-or extra hepatic cholangiocarcinoma or gallbladder cancer , including investigational agents within 4 weeks prior to randomization.

Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and have not had radiation pneumonitis. Has received a live vaccine within 30 days prior to the first dose of study intervention. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in dosing exceeding 10 mg daily of prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis.

Has a known history of human immunodeficiency virus HIV infection. Has known active tuberculosis. Has a history or current evidence of any condition, eg, hearing impairment, etc.

Presencia de tuberculosis activa Bacillus tuberculosis. Antecedentes o datos presentes de cualquier proceso por ejemplo, hipoacusia, etc. Overall Survival OS. Supervivencia global SG. Up to 48 months 2. Up to 48 months. Up to 48 months 3. Up to 48 months 4. Health Utility Scores; anti-MK antibody levels. The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial.

Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition.

Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study.


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