[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100584646","phase-1-sotorasib-combined-with-first-line-chemotherapy-for-advanced-pancreatic-adenocarcinoma-100584646",false,"NCT06892054","Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma","Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma With KRAS p.G12C Mutation","PANSOTO","Inclusion Criteria:\n\n1\\) Willing and able to provide informed consent. 2) Men or women aged ≥ 18 years old. 3) Using effective contraceptive measures or sexual abstinence during the treatment, up to 7 days after the last dose of sotorasib, for at least 6 months after the last dose of gem\u002Fnab-P and for 15 months after the last dose of mFOLFIRINOX for woman of childbearing age and 12 months after stopping mFOLFIRINOX for men:\n\n* Female of childbearing potential using a highly effective method of contraception (i.e., a method with less than 1% failure rate \\[e.g., sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner\\])\n* Male agreeing to use condoms or having a partner who is using a highly efficient method of contraception as described above 4) Pathologically confirmed treatment-naïve of locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation assessed by means of a IVDR compliant test) 5) Measurable disease per RECIST 1.1 criteria. 6) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7) Life expectancy \\> 3 months, in the opinion of the investigator. 8) Adequate hematologic, renal and hepatic organ function, defined as the following within 10 days prior study inclusion:\n* Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n* Hemoglobin ≥ 9.0 g\u002FdL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n* Platelet count ≥ 100 x 109\u002FL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n* Aspartate aminotransferase (AST) and ALT ≤ 2.5 times the upper limit of normal (ULN) or ≤5 times if liver metastasis\n* Serum bilirubin ≤ 1.5 x ULN\n* International normalized ratio (INR) ≤ 1.5 x ULN. Prothrombin time (PT) ≤ 1.5 x ULN may be used instead of INR for sites whose laboratory do not report INR\n* Creatinine clearance ≥ 30 mL\u002Fmin (estimated by Cockcroft-Gault equation) 9) Ability to take oral medications and willing to record daily adherence to investigational product.\n\nExclusion Criteria:\n\n1. Patients with resectable or borderline resectable pancreatic cancer.\n2. Known history or positive viral test for human immunodeficiency virus (HIV).\n3. Peripheral sensory neuropathy. 4 )Proven complete dihydropyrimidine dehydrogenase (DPD) deficiency for patients that will be treated with mFOLFIRINOX.\n\n5\\) Poor nutritional status (albumin \\\u003C3 g\u002FL or weight loss \\>10% during the last 4 weeks).\n\n6\\) Patients with known active hepatitis (i.e., Hepatitis B or C)\n\n* Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA 7) Female: currently pregnant or breast-feeding or who plan to breastfeed while on study though 7 additional days after the last dose of sotorasib and for at least 6 months afterwards after the last dose of gem\u002Fnab-P or 15 months after the last dose of mFOLFIRINOX.\n\n  8\\) Myocardial infarction within 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association \\> class II), unstable angina, or cardiac arrhythmia requiring medication 9) Prior anti-tumor treatment for metastatic or locally advanced pancreatic adenocarcinoma\\*. Prior chemotherapy or radiotherapy in the adjuvant or neoadjuvant setting is acceptable if received \\> 6 months prior to study enrolment\n\n  \\*If initiation of treatment is deemed urgent by the investigator, patients can receive 1st month of Standard of Care (SoC) gem\u002Fnab-P (1 cycle) or FOLFIRINOX (2 cycles) during screening. This first month of gem\u002Fnab-P or FOLFIRINOX is not a requirement of the study and is not part of this clinical study 10) Active infection requiring antibiotics within 1 weeks of study enrollment. 11) Other malignancy unless curatively treated with no evidence of disease for ≥2 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, and\u002For ductal carcinoma in situ.\n\n  12\\) Significant gastrointestinal disorder that results in significant malabsorption, requirement for IV alimentation, or inability to take oral medication.\n\n  13\\) History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.\n\n  14\\) Presence of any condition that, in the opinion of the investigator, renders the patient at high risk from treatment complications or might affect the interpretation of the results of the study.\n\n  15\\) Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to patient safety, in the opinion of the investigator.\n\n  16\\) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Patients with PleurX catheters or intraperitoneal drainage catheters in place may be considered for the study with Medical Monitor approval.\n\n  17\\) Major surgery within 4 weeks of study Day 1 18) Prior\u002Fconcomitant therapy:\n* Previous treatment with a KRASG12C inhibitor\n* Use of warfarin. Other anticoagulation may be allowed\n* Use of known cytochrome P450 (CYP) 3A4 sensitive substrates and P-glycoprotein (P-gp) substrates (with a narrow therapeutic window), within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to study Day 1 (see examples of sensitive substrates and P-glycoprotein substrates in Appendix A) except for those investigational treatments administered as part of the study scheme that will be subject to specific PK analysis.\n* Use of strong inducers of CYP3A4 (including herbal supplements such as St John's wort) within 14 days or 5 half-lives (whichever is longer) prior to study Day 1 (see examples of strong inducers of CYP3A4 in Appendix A)\n* Live attenuated vaccines (against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus and influenza), within 30 days prior of the first dose of study treatment.\n* Brivudine-based treatments within 4 weeks before treatment with 5-fluorouracil. 19) Patient has known sensitivity to any of the products or components to be administered during the study.\n\n  20\\) History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The main objective of this trial is to evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.",[27],"Pancreatic Adenocarcinoma",[29,30,31,32],"Pancreatic","sotorasib","TTD-24-01","KRASG12C","RECRUITING","2026-04-24",{"date":36,"type":37},"2026-04-30","ACTUAL",{"date":39,"type":37},"2025-08-08",{"date":41,"type":21},"2030-08-08",{"name":43,"class":44},"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)","OTHER",26,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100570743","spanish-registry-of-digestive-tumours-retud-100570743","NCT06711211","Spanish Registry of Digestive Tumours RETUD","A Descriptive, Multicentre, Observational Epidemiological Study on Digestive Tumours","RETUD","Inclusion Criteria:\n\n* Male and female patients ≥18 years old diagnosed with oesophageal cancer, gastric cancer, pancreatic cancer, hepatocarcinoma, gallbladder and bile duct cancer, cancer of the small intestine, appendix and gastrointestinal stroma, colorectal cancer, anal canal cancer or digestive hereditary cancer.\n* Written informed consent available.\n\nExclusion Criteria:\n\n* Patient for whom, for whatever reason, it is not possible to know or obtain the information necessary to complete the data collection base.",{"count":55,"type":21},20000,"10 Years","OBSERVATIONAL","The aim of this observational study is to assess the current state of digestive tumours in Spain. By doing so, it seeks to enhance the quality of care, optimize the diagnosis and treatment of digestive tumours, and identify opportunities for improvement that can benefit patients.\n\nThe study will investigate the epidemiological, biological, and clinical characteristics of digestive tumors diagnosed in patients aged 18 and older across healthcare centres in Spain. It also aims to generate knowledge and scientific evidence for events and situations that may impact on patients with digestive tumours (e.g. COVID-19 coronavirus pandemic).\n\nFurthermore, subject to the patient's consent, biological samples may be collected for use in translational research projects and for the identification of molecular markers that may be useful in healthcare decision-making.",[60,61,62,63,64,65],"Digestive Cancers","Bile Duct Cancer","Hepatocellular Cancer (HCC)","Colorectal Cancer (CRC)","Pancreatic Cancer","Rectal Cancer",[67,68,69,70,71,72,73,74],"digestive","cancer","tumours","cholangiocarcinoma","hepatocellular","colorectal","pancreas","rectal","2024-11-27",{"date":77,"type":37},"2024-12-02",{"date":79,"type":37},"2020-12-23",{"date":81,"type":21},"2030-12",{"name":43,"class":44},1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":83},"100532042","phase-2-study-to-evaluate-the-efficacy-and-safety-of-cetuximab-in-combination-with-encorafenib-plus-binimetinib-as-induction-treatment-in-braf-v600e-mutated-mss-initially-resectable-or-potentially-resectable-advanced-colorectal-cancer-100532042","NCT06207656","Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer","Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer","CEBBRA","Inclusion Criteria:\n\n* 1\\. Male or female participants age ≥18 years at the time of informed consent. 2. Capable of giving signed informed consent\u002Fassent. 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n\n  4\\. Participants with histologically or cytologically confirmed colorectal adenocarcinoma.\n\n  5\\. Presence of a BRAF V600E mutation confirmed as per standard of care according to international guidelines at any time prior to Screening.\n\n  6\\. Microsatellite stable (MSS) or Mismatch-Repair proficient (pMMR) disease confirmation assessed by local PCR or immunohistochemistry (IHC).\n\n  7\\. Participants with CRC who have one of these criteria:\n  1. Locally advanced colorectal cancer with initially unresectable but potentially resectable disease according to the local Multidisciplinary Tumour Board (MTB).\n  2. Oligometastatic colorectal cancer (possible metastasis sites: liver, lung, lymph nodes and peritoneum) with:\n\n  i. Initially resectable disease according to the local MTB or ii. Initially unresectable but potentially resectable disease according to the local MTB c. Stage II-IV colorectal cancer treated with previous neoadjuvant and\u002For adjuvant chemotherapy, for R0, if the shorter time from the resection or from the end of the adjuvant treatment to the relapse of colorectal cancer (possible metastasis sites: liver, lung, lymph nodes and peritoneum) is longer than 6 months. This relapse (locoregional and\u002For systemic) should be initially resectable or initially unresectable but potentially resectable disease according to the local MTB 8. ECOG performance status of 0 or 1. 9. Measurable or evaluable disease as assessed by investigator, according to RECIST v1.1.\n\n  10\\. Adequate bone marrow function characterized by the following at screening:\n  1. ANC ≥1.5 × 109\u002FL\n  2. Platelets ≥100 × 109\u002FL\n  3. Hemoglobin ≥9.0 g\u002FdL (with or without blood transfusions). 11. Adequate hepatic and renal function characterized by the following at screening:\n\n  \u003C!-- -->\n\n  1. Serum total bilirubin ≤1.5 x ULN. Note 1: Total bilirubin \\>1.5 x ULN is allowed if direct (conjugated) ≤1.5 x ULN and indirect (unconjugated) bilirubin is ≤4.25 x ULN.\n\n     Note 2: Participants with hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled following discussion and agreement with the medical monitor.\n  2. ALT and AST ≤2.5 × ULN, or ≤5 × ULN in the presence of liver metastases.\n  3. Adequate renal function defined by an estimated creatinine clearance ≥50 mL\u002Fmin according to the Cockcroft Gault formula or by 24-hour urine collection for creatinine clearance, or according to local institutional standard method.\n\n     12\\. Able to swallow, retain, and absorb oral medications.\n\n     Exclusion Criteria:\n* 1\\. Any medical or psychiatric condition including recent (within the past year) or current suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n  2\\. Leptomeningeal disease or brain metastases. 3. History of chronic inflammatory bowel disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to the start of study treatment.\n\n  4\\. Known RAS-mutant colorectal adenocarcinoma. 5. Impaired gastrointestinal function (e.g., uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, small bowel resection) or disease which may significantly alter the absorption of oral study intervention or recent changes in bowel function suggesting current or impending bowel obstruction.\n\n  6\\. Clinically significant cardiovascular diseases, including any of the following:\n  1. History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤6 months prior to the start of study treatment.\n  2. Congestive heart failure requiring treatment (New York Heart Association Grade ≥2).\n  3. History or presence of clinically significant cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia).\n  4. History of thromboembolic or cerebrovascular events ≤12 weeks prior to the start of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e., massive or sub-massive) deep vein thrombosis or pulmonary emboli.\n\n     Note 1: Participants with either deep vein thrombosis or pulmonary emboli that do not result in hemodynamic instability are allowed to enroll as long as they have been on a stable dose of anticoagulants for at least 4 weeks.\n\n     Note 2: Participants with thromboembolic events related to indwelling catheters (including PICC lines) or other procedures may be enrolled.\n  5. Triplicate average QTcF interval ≥480 ms or a history of prolonged QT syndrome.\n  6. Congenital LQTS. 7. Evidence of active non-infectious pneumonitis. 8. Evidence of active and uncontrolled bacterial or viral infection, with certain exceptions, as noted below, for chronic infection with HIV, hepatitis B or hepatitis C (please see below), within 2 weeks prior to start of study treatment.\n\n     9\\. Participants positive for HIV are ineligible unless they meet all of the following:\n\n  \u003C!-- -->\n\n  1. A stable regimen of highly active anti-retroviral therapy that is not contraindicated.\n  2. No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections.\n  3. A CD4 count \\>250 cells\u002FmcL, and an undetectable HIV viral load on standard PCR-based tests.\n\n     10\\. Active hepatitis B or hepatitis C infection\n\n  a. Active HBV is defined as any of the following:\n  1. HBsAg (+), HBV DNA \\>200 IU\u002FmL (105 copies\u002FmL);\n  2. HBsAg (+), HBV DNA ≤200 IU\u002FmL and persistent or intermittent elevation of ALT\u002FAST and\u002For liver biopsy showing chronic hepatitis with moderate or severe necroinflammation.\n\n     Note: Participants who are HBsAg (-), HBcAb (+) are eligible and should be monitored\u002Ftreated as per local standard of care.\n\n  b. Active HCV is defined as:\n  1. HCV antibody positive; AND\n  2. Presence of HCV RNA. 11. Concurrent or previous other malignancy within 3 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen's disease or prostate cancer with a Gleason score ≤6. Participants with other curatively treated malignancies with low risk of recurrence not listed may also be considered eligible after review and approval by the medical monitor.\n\n     12\\. Residual CTCAE≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy.\n\n     13\\. Previous treatment with any selective BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib, XL281\u002FBMS-908662) and\u002For any selective MEK inhibitor prior to screening.\n\n     14\\. Use of any prohibited medication (including herbal medication), supplement or food that is a moderate or strong inhibitor or inducer of CYP3A4\u002F5 ≤1 week prior to the start of study intervention.\n\n     15\\. Major surgery (e.g., inpatient procedure with regional or general anesthesia) or completion of radiation therapy ≤4 weeks prior to the start of study treatment.\n\n     16\\. Previous systemic anticancer therapy for CRC, with the following exceptions:\n\n     • Patients with resected (R0 or R1 resections) metastasis of CRC treated with or without adjuvant or neoadjuvant chemotherapy (+\u002F- antiEGFR or bevacizumab) would be includible if the time from the resection or from the end of the adjuvant treatment (the later) to the relapse of CRC were longer than 6 months\n\n     • Patients with previous adjuvant or neoadjuvant chemotherapy for resected St II\u002FIII CRC would be eligible if the time from the resection or from the end of the adjuvant treatment (the later) to the relapse of CRC were longer than 6 months 17. Prior systemic regimen in first line treatment for metastatic CRC in patients with unresectable or non-potentially resectable metastatic (M1) disease.\n\n     18\\. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).\n\n     19\\. Known contraindication to receiving cetuximab including hypersensitivity or toxicity that would suggest an inability to tolerate maximum cetuximab dose of 500 mg\u002Fm2.\n\n     20\\. Known sensitivity or contraindication to any component of study intervention or their excipients at the planned doses.\n\n     21\\. Pregnant, or is breastfeeding (lactating). 22. Male or female of childbearing age who do not agree with taking highly effective contraceptive precautions, (for definition, please refer to Appendix 15) or abstinence during the course of the study and for 6 months after the last administration of study drug for women and men.\n\n     23\\. Full dose radiotherapy \\\u003C28 days prior to the start of study treatment. Short course radiotherapy for local control of primary tumor or other palliative indication is allowed.\n\n     24\\. Patients with ulcerative keratitis.",{"count":93,"type":21},70,[95],"PHASE2","As a result of the little benefit obtained from standard treatments and the poor prognosis of these patients, the BRAF-V600E mutant MSS aCRC represents an unmet medical need requiring clinical research.\n\nThe combination of encorafenib, cetuximab and binimetinib as second- or third-line treatment for mCRC resulted in significantly better outcomes than standard therapy in a phase 3 clinical trial, which also revealed treatment safety and tolerability to be acceptable. Compared to the control group (cetuximab and irinotecan or cetuximab and FOLFIRI), the triplet therapy cohort showed higher median overall survival (9.3 vs. 5.9 months) and response rates (26.8% vs. 1.8%). Grade 3 adverse events occurred in 65.8% and 64.2% of patients for triple-therapy and control groups, respectively.\n\nBased on these results, the investigators speculated that the combination of encorafenib, cetuximab and binimetinib could be used as induction therapy to improve treatment outcomes in BRAF-V600E-mutated MSS aCRC locally advanced initially unresectable but potentially resectable; initially resectable or initially unresectable but potentially resectable oligometastatic disease; and in patients with stage II-IV who have relapsed after chemotherapy (neo and\u002For adjuvant) or surgery, if the shorter time after resection or from treatment end to relapse is longer than 6 months.",[98],"Colorectal Cancer",[100,101,102,103,104,105],"BRAF V600E mutated","MSS","advanced colorectal cancer","Cetuximab","Encorafenib","Binimetinib","2024-10-17",{"date":108,"type":37},"2024-10-21",{"date":110,"type":37},"2024-04-16",{"date":112,"type":21},"2029-04-01",{"name":43,"class":44},""]