[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-pancreatic-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-pancreatic-adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,74,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"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},"100643738","phase-1-peptide-nanovaccine-onvax-01-plus-anti-pd-1-antibody-and-chemotherapy-in-advanced-pancreatic-cancer-100643738",false,"NCT07637786","Peptide Nanovaccine (ONVAX-01) Plus Anti-PD-1 Antibody and Chemotherapy in Advanced Pancreatic Cancer","An Exploratory Clinical Study of Peptide Nanovaccine (ONVAX-01) and Anti-PD-1 Antibody Combined With Chemotherapy for the Treatment of Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* • Age between 18 and 75 years (inclusive).\n\n  * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  * Histologically confirmed, KRAS-mutated, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).\n  * Documented disease progression after at least one prior line of systemic therapy.\n  * Estimated life expectancy of ≥ 12 weeks.\n  * At least one measurable objective tumor lesion according to RECIST v1.1. The maximum diameter must be ≥ 1 cm by spiral CT, or ≥ 2 cm by standard CT or MRI; imaging must be performed within 28 days prior to enrollment.\n  * Adequate bone marrow and organ function, defined as follows (without the use of hematopoietic growth factors or blood transfusions within 7 days prior to testing):\n\n    * Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 75 × 10\\^9\u002FL, and hemoglobin ≥ 90 g\u002FL.\n    * Hepatic: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.\n    * Renal: Creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n    * Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.\n    * Cardiac: Normal electrocardiogram (ECG) or abnormal ECG deemed clinically insignificant by the investigator.\n    * Urinalysis: Urine protein \\\u003C 2+; if urine protein is ≥ 2+, a 24-hour urine protein quantification must be \\\u003C 1.0 g.\n  * Participants of childbearing potential must agree to use highly effective contraceptive measures from study entry throughout the study period.\n  * Participants with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have received at least 14 days of continuous antiviral therapy prior to the first study dose. HBV DNA titer must be ≤ 500 IU\u002FmL (or 2500 copies\u002FmL) and HCV RNA must be below the lower limit of detection. Participants must be willing to continue effective antiviral therapy during the study.\n\nExclusion Criteria:\n\n* • Receipt of anti-tumor chemotherapy, radiotherapy, or immunotherapy within 2 weeks prior to the first dose of the study vaccine.\n\n  * History of other malignancies, except adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, non-muscle invasive bladder cancer (Ta and TIS), or other malignancies curatively treated at least 5 years prior to enrollment.\n  * Uncontrolled concomitant diseases, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias.\n  * Prior treatment with any antibody or drug targeting T-cell co-regulatory proteins (immune checkpoints), such as anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137, anti-TIM-3, or anti-LAG-3 antibodies.\n  * Human Immunodeficiency Virus (HIV) infection, or active uncontrolled HBV (HBV DNA ≥ 500 IU\u002FmL) or HCV infection.\n  * Uncontrolled coronary artery disease, asthma, cerebrovascular disease, or any other medical conditions deemed unsuitable for enrollment by the investigator.\n  * Active autoimmune disease, primary or secondary immunodeficiency, or current treatment with immunosuppressive medications.\n  * Pregnant or lactating women.\n  * Receipt of any prophylactic vaccines for infectious diseases within 4 weeks prior to the first dose, or planned vaccination during the study up to 8 weeks after the last dose.\n  * History of severe allergic reactions to prior prophylactic vaccines.\n  * Known allergy or hypersensitivity to the investigational drugs or any of their excipients.\n  * History of substance abuse, or any clinical, psychological, or social factors that would preclude the administration of immunotherapy.\n  * Significant weight loss (≥ 10% of body weight) within 6 weeks prior to enrollment.\n  * Any other condition or uncertainty that, in the investigator's judgment, could compromise patient safety or compliance with the study protocol.","ALL","18 Years","75 Years",{"count":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to evaluate the safety and preliminary effectiveness of a new combination therapy in patients with advanced pancreatic cancer.\n\nThe main questions it aims to answer are:\n\n1. Is the combination of the peptide nanovaccine (ONVAX-01), an anti-PD-1 antibody, and chemotherapy safe and well-tolerated?\n2. Does this combination treatment help shrink tumors or stop the progression of advanced pancreatic cancer?\n\nParticipants will be asked to:\n\n1. Receive doses of the peptide nanovaccine (ONVAX-01).\n2. Receive intravenous infusions of an anti-PD-1 antibody and standard chemotherapy.\n3. Undergo regular physical exams, blood tests, and imaging scans (such as CT or MRI) to monitor their health and the tumor's response to the treatment.",[27],"Advanced Pancreatic Adenocarcinoma",[29,30,31,32],"Advanced pancreatic adenocarcinoma","Anti-PD-1 Antibody","Peptide Nanovaccine","Chemotherapy","NOT_YET_RECRUITING","2026-06-09",{"date":36,"type":37},"2026-06-10","ACTUAL",{"date":39,"type":21},"2026-06-20",{"date":41,"type":21},"2029-09-01",{"name":43,"class":44},"Sichuan University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100423102","phase-1-nano-smart-nanoparticles-with-mr-guided-sbrt-in-centrally-located-lung-tumors-and-pancreatic-cancer-100423102","NCT04789486","Nano-SMART: Nanoparticles With MR Guided SBRT in Centrally Located Lung Tumors and Pancreatic Cancer","Nano-SMART: An Adaptive Phase I-II Trial of AGuIX Gadolinium-based Nanoparticles With Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Centrally Located Lung Tumors and Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\nPatients should have clinical, radiographical, cytological, or histological confirmation of NSCLC or lung or nodal metastases from another primary cancer defined as within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi). Tumors that are immediately adjacent (\\\u003C1 cm) to mediastinal or pericardial pleura or other radiation-sensitive organs such as the esophagus and brachial plexus also are considered central tumors and are eligible for this protocol.\n\nOR Histologically or cytologically confirmed pancreatic ductal adenocarcinoma of the pancreatic head, body or tail.\n\n* Participants must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.\n\nEligible NSCLC patients must have no evidence of nodal involvement (N0), and disease has to be determined unresectable by a thoracic oncologist or the patient is medically inoperable.\n\n* Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at the investigative site, including multi-phasic CT demonstrating tumor abutment of the SMA or celiac axis, SMV or PV involvement which is not resectable without vascular reconstruction.\n* Completion of at least 3 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX, gemcitabine and nab-paclitaxel, or another standard combination of induction chemotherapy agent, with a washout period no longer than 10 weeks prior to first dose of study drug.\n* No evidence of distant metastasis.\n* Pancreatic or central NSCLC size ≤ 5cm.\n* Age 18 years or older.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Ability to understand and follow the breathing instructions involved in the respiratory gating procedure.\n* Participants must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional upper limit of normal\n  * creatinine within normal institutional limits OR\n* Creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n* The effects of AGuIX on the developing human fetus are unknown. For this reason, as well as the known teratogenic effects of radiation, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had prior radiation therapy to the chest or abdomen that would overlap with the current treatment field.\n* Participants who are receiving any other investigational agents.\n* Participants with known metastatic disease.\n* History of allergic reactions attributed to gadolinium-based IV contrast.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because AGuIX is contrast agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AGuIX, breastfeeding should be discontinued if the mother is treated with AGuIX.\n* Severe claustrophobia or anxiety.\n* Known HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AGuIX. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.\n* Active duodenal or gastric ulcer disease or evidence of tumor invasion of the bowel or stomach based on endoscopy.\n* Presence of a duodenal stent.\n* Unable to undergo magnetic resonance imaging (MRI) due to any of the following:\n\n  1. Presence of MRI-incompatible metal material or devices in the human body\n  2. MRI-incompatible Pacemaker or defibrillator\n  3. Insulin pump\n  4. Aneurysm clip\n  5. Artificial heart valve\n  6. Cochlear implant\n  7. Shrapnel or gunshot injury\n  8. Cataract surgery with implant unsafe for MRI",{"count":54,"type":21},100,[24,56],"PHASE2","This research study is being done to help determine the safety and efficacy of gadolinium based nanoparticle, Activation and Guidance of Irradiation X (AGuIX), used in conjunction with MR-guided stereotactic body radiation therapy (SBRT) in the treatment of pancreatic cancer and lung tumors.",[59,27,60,61],"Non-small Cell Lung Cancer","Unresectable Pancreatic Cancer","Ductal Adenocarcinoma of the Pancreas",[59,27,60,61],"RECRUITING","2026-05-12",{"date":66,"type":37},"2026-05-14",{"date":68,"type":37},"2021-05-27",{"date":70,"type":21},"2030-04-10",{"name":72,"class":44},"Dana-Farber Cancer Institute",2,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100550999","phase-1-gemcitabine-and-leflunomide-in-patients-with-advanced-unresectable-pancreatic-cancer-100550999","NCT06454383","Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer","A Phase 1b Study of Gemcitabine and Leflunomide in Patients With Unresectable Pancreatic Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Adult patients lacking capacity to consent may participate if they have a caretaker that could ensure oral medication compliance.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies.\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval.\n* Age: ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1.\n* Subjects must have histologically or cytologically confirmed diagnosis of advanced unresectable pancreatic ductal adenocarcinoma (PDA).\n* Measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1\n* Potential patients must have plans of receiving single agent gemcitabine.\n* Fully recovered from the acute toxic effects (except alopecia or neuropathy) to ≤ grade 1 to prior anti-cancer therapy.\n* Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3 NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement.\n* Without bone marrow involvement: Platelets ≥ 100,000\u002Fmm\\^3 NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement.\n* Hemoglobin ≥ 9g\u002FdL NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement.\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 x ULN (unless has Gilbert's disease total bilirubin ≤ 3 x ULN)\n* Aspartate aminotransferase (AST) ≤ 1.5 x ULN OR if liver metastases ≤ 3 x ULN\n* Alanine aminotransferase (ALT) ≤ 1.5 x ULN OR if liver metastases ≤ 2 x ULN\n* Creatinine ≤ 1.5 x ULN OR creatinine clearance (Cockcroft Gault) of ≥ 50 mL\u002Fmin for participants with a creatinine level of \\> 1.5 x ULN.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of gemcitabine therapy for women and at least 3 months after the last dose of gemcitabine therapy for men, and\u002For undergo drug elimination of leflunomide at end of treatment until leflunomide is undetectable in the plasma.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.\n* Drugs metabolized by CYP2C8, CYP1A2, BCRP, OATP1B1\u002FB3, and OAT3 transporters within 21 days prior to day 1 of protocol therapy.\n* Herbal medications (excluding cannabidiol \\[CBD\\]).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Issues with tolerating oral medication (e.g. inability to swallow pills, malabsorption issues, ongoing nausea or vomiting).\n* Positive for tuberculosis or latent tuberculosis (TB).\n* Active diarrhea.\n* Clinically significant uncontrolled illness.\n* Active infection requiring antibiotics.\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection. (\\*If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.)\n* Diagnosis of Gilbert's disease.\n* Prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or more years prior to study entry with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score ≤ 6 = Gleason group 1) localized prostate cancer will be eligible even if diagnosed less than 5 years prior to study entry. Other malignancies with low probability of recurrence may be allowed with PI approval.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":82,"type":21},19,[24],"This phase Ib trial tests the safety, side effects, and best dose of leflunomide in combination with gemcitabine in treating patients with pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and cannot be removed by surgery (unresectable). Improving the effectiveness of gemcitabine without increasing side effects could lead to a greater impact for pancreatic cancer patients' survival and quality of life. Gemcitabine is commonly used as a first-line chemotherapy treatment for pancreatic cancer. Leflunomide is a drug approved for use against rheumatoid arthritis that is being looked at as a cancer treatment option. It has shown promising results when combined with gemcitabine. Giving gemcitabine in combination with leflunomide may be safe and effective in treating patients with advanced unresectable pancreatic cancer.",[27,86,87,88],"Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Unresectable Pancreatic Ductal Adenocarcinoma","2026-04-10",{"date":91,"type":37},"2026-04-13",{"date":93,"type":37},"2024-05-13",{"date":95,"type":21},"2026-11-13",{"name":97,"class":44},"City of Hope Medical Center",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100521733","lotus-cc-an-observational-research-study-to-uncover-subtypes-of-cancer-cachexia-100521733","NCT06073431","LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia","Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia","LOTUS","Inclusion Criteria:\n\n* Have a primary diagnosis of unresectable or stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer\n\n  * Note: Patients do not need to have cachexia to be eligible\n* Plan to start first-line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, interventional clinical trial) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.\n\n  * NOTE: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant treatment and have since recurred are still eligible if such treatment ended \\> 6 months prior to enrollment. Patients receiving concurrent radiation with systemic therapy or received local therapy alone (surgery, radiation therapy \\[RT\\]) prior to first line therapy remain eligible. Patients receiving maintenance treatment after first line therapy are not eligible\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Be able to understand, speak and read English\n* Be 18 years of age or older\n\nExclusion Criteria:\n\n* Have contraindications to physical function assessments (30-second arm curl, Timed-Up-And-Go test, or 30-second chair-stand test) per the treating provider or their designee\n* Have any planned major surgeries within the next 3 months\n* Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than early local staged non-melanoma skin cancer\n* Be pregnant",{"count":107,"type":21},800,"OBSERVATIONAL","This study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.",[111,112,27,113,114,87,115,116,117],"Advanced Colorectal Carcinoma","Advanced Lung Non-Small Cell Carcinoma","Stage IV Colorectal Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Unresectable Colorectal Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Pancreatic Adenocarcinoma","2026-01-07",{"date":120,"type":37},"2026-01-09",{"date":122,"type":37},"2023-12-04",{"date":124,"type":21},"2028-09-30",{"name":126,"class":44},"University of Rochester",225]