[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oligometastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oligometastatic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100561689","phase-3-extending-outcomes-for-pancreas-cancer-patients-with-nominal-oligometastatic-disease-expand-a-randomized-phase-iii-trial-100561689",false,"NCT06593431","Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial","Inclusion Criteria:\n\nAge 18\n\nHistologically or cytologically confirmed pancreatic ductal adenocarcinoma.\n\nHistologic \u002F cytologic confirmation of pancreatic ductal adenocarcinoma may come from the primary tumor (i.e., via FNA at initial diagnosis). Histological\u002Fpathologic confirmation of distant metastatic disease is not required if clinical and radiographic consensus is that the patient has distant metastatic disease.\n\nEastern Cooperative Oncology Group (ECOG) performance status ≤2\n\nCandidate for MDT (including radiation therapy, surgical resection, ablation, and embolization) to all sites of disease including oligometastatic sites and if present intact primary \u002F regional nodal disease.\n\nBetween one and five distant metastatic lesions, counted as follows: each lesion (not site) will be counted as one, with the exception of metastatic lymph node stations, which will collectively count as one lesion. Regional nodal stations will be counted as a collective single lesion if present. All progressive lesions must be amenable to local therapy as noted in criterion 4.2.1.4 above.\n\nCounting of oligometastatic nodal disease will be based on nodal chains. A nodal chain will be considered a single metastatic lesion if the presence of that node results in the patient as having M1 disease per the TNM staging system, AJCC version 8.0. In addition, one of the following criteria must be met: a) ≥1 LN meets radiologic criteria for metastatic disease via RECIST 1.1 (short axis ≥15mm), b) pathologic assessment has confirmed the presence of metastatic cancer cells, and\u002For c) the LN exhibits imaging signal characteristic of a metastatic lesion (e.g. FDG avidity, contrast enhancement, etc.). In the event of ambiguity or equivocal findings, the principal investigator or co-principal investigator will make a final determination of whether criteria are met. The following caveats apply:\n\nIn patients with a LN exhibiting a short axis ≥15mm and who have other diagnoses that can produce enlarged LNs (e.g. indolent CLL, sarcoidosis, etc…) or a prior history of benign enlarged LNs will not be considered to have metastatic disease per the discretion of the treating physician.\n\nLN chains that occur bilaterally will be considered separate metastatic sites. For example, left axilla LNs will counted separately from right axilla LNs.\n\nThe following midline LN chains will be counted as 1 metastatic site: mediastinal, para-aortic, mesenteric.\n\nThe following bilateral LN chains will be counted as 1 metastatic site for unilateral involvement, and 2 for bilateral for involvement: preauricular, cervical and occipital, supraclavicular, infraclavicular, pectoral, axillary, hilar, epitrochlear and brachial, iliac, inguinal and femoral, popliteal.\n\nBaseline imaging must include a scan done within 4 weeks prior to randomization, demonstrating oligometastatic disease by RECIST (v1.1) criteria compared to pre-baseline imaging.\n\nBaseline imaging must be done within 4 weeks prior to randomization, and the following imaging is required: PET\u002FCT scan or CT scan of the chest\u002Fabdomen\u002Fpelvis. MRI may be substituted as indicated (i.e., CT scan of chest plus MRI abdomen\u002Fpelvis).\n\nDiagnostic laparoscopy may be indicated prior to enrollment if any concern for peritoneal disease \u002F carcinomatosis is present, at the investigator's discretion. Presence of peritoneal carcinomatosis will exclude the patient from this trial as below. Indications for peritoneal carcinomatosis may include findings concerning for but not definitive for peritoneal disease on diagnostic imaging, elevated CA-19-9, and clinical symptoms concerning for peritoneal disease.\n\nPatients referred for the study that require immediate MDT can receive treatment to CNS lesions or other symptomatic lesions prior to randomization, but these lesions will be counted towards the total number of oligometastatic lesions.\n\nPatients with \\>5 discrete metastatic sites previously with subsequent 'induction' of oligometastatic disease (\\<=5 discrete sites; induction via response to systemic therapy) may be eligible if 5 or fewer metastatic disease sites have been present \u002F noted radiographically for a minimum of 6 months, and pending principal investigator review\u002Fdiscretion.\n\nFemales of childbearing potential must not be breast feeding and must have a negative serum or urine pregnancy test and must agree to use adequate contraception from the time of screening until 3 months after discontinuation of the study medication. Acceptable methods of contraception include total and true sexual abstinence, tubal ligation, hormonal contraceptives that are not prone to drug-drug interactions (IUS Levonorgestrel Intra Uterine System (Mirena), Medroxyprogesterone injections (Depo-Provera), copper-banded intra-uterine devices, and vasectomized partner. All hormonal methods of contraception should be used in combination with the use of a condom by their sexual male partner. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Women will be considered post-menopausal if they have been amenorrheic for the past 12 months without an alternative medical cause. The following age-specific requirements must also apply: Women \\< 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of exogenous hormonal treatments. The levels of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) must also be in the post-menopausal range (as per the institution). Women ≥ 50 years old: they would be consider post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of all exogenous hormonal treatments, or have had radiation-induced oophorectomy with the last menses \\> 1 year ago, or have had chemotherapy-induced menopause with \\>1 year interval since last menses, or have had surgical sterilization by either bilateral oophorectomy or hysterectomy.\n\nNon-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and 6 months after the last dose of study medication. Adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide, cervical\u002Fvault cap or intrauterine device), and abstinence. Patients should not father a child for 6 months after completion of the study medication. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing the study medication. If male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of the study medication.\n\nDemonstration of adequate organ function as defined in the table below, all screening labs to be performed within 4 weeks prior to study enrollment:\n\nExclusion Criteria\n\nMetastatic effusion (e.g. pleural effusion or ascites). Note that patients with an effusion that is too small to sample will be eligible for the trial.\n\nLeptomeningeal disease.\n\nPeritoneal carcinomatosis.\n\nCognitively impaired subjects (e.g. inability to sign informed consent.)\n\nAny condition that, in the opinion of the investigator, would interfere with the study treatment or interpretation of the study results.\n\nDiffuse bone marrow involvement as defined by disease involvement of a BM biopsy from a site that does not have radiologic evidence of a bone metastasis.\n\nMore than 4 prior lines of systemic therapy to treat metastatic disease.\n\nDiagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe delivery of radiotherapy. Such patients may be eligible if dispositioned to non-radiotherapy MDT.\n\nKnown psychiatric or substance abuse disorder\u002Fs that would interfere with trial participation.\n\nConcurrent (synchronous or metachronous) other primary malignancy that in the opinion of the treating physician team presents a substantial risk to the patient's life as a competing risk of death (against the primary oligometastatic pancreatic cancer being considered for MDT as part of this trial).","ALL","18 Years",{"count":18,"type":19},80,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","The EXPAND trial (EXtending outcomes for PAncreas cancer patients with Nominal oligometastatic Disease) is a randomized phase III trial assessing the efficacy of MDT to improve PFS and OS for patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).",[25,26],"Pancreas Cancer","Oligometastatic","RECRUITING","2026-05-18",{"date":30,"type":31},"2026-05-20","ACTUAL",{"date":33,"type":31},"2024-10-23",{"date":35,"type":19},"2029-06-29",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",3,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":16,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100588516","phase-2-iparomlimab-and-tuvonralimab-with-chemoradiation-for-the-treatment-of-locally-recurrent-and-oligometastatic-cervical-cancer-100588516","NCT06942416","Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer","Phase II, Single-Arm, Multicenter Clinical Study of Iparomlimab and Tuvonralimab in Combination With Paclitaxel Plus Cisplatin\u002FCarboplatin and Radiotherapy for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer","Inclusion Criteria:\n\n1. Signed written informed consent prior to any trial-related procedures;\n2. Female, aged ≥18 and ≤75 years;\n3. ECOG PS 0-1;\n4. Histologically or cytologically confirmed primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial diagnosis, meeting clinical diagnostic criteria;\n5. Locally recurrent or oligometastatic cervical cancer after initial treatment. Total recurrent + metastatic lesions ≤5.Oligometastasis criteria:Lymph node metastases within the same region = 1 lesion;Liver metastases ≤1 lesion;Lung metastases ≤3 lesions\n6. At least one measurable lesion (including primary lesion) suitable for radiotherapy and evaluable per RECIST v1.1;\n7. Available tumor tissue sample for biomarker assessment;\n8. Expected survival ≥6 months;\n9. Normal organ function (within 7 days pre-enrollment):\n\n(1) Hematological criteria (no transfusion\u002Fgranulocyte\u002Fplatelet-stimulating drugs within 14 days):\n\n1. Hemoglobin (Hb) ≥80 g\u002FL\n2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL\n3. Platelets (PLT) ≥50×10⁹\u002FL (2) No functional organic disease:\n\na) ALT\u002FAST ≤2.5×ULN, total bilirubin ≤1.5×ULN, ALP ≤3×ULN, albumin ≥30 g\u002FL b) Serum Cr ≤1.5×ULN (if \\>1.5×ULN, CrCl ≥50 mL\u002Fmin by Cockcroft-Gault formula) c) PT prolongation ≤6 sec, APTT ≤1.5×ULN d) TSH ≤ULN (if abnormal, FT3\u002FFT4 must be normal) f) LVEF \\>50% 10. Prior anti-tumor treatment toxicities recovered to ≤Grade 1 (CTCAE v5.0) pre-treatment, excluding:\n\n* Alopecia\u002Fpigmentation (any grade)\n* Peripheral neuropathy (≤Grade 2)\n* Other toxicities where benefit-risk favors treatment 11. Non-sterilized\u002Fchildbearing-potential females must:\n* Use medical contraception (IUD\u002Foral contraceptives\u002Fcondoms) during treatment + 3 months post-treatment\n* Negative serum\u002Furine HCG within 7 days pre-enrollment\n* Non-lactating 12. Expected compliance with protocol follow-up following criteria:\n\n  1. Prior immunotherapy (e.g., immune checkpoint inhibitors);\n  2. Pathological diagnosis of gastric-type adenocarcinoma;\n  3. Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Exceptions: vitiligo; childhood asthma fully resolved without intervention in adulthood. Exclusion: asthma requiring bronchodilator therapy;\n  4. Current use of immunosuppressants or systemic\u002Fabsorbable topical corticosteroids (equivalent to \\>10 mg\u002Fday prednisone) for immunosuppression, continued within 2 weeks before enrollment;\n  5. History of Grade 3-4 immune-related adverse events (irAEs) associated with prior anti-tumor immunotherapy;\n  6. Poorly controlled cardiac conditions:\n\n  \u003C!-- -->\n\n  1. NYHA Class II or higher heart failure\n  2. Unstable angina\n  3. Myocardial infarction within 6 months\n  4. Clinically significant supraventricular\u002Fventricular arrhythmia requiring treatment\n  5. QTc \\>450 ms (males) or \\>470 ms (females); 7. Coagulation abnormalities (INR \\>1.5 or PT \\>16 s), bleeding tendency, or current thrombolytic\u002Fanticoagulant therapy; 8. Prior radiotherapy\u002Fchemotherapy\u002Fhormonal therapy\u002Fsurgery\u002Ftargeted therapy completed \\\u003C4 weeks before study treatment (or \\\u003C5 drug half-lives, whichever is longer); unresolved toxicities (excluding alopecia) from prior therapies \\>CTCAE Grade 1; 9. Poorly controlled third-space effusion requiring drainage before first trial drug administration; 10. Significant hemoptysis (≥2.5 mL\u002Fday) within 2 months before randomization; 11. Known hereditary\u002Facquired bleeding\u002Fthrombotic disorders (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism); 12. Active infection or unexplained fever \\>38.5°C during screening\u002Fbefore first dose; 13. Objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction; 14. Immunodeficiency (e.g., HIV infection) or active hepatitis:\n\n     * HBV DNA \\> upper limit of normal (ULN)\n     * HCV RNA \\> ULN; 15. Use of other investigational drugs within 4 weeks before first dose; radiotherapy\u002Flocal therapy within 2 weeks without full recovery; 16. Concurrent\u002Fprior malignancies (except cured basal cell carcinoma\u002Fcervical carcinoma in situ); 17. Planned concurrent systemic anti-tumor therapy during the study; 18. Live vaccination within 4 weeks before treatment or planned during the study; 19. Other conditions potentially requiring study termination per investigator judgment:\n     * Severe comorbidities (including psychiatric disorders) requiring treatment\n     * Critical lab abnormalities\n     * Social\u002Ffamily factors compromising safety or data\u002Fsample collection.","FEMALE","75 Years",{"count":50,"type":19},36,[52],"PHASE2","The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin\u002Fcarboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are:\n\n1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?\n2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?\n\nParticipants will:\n\n* Receive iparomlimab and tuvonralimab, Paclitaxel + Cisplatin\u002FCarboplatin and radiation therapy according to a specified protocol.\n* Visit the clinic for regular checkups and tests throughout the treatment period.\n* Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.\n* Provide hematologic、tissue and stool samples to explore biomarkers.\n\nThis study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic cervical cancer as well as identify biomarkers to better guide treatment strategies.",[55,56,26],"Cervical Cancer","Neoplasm Recurrence, Local",[58,59,60,61,62,63,64,65,66,67,68],"Immunotherapy","Paclitaxel","Cisplatin","Carboplatin","Radiation Therapy","Clinical Trials, Phase II as Topic","Progression-Free Survival","Biomarkers, Tumor","Treatment Outcome","Safety","Iparomlimab and Tuvonralimab","2025-04-16",{"date":71,"type":31},"2025-04-24",{"date":73,"type":31},"2025-02-28",{"date":75,"type":19},"2028-12-31",{"name":77,"class":38},"Shandong Cancer Hospital and Institute",1]