[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100619043","phase-2-intestinal-low-dose-radiotherapy-plus-immunochemotherapy-for-conversion-of-borderline-resectableunresectable-esophageal-squamous-cell-carcinoma-100619043",false,"NCT07339488","Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable\u002FUnresectable Esophageal Squamous Cell Carcinoma","Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy Plus Tislelizumab and Chemotherapy for Conversion of Borderline Resectable\u002FUnresectable Esophageal Squamous Cell Carcinoma","ILDR-03","Inclusion Criteria:\n\n1. Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance.\n2. Age ≥18 years and ≤75 years; both sexes are eligible.\n3. ECOG performance status score of 0-1.\n4. Pathologically confirmed esophageal squamous cell carcinoma (ESCC) prior to surgery.\n5. Thoracic esophageal cancer.\n6. Unresectable lesions, defined as: T4 stage; marginally resectable T3 stage (invading other organs, e.g., trachea, bronchus, or aorta not ruled out by imaging); presence or absence of unresectable lymph nodes or metastatic lymph nodes invading adjacent organs; presence or absence of supraclavicular lymph node metastasis; or clinically confirmed unresectable disease by the surgeon.\n7. No prior history of anti-tumor treatment, including chemotherapy, hormonal therapy, radiotherapy, or immunotherapy.\n8. Baseline laboratory requirements (within 7 days prior to enrollment):\n\n   Hematology:\n   1. Hb≥90 g\u002FL (no transfusion within 14 days)\n   2. NEUT ≥1.5×10⁹\u002FL\n   3. PLT ≥100×10⁹\u002FL\n   4. WBC≥3×10⁹\u002FL\n\n   Biochemistry:\n   1. ALT and AST≤2.5×ULN\n   2. TBIL≤1.5×ULN\n   3. SCr≤1.5×ULN; or CrCl≥60 mL\u002Fmin Coagulation: APTT, INR, and PT≤1.5×ULN Thyroid function: TSH≤ULN (if abnormal, FT3\u002FFT4 levels should also be considered; eligible if FT3\u002FFT4 are normal) Echocardiography: LVEF≥50%\n9. Female subjects need to agree to use contraception during the study and for 6 months post-study; serum pregnancy test negative within 7 days prior to enrollment; non-lactating. Male subjects must agree to use contraception during the study and for 6 months post-study.\n10. No psychological, familial, social, or geographical factors that may impair protocol adherence.\n11. Other parameters meet general clinical trial enrollment criteria.\n12. The subject or authorized representative has read, fully understands the patient information sheet, and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with distant metastases other than supraclavicular lymph node metastases.\n2. Presence or high risk of esophageal perforation.\n3. Patients with contraindications to radiotherapy or immune checkpoint inhibitor (ICI) therapy.\n4. Patients who previously experienced unacceptable toxicity after receiving ICI therapy.\n5. Patients with a history of thoracoabdominal\u002Fpelvic radiotherapy within 6 months prior to enrollment.\n6. Adverse reactions from prior anti-tumor treatment have not recovered to CTCAE v5.0 grade≤1 (excluding toxicities deemed by the investigator to pose no safety risk, such as fatigue or alopecia).\n7. Subjects with active, uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.\n8. Respiratory depression, airway obstruction, or tissue hypoxia.\n9. Severe cardiac disease (i.e., NYHA functional class II or higher).\n10. Markedly abnormal liver or kidney function (i.e., indicators \\>3 times the upper limit of normal).\n11. Active hepatitis B, hepatitis C, HIV, or syphilis.\n12. Active brain disease or central nervous system\u002Fmeningeal metastases with significant symptoms, or impaired decision-making capacity.\n13. Hypersensitivity to drugs included in the trial.\n14. Drug and\u002For alcohol abuse.\n15. Pregnant or lactating women.\n16. Concurrent participation in another therapeutic clinical trial.\n17. Major surgical procedure within 30 days prior to enrollment.\n18. Use of antibiotics, antifungals, antivirals, or antiparasitics within 4 weeks prior to registration.","ALL","18 Years","75 Years",{"count":21,"type":22},43,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Locally advanced EC (LAEC), particularly cases where radical surgical resection is not feasible, exhibits high recurrence rates and low 5-year survival rates. However, studies have shown that patients with LAEC who undergo comprehensive treatment followed by surgery experience significantly prolonged survival and improved quality of life compared to those who do not receive surgical intervention.\n\nCurrent conversion treatment regimens under investigation include: chemotherapy alone, chemoradiotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with chemoradiotherapy-each of these approaches has distinct advantages and limitations. Immunochemotherapy has emerged as a current research focus: it not only demonstrates significantly superior efficacy compared to chemotherapy alone but also exhibits lower cumulative toxicity than radiotherapy-combined conversion regimens, resulting in a more favorable overall benefit-risk ratio. As such, it represents the most promising conversion treatment strategy.\n\nRetrospective and prospective clinical studies have shown that low-dose radiotherapy targeting the small intestine can enhance the anti-tumor response of immune checkpoint inhibitors (ICIs) in patients with advanced solid tumor, prolong their overall survival, and increase the incidence of the abscopal effect. Further mechanistic investigations have revealed that intestinal low-dose radiotherapy (ILDR) may augment the immune cancerous lethality by modulating the gut microbiota and their metabolic profiles.\n\nBased on the findings from these preliminary studies, the current research plans to conduct a prospective phase II single-arm clinical trial to investigate the efficacy and safety of ILDR combined with immunochemotherapy as conversion therapy in patients with borderline resectable or unresectable esophageal squamous cell carcinoma (BR\u002FUR ESCC). This research plans to enroll at least 39 evaluable cases or a total of 43 cases in two seperated stages, focusing on patients with thoracic BR\u002FUR ESCC. Patients will receive a single fraction of ILDR with a mean dose of 1 Gy, concurrently with 3 cycles of albumin-bound paclitaxel (260 mg\u002Fm² on day 1), cisplatin (75 mg\u002Fm² on day 1), and tislelizumab (200 mg on day 1). The efficacy and safety of the treatment will be evaluated throughout the study.",[28,29,30,31,32,33,34],"Borderline Resectable Carcinoma","Unresectable Cancer","Esophageal Squamous Cell Carcinoma (ESCC)","Immune Checkpoint Inhibitor","Chemotherapy","Radiotherapy","Tislelizumab","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2025-12-05",{"date":43,"type":22},"2028-11-01",{"name":45,"class":46},"Chuangzhen Chen","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100625479","partial-tumor-irradiation-and-immunotherapy-for-unresectable-lung-cancer-100625479","NCT07423169","Partial Tumor Irradiation and Immunotherapy for Unresectable Lung Cancer","Rechallenge Using Combined Partial Tumor Irradiation and Immune Checkpoint Inhibitor-based Immunotherapy for Unresectable Lung Adenocarcinoma: a Pilot Study","Inclusion Criteria:\n\n1. Written informed consent\n2. Biopsy proven unresectable lung adenocarcinoma\n3. Ineligibility for surgery and conventional curative (whole tumor) radiotherapy, and relapsed\u002Frefractory to any previous standard of care therapy including ICI\n4. Age ≥ 18 years,\n5. Female patients must either be of non-reproductive potential (i.e. post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) OR women of fertile age must have adequate conception prevention measures and must have a negative serum pregnancy test upon study entry,\n6. Patient is willing and able to comply with the follow up including scheduled visits and examinations,\n7. Adequate immune blood profile (not being immunodepressed): Leucocyte count ≥4000, Neutrophils count ≥1000.\n8. PDL-1 ≥ 1%\n\nExclusion Criteria:\n\n1. Patients with resectable\u002Fcurable lung cancer\n2. Tumors suitable for the standard of care therapies including surgery or conventional curative (whole tumor) radio-chemotherapy\n3. Lung cancer histology other than adenocarcinoma\n4. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control\n5. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, (1)\n6. Patients with uncontrolled seizures.\n7. Inadequate immune blood profile (being potentially immunodepressed): Leucocyte count \\\u003C4000, Neutrophils count \\\u003C1000.\n8. PDL-1 \\\u003C 1%",{"count":56,"type":22},10,[58],"NA","The present study will explore a novel treatment strategy for unresectable lung adenocarcinoma combining a unique unconventional radiotherapy technique for high dose partial tumor irradiation (PTI) sparing the peritumoral immune microenvironment (PIM) with an immune checkpoint inhibitor (ICI)-based immunotherapy. The present study will focus on patients with larger, unresectable bulky lung tumors who previously failed standard of care therapy, or are unsuitable for conventional radio-chemotherapy due to tumor size and volume, and do not have any further therapeutic option left. This concept implies that a very high, ablative radiation dose (typically 20-25Gy per fraction) is delivered exclusively to the central bulky-tumor segment sparing at the same time surrounding PIM and therefore preserving its function.\n\nThe present study will explore the potential clinical advantages of the above described innovative treatment concept as a rechallenge treatment: following the disease progression during initiated first-line ICI-therapy, or following discontinuation of ICI-therapy, a same previously used agent (ICI) will be added the PTI to boost its immunologic anti-tumor effects. The treatment response will be measured by comparing the progression-free survival 1 (PFS-1) (ICI-therapy alone) and progression-free survival 2 (PFS-2) (combined rechallange PTI-ICI) rates.\n\nThe primary endpoint will be ∆PFS rate (PFS-2 vs PFS-1) assessed according to the modified iRECIST criteria. Secondary endpoints will include overall survival, toxicity, and exploration and validation of the anti-cancer immunity.\n\nOnce treatment is completed, follow up will be performed on a regular basis (at 6 and 12 weeks, and every 3 months later on) by CT, MRT or PET-CT imaging to allow for endpoints assessment, or at any time in case of suspected disease progression. Patients will also be followed clinically with history and physical examinations, vital signs, and laboratory examinations as indicated.",[61,62,29],"Lung Adenocarcinoma","Bulky Tumors",[64,65,66],"Partial Irradiation","Immunomodulation","Radio-Vaccine","2026-02-18",{"date":69,"type":39},"2026-02-20",{"date":71,"type":39},"2026-02-02",{"date":73,"type":22},"2028-02",{"name":75,"class":46},"Karl Landsteiner University of Health Sciences"]