[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-cancer-adenocarcinoma-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-cancer-adenocarcinoma-metastatic":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,55,79,105,134,162,188,209],{"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":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100576736","phase-1-a-phase-1-first-in-human-study-of-okn4395-and-pembrolizumab-in-patients-with-solid-tumors-100576736",false,"NCT06789172","A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors","A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors","INVOKE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed disease, locally advanced or metastatic:\n\n   For Phase 1a:\n\n   Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.\n\n   For Phase 1b:\n\n   For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted\n   * Cohort 1: Sarcoma (fibrous sarcoma \\[myxofibrosarcoma or solitary fibrous tumor\\], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.\n   * Cohort 2: NSCLC (squamous or adenomatous without EGFR\u002FALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.\n   * Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.\n   * Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy cessation.\n2. ECOG performance status of 0 or 1.\n3. Recovery from any medically relevant AE\u002FirAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs \\[not worsened to Grade \\>2 for \\>3 months prior to screening\\]).\n4. One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year \\[Phase 1a\\], or within 90 days and after the last administration of the previous systemic therapy \\[Phase 1b\\] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).\n5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators\u002Fradiologists.\n6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.\n7. The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition known to affect upper gastrointestinal motility, absorption, and pH.\n8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):\n\n   1. Hematological variables: absolute neutrophil counts ≥1.5 × 109 \u002FL, platelet counts ≥75 × 109 \u002FL, and hemoglobin ≥8 g\u002FdL\n   2. Renal variables: creatinine clearance ≥ 60 mL\u002Fmin1 by Du Bois \\& Du Bois formula\n   3. Hepatic variables: total serum bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, and ALP ≤2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin ≤5× ULN and direct bilirubin ≤1.5 x ULN)\n   4. Serum albumin ≥30 g\u002FL\n\nExclusion Criteria:\n\n1. Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:\n\n   1. Chemotherapy, ADCs, or other antibodies \\\u003C 21 days\n   2. Immunotherapy or cellular therapy \\\u003C 28 days\n   3. Radiation therapy (palliative radiation for bone pain \\\u003C48 hours; stereotactic or small field brain irradiation \\\u003C7 days; all other radiation therapy \\\u003C14 days)\n   4. TKI or any other anticancer therapy \\\u003C 5 half-lives or \\\u003C 7 days, whichever is longer\n2. Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies \\[including low dose steroids\\]).\n3. Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.\n4. Unstable COPD defined as frequent or severe exacerbations per investigator discretion.\n5. Known history of or active HBV (HBsAg reactive and\u002For HBV DNA detected) or HCV (HCV RNA detected) infection.\n6. HIV infection with CD4 lymphocyte count \\\u003C350 cells\u002FμL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level \\\u003C 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening.\n7. Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and\u002For aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.\n8. Known H. pylori infection without proof of eradication at least 2 months prior to screening.\n9. Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for more than 2 weeks prior to discontinuation, discontinuation should occur at least 21 days before first dose of OKN4395.\n10. Acute treatment with any systemic steroid therapy (\\>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.\n11. For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.\n12. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg\u002Fday, or 325 mg ≤ 3 times\u002Fweek is permitted).\n13. Systemic treatment with strong inhibitors\u002Finducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.\n14. QTcF interval of \\> 450 ms based on mean of the central triplicate readings.\n15. Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).\n16. Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).\n17. Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).\n18. History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate","ALL","18 Years",{"count":20,"type":21},146,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.\n\nThe overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.\n\nThis study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.\n\nPart 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.\n\nThe overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.\n\nThe study will be conducted in the US, Australia, UK and in the EU.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Solid Tumours","Sarcoma","HNSCC","Non Small Cell Lung Cancer","NSCLC","Colorectal Cancer (CRC)","Myxofibrosarcoma (MFS)","Solitary Fibrous Tumors","Dedifferentiated Liposarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Leiomyosarcoma","Leiomyosarcoma (LMS)","Gastric Cancer (GC)","Gastric Cancer Adenocarcinoma Metastatic","Gastric \u002F Gastroesophageal Junction Adenocarcinoma","RECRUITING","2026-06-09",{"date":45,"type":46},"2026-06-11","ACTUAL",{"date":48,"type":46},"2025-01-23",{"date":50,"type":21},"2028-09",{"name":52,"class":53},"Epkin","INDUSTRY",10,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100623108","phase-2-safety-and-efficacy-of-fruquintinib-plus-nab-paclitaxel-and-iparomlimab-and-tuvonralimab-injection-in-the-second-line-treatment-for-immunotherapy-experienced-advanced-gastric-cancer-100623108","NCT07392346","Safety and Efficacy of Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection in the Second-Line Treatment for Immunotherapy-experienced Advanced Gastric Cancer","A Prospective, Single-Arm, Phase Ⅱ Clinical Trial Evaluating Fruquintinib in Combination With Paclitaxel for Injection (Albumin-bound) and Iparomlimab and Tuvonralimab Injection as Second-Line Therapy in Advanced Gastric Cancer Patients Previously Received Immunotherapy","Inclusion Criteria:\n\n1. ≥ 18 years\n2. Pathologically or cytologically confirmed diagnosis of gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.\n3. Failure of first-line treatment with PD-1\u002FPD-L1 inhibitors\n4. With measurable lesions according to RECIST 1.1 criteria.\n5. ECOG performance status of 0-1\n6. Expected survival ≥3 months;\n7. Major organ functions meet the following requirements :\n\n   * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (no growth factors used within 14 days).\n   * Platelet count (PLT) ≥ 100,000\u002Fmm³ (100 × 10⁹\u002FL) (no correction therapy used within 7 days).\n   * Hemoglobin (Hb) ≥ 9 g\u002FdL (90 g\u002FL) (no correction therapy used within 7 days).\n   * Serum creatinine ≤ 1.5 × upper limit of normal (ULN).\n   * Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN).\n   * Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) levels ≤ 2.5 × upper limit of normal (ULN); ≤ 5 × upper limit of normal (ULN) for patients with liver metastases.\n   * Urinalysis is normal, or urine protein \\\u003C (++), or 24-hour urine protein level \\\u003C 1.0 g.\n8. Normal coagulation function, with no history of active bleeding or thrombotic diseases:\n\n   * International normalized ratio (INR) ≤ 1.5 × ULN.\n   * Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n   * Prothrombin time (PT) ≤ 1.5 × ULN.\n9. For patients with potential fertility, the following requirements must be met:\n\n   * Adopt a medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 3 months after the completion of study treatment.\n   * Serum human chorionic gonadotropin (β-HCG) test must be negative within 72 hours prior to study enrollment.\n   * Must not be breastfeeding.\n10. Patients must have provided written informed consent, and be willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. History of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose of study medication.\n2. Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage.\n3. Hypersensitivity to any component of monoclonal antibodies, fruquintinib, or albumin-bound paclitaxel.\n4. Receipt of any of the following treatments:\n\n   1. Severe adverse reactions to prior immunotherapy.\n   2. Prior treatment with CTLA4 inhibitors.\n   3. Any study medication within 4 weeks prior to the first dose of study medication.\n   4. Concurrent enrollment in another clinical study (excluding observational studies or survival follow-ups of interventional studies).\n   5. Last dose of anti-cancer therapy ≤ 3 weeks prior to the first study medication, or fixed-field palliative radiotherapy ≤ 2 weeks prior to study intervention.\n   6. Corticosteroid use (\\>10 mg prednisone equivalent\u002Fday) within 2 weeks prior to study medication; the investigator may decide on eligibility in special cases. Inhaled\u002Ftopical steroids and adrenal replacement at \\>10 mg\u002Fday prednisone equivalent are permitted in the absence of active autoimmune diseases.\n   7. Anti-tumor vaccines or live vaccines within 4 weeks prior to study medication.\n   8. Major surgery or severe trauma within 4 weeks prior to study medication.\n5. Previous anti-tumor treatment toxicities not recovered to ≤ CTCAE Grade 1 (excluding alopecia) or the specified inclusion\u002Fexclusion criteria levels.\n6. Central nervous system metastases.\n7. History of active autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) or a history of such diseases (excluding vitiligo, or childhood asthma\u002Fallergies cured and requiring no intervention in adulthood; autoimmune hypothyroidism on stable thyroid replacement; type 1 diabetes on stable insulin).\n8. Immunodeficiency history (including HIV-positive status, acquired\u002Fcongenital immunodeficiency, organ transplantation, or allogeneic bone marrow transplantation).\n9. Inadequately controlled cardiovascular symptoms\u002Fdiseases, including: (1) NYHA Class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular\u002Fventricular arrhythmias (uncontrolled with clinical intervention).\n10. Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein \\>1.0 g.\n11. Abnormal coagulation (INR \\>1.5×ULN or PT \\>ULN+4s), with bleeding tendency or thrombolytic\u002Fanticoagulant therapy (small-dose low-molecular-weight heparin or oral aspirin for prophylaxis permitted during the trial).\n12. Significant clinical bleeding or definite bleeding tendency within 3 months (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis). If baseline occult blood in stool is positive, re-testing is allowed; endoscopy may be performed based on clinical judgment if positive after re-testing.\n13. Active ulcers, unhealed wounds, or fractures.\n14. Hypertension inadequately controlled by anti-hypertensive medication (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg).\n15. Severe infection (CTCAE \\>Grade 2) within 4 weeks prior to study medication (e.g., severe pneumonia, bacteremia, infectious complications requiring hospitalization); baseline chest imaging showing active pulmonary inflammation, or infection symptoms\u002Fsigns requiring oral\u002FIV antibiotics within 2 weeks prior to study medication (excluding prophylactic antibiotics).\n16. History of interstitial lung disease (excluding radiation pneumonitis or non-infectious pneumonitis not treated with steroids).\n17. Active tuberculosis (confirmed by history\u002FCT) or history of active tuberculosis within 1 year prior to enrollment, or untreated active tuberculosis more than 1 year prior to enrollment.\n18. History of any other malignant tumor within 5 years prior to study medication (excluding low-risk tumors with \\>90% 5-year survival rate, e.g., adequately treated basal cell\u002Fsquamous cell skin cancer or cervical intraepithelial neoplasia).\n19. Pregnant or breastfeeding women.\n20. Other factors (e.g., concurrent severe diseases including mental illness, severely abnormal lab values, family\u002Fsocial factors) that may lead to forced withdrawal from the study, as determined by the investigator.",{"count":63,"type":21},68,[65],"PHASE2","Immunotherapy has established the new standard for first-line treatment of advanced or metastatic gastric cancer. However, current second-line options-predominantly consisting of targeted therapy plus chemotherapy or chemotherapy alone-confer only modest clinical benefit. Notably, pivotal phase III second-line trials (REGARD, RAINBOW, RAINBOW-Asia, FRUTIGA) exclusively enrolled patients who progressed on chemotherapy regimens; thus, high-quality evidence guiding second-line treatment specifically for immunotherapy-refractory patients remains scarce, representing a significant unmet medical need.\n\nAnti-angiogenic agents have demonstrated capacity to ameliorate the hypoxic, immunosuppressive tumor microenvironment while exerting synergistic anti-tumor effects when combined with immune checkpoint inhibitors. Exploratory studies evaluating immunotherapy combined with anti-angiogenic therapy plus chemotherapy in advanced gastric cancer patients after first-line failure have yielded encouraging efficacy signals (NCT03966118, NCT04982276), with objective response rates of 30-40% and median progression-free survival approaching 6 months.\n\nBased on this, the investigators aim to evaluate the efficacy and safety profile of fruquintinib combined with nab-paclitaxel and Iparomlimab and Tuvonralimab Injection (a novel bispecific antibody) as second-line treatment for patients with advanced gastric cancer who have experienced disease progression during or after first-line immunotherapy-containing regimens.",[40],"2026-02-09",{"date":70,"type":46},"2026-02-11",{"date":72,"type":46},"2025-12-01",{"date":74,"type":21},"2028-11-30",{"name":76,"class":77},"Dai, Guanghai","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100586934","phase-1-a-first-in-human-study-using-bdc-4182-as-a-single-agent-in-advanced-gastric-and-gastroesophageal-cancer-100586934","NCT06921837","A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer","A Phase 1\u002F2, First-in-Human, Dose Escalation and Expansion Study of BDC-4182 as a Single Agent in Patients With Advanced Gastric and Gastroesophageal Cancer","Key Inclusion Criteria:\n\n* Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.\n* Subjects must have histologically\u002Fcytologically confirmed gastric or gastroesophageal cancer that is metastatic (Stage 4) or unresectable (Stage 3).\n* Subjects must have received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies.\n* For subjects in escalation: If prior Claudin 18 IHC expression is known, the subject must have some degree of Claudin 18 expression as defined as Positive or have expression ≥ 1% of tumor cells IHC ≥ 2+. Consult with Medical Monitor as needed.\n* Adequate organ function\n* Agree to have a biopsy prior to enrollment, at acceptable risk in the judgement of the Investigator. If a biopsy is not safely accessible or clinically feasible, an adequate archival tumor sample must be submitted.\n\nKey Exclusion Criteria:\n\n* Known central nervous system (CNS) metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 14 days before starting study treatment.\n* Cardiac disease, pulmonary disease, or hepatic disease\n* Active infection\n* History of inflammatory eye disease\n* Residual toxicity from a previous treatment\n* Any investigational agent or standard anti-cancer therapies within 28 days before starting study treatment or within 5 estimated elimination half-lives, whichever is shorter.",{"count":87,"type":21},122,[24,65],"A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers",[40,91],"Gastroesophageal Adenocarcinoma",[93,94],"Gastric Cancer","Gastroesophageal Cancer","2026-01-23",{"date":97,"type":46},"2026-01-27",{"date":99,"type":46},"2025-05-26",{"date":101,"type":21},"2029-05",{"name":103,"class":53},"Bolt Biotherapeutics, Inc.",16,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100590032","phase-2-phase-ii-rainspot-zolbetuximab-paclitaxel-ramucirumab-for-cldn182-positive-gastro-esophageal-cancer-100590032","NCT06962137","Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer","Phase II RAINSPOT: a Multicentric Open Label Trial of Zolbetuximab-Paclitaxel-Ramucirumab in Second Line Setting for CLDN18.2 Positive Gastro-esophageal Adenocarcinoma","RAINSPOT","Inclusion Criteria:\n\n1. At least 18 years of age at the time of ICF\n2. WHO performance status 0 - 1\n3. Histologically proven metastatic gastroesophageal adenocarcinoma\n4. Pretreatment with one 1st line therapy according to SOC (+\u002F- immunotherapy)\n5. If relapse while adjuvant (immune\u002Fchemo) therapy or within 6 months ending adjuvant therapy the adjuvant therapy is considered a first line therapy\n6. CLDN18.2-positive (defined as ≥75% of tumour cells showing moderate-to-strong membranous CLDN18.2 staining, as determined by immunohistochemistry using the VENTANA CLDN18 \\[43-14A\\] RxDx Assay.\n7. Any PDL1 score\n8. Use of highly effective methods of birth control\n9. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n\nExclusion Criteria:\n\n\\- 1. Metastatic squamous cell cancer of the esophagus 2. Absolute contra-indication for anti-VEGF inhibitors (tumor perforation, active proteinuria, recent stroke, myocardial infarction, acute arterial thrombosis, active wound problem) 3. Other active malignancy 4. Pretreatment with Zolbetuximab or other anti-CLDN18.2 direct therapy in first line setting once available.\n\n5\\. Known hypersensitivity to the active substance Zolbetuximab or to any of the excipients \\[(Arginine, Phosphoric acid (E 338), Sucrose, Polysorbate 80 (E 433)\\] 6. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 7. Participation in another interventional Trial with an investigational medicinal product (IMP) or device",{"count":114,"type":21},100,[65],"This study examines whether adding the drug Zolbetuximab to an existing treatment (Paclitaxel and Ramucirumab) can improve patients' survival. The goal is to see if this combination works better for patients whose tumours contain a specific protein (CLDN18.2). The results will be compared to past patient data from those who only received the standard treatment.\n\nZolbetuximab (Vyloy) is a cancer medicine that is used to treat adults with gastric or gastro-esophageal junction adenocarcinoma (a type of cancer of the stomach or the transition between the stomach and esophagus). Zolbetuximab will be administered via an intravenous infusion in combination with Paclitaxel and Ramucirumab (Cyramza) (two other cancer drugs that are the standard treatment for this condition). Treatment will take place at regular intervals in the hospital. In addition to treatment,patients will undergo a tumour biopsy. While the biopsy procedure may cause some discomfort or pain, it will only be performed if medically justifiable. Patients participation in the study will continue as long as they receive treatment and the disease does not worsen. The overall duration of the study, for all patients, will span several years.",[40,118],"Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma",[120,121,122,123],"Zolbetuximab-Paclitaxel-Ramucirumab","second line","CLDN18.2 positive","gastro-esophageal adenocarcinoma","2025-12-15",{"date":126,"type":46},"2025-12-22",{"date":128,"type":46},"2025-12-11",{"date":130,"type":21},"2030-08-30",{"name":132,"class":77},"Universitaire Ziekenhuizen KU Leuven",6,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":141,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":78},"100604405","phase-1-lenvatinib-in-combination-with-nivolumab-plus-chemotherapy-in-metastatic-gastric-cancer-patients-with-malignant-ascites-100604405","NCT07149090","Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites","A Clinical Trial Evaluating the Efficacy and Safety of Lenvatinib, Nivolumab, and Chemotherapy in Metastatic Gastric Cancer With Malignant Ascites.","Inclusion Criteria:\n\n1. Newly diagnosed pathologically proven metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma\n2. Positive for peritoneal metastasis and grade ≥ 2 malignant ascites as confirmed by computed tomography (CT)\n3. PD-L1 combined positive score of ≥5 based on the 28-8 assay\n4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations\n5. Age \\> 19 years at time of study entry\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Life expectancy of \\> 4 months\n8. Body weight \\> 30kg\n9. No existing neuropathy\n10. Adequate normal organ and marrow function as defined below:\n\n    * Hemoglobin ≥9.0 g\u002FdL\n    * Absolute neutrophil count (ANC) 1.5 x (\\> 1500 per mm3)\n    * Platelet count ≥100 (or 75) x 109\u002FL (\\>75,000 per mm3)\n    * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)\n    * AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional ULN\n    * Measured creatinine clearance (CL) \\> 40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance:\n11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre- menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n\nExclusion Criteria:\n\n1. Disease progression within 6 months after completion of adjuvant chemotherapy.\n2. Participation in another clinical study with an investigational product during the last 2 weeks\n3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n4. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n5. Major surgical procedure within 28 days prior to the first dose\n6. Unable to take medication orally\n7. Gastrointestinal bleeding\n8. Impaired bowel absorption\n9. History of allogenic organ transplantation\n10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent\n11. History of another primary malignancy except for\n\n    * Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose and of low potential risk for recurrence\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    * Adequately treated carcinoma in situ without evidence of disease\n12. History of active primary immunodeficiency\n13. Active infectious disease\n14. Tuberculosis (based on clinical history, physical examination, radiographic findings, and TB testing in line with local practice)\n15. Hepatitis B (known positive HBV surface antigen (HBsAg) result)\n16. Hepatitis C (patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA)\n17. Human immunodeficiency virus (positive HIV 1\u002F2 antibodies)\n18. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible.\n19. Female patients who are pregnant or breastfeeding, as well as male or female patients of reproductive potential who are not willing to use effective contraception from the time of screening until 5 months following the final dose of lenvatinib.\n20. Known allergy or hypersensitivity to the investigational drug or any of its components.\n21. Patients with known deficiency of dihydropyrimidine dehydrogenase (DPD).\n22. Patients with known hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.","19 Years",{"count":143,"type":21},61,[24,65],"To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.",[147,93,40],"STOMACH NEOPLASM",[149,150,151,152],"Stomach Neoplasms","Gastric cancer","Lenvatinib","Advanced Gastric Cancer","2025-11-19",{"date":155,"type":46},"2025-11-20",{"date":157,"type":46},"2025-11-11",{"date":159,"type":21},"2027-07-30",{"name":161,"class":77},"Asan Medical Center",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100572231","phase-2-utidelone-capsule-monotherapy-for-patients-with-advanced-solid-tumors-100572231","NCT06730581","Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors","Phase II Clinical Trial of Utidelone Capsule in the Treatment of Advanced Solid Tumor Patients","Inclusion Criteria:\n\n\\-\n\n1、 For participants with advanced gastric cancer:Histologically and\u002For cytologically confirmed unresectable HER2-negative locally advanced or recurrent\u002Fmetastatic gastric or gastroesophageal junction adenocarcinoma (according to the 2019 WHO Classification of Digestive System Oncology).\n\n2、 For participants with advanced cholangiocarcinoma:Histologically and\u002For cytologically, patients were diagnosed with surgically unresectable advanced or metastatic cholangiocarcinoma.\n\n3、 For participants with advanced ovarian cancer:A histologically or pathologically confirmed diagnosis of high-grade serous ovarian cancer was consistent with platinum-resistant recurrent ovarian cancer (progression within 6 months after the last platinum-based chemotherapy) according to the 2020 WHO histopathological classification of ovarian tumors.\n\n4、 For participants with other tumors:\n\n1. Esophageal cancer: locally advanced recurrent or metastatic squamous esophageal cancer confirmed by histology or cytology.\n2. Hepatocellular carcinoma: clinically diagnosed or histologically\u002Fcytologically confirmed diagnosis of inoperable resectable or metastatic hepatocellular carcinoma (HCC) (according to the Guidelines for the Management of Primary Hepatocellular Carcinoma (2024 edition)); Child-Pugh score ≤ 7.\n3. Colorectal cancer: unresectable advanced\u002Fmetastatic colorectal cancer (mCRC) confirmed by histology or cytology.\n4. Recurrent or metastatic cervical cancer confirmed by histopathology, not amenable to radical surgical resection and\u002For radical radiotherapy, and pathologic type of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n\n5、For all participants:\n\n1. Subjects must give informed consent to the study prior to the study, and voluntarily sign a written informed consent form (ICF), understanding and agreeing to comply with the study requirements and test procedures;\n2. ≥18 years old and ≤70 years old;\n3. According to RECIST v1.1, patients had at least one target lesion (non-radiotherapy field) that could be measured by computed tomography (CT) or magnetic resonance imaging (MRI) (longest diameter ≥10mm, lymph node diameter ≥15mm, scan layer thickness ≤ 5mm).\n4. Have received at least one standard systemic therapy, and the number of previous systemic anti-tumor therapy lines is ≤4 (neoadjuvant and adjuvant chemotherapy regiments are not considered prior systemic therapy unless disease progression occurs during their chemotherapy or within 6 months after the last chemotherapy);\n5. The blood routine examination within 1 week before enrollment was basically normal (the normal value of the laboratory of each research center was the standard); No rhG-CSF, blood transfusion \u002FEPO and other drugs were used within 14 days before enrollment.\n\n   a. White blood cell count (WBC) ≥3.5 × 109\u002FL b.Neutrophil count (ANC) ≥ 1.5 × 109\u002FL; c.Platelet count (PLT) ≥ 100 × 109\u002FL; d.Hemoglobin ≥ 9.0 g\u002FdL.\n6. Within one week before enrollment, the blood biochemistry test was basically normal (based on the normal values of each research center laboratory):\n\n   a.Total bilirubin (TBIL) ≤ 1.5 x Upper limit of normal value (ULN) b.SGPT\u002FALT ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); c.SGOT\u002FAST ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); d.The creatinine clearance rate (Ccr) is ≥ 60 ml\u002Fmin (Cockcroft Gault formula).\n7. adequate coagulation function, defined as INR or PT ≤1.5 times ULN; If the subject was receiving anticoagulant therapy, as long as the PT was within the prescribed range of anticoagulant drugs.\n8. ECOG 0-1 with an expected survival of more than 12 weeks;\n9. Patients of childbearing potential had to consent to use a reliable contraceptive method (hormonal or barrier methods or abstinence) with their partner simultaneously during the trial and for at least 3 months after the last dose; Female patients of reproductive age had to have a negative blood or urine pregnancy test before enrollment.\n\nExclusion Criteria:\n\n\\-\n\n1、 For participants with advanced gastric cancer:Patients with HER2-positive disease.\n\n2、 For participants with advanced ovarian cancer: 1) Having a clear cell, mucinous or sarcomatous histology, containing mixed tumours of any histological type, or low grade\u002Fborderline ovarian cancer; 2) Platinum-refractory ovarian cancer: tumor progression assessed within 1 month after the last dose of platinum therapy.\n\n3、 For all participants:\n\n1. Other malignancies within 5 years, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid;\n2. Received nitrosourea or mitomycin C within 6 weeks prior to the first use of the study drug; Anti-tumor therapy, including chemotherapy, radiotherapy, biotargeted therapy, immunotherapy, etc. within 4 weeks or 5 half-lives (whichever is shorter) prior to the first use of the investigational drug; Oral fluorouracil, small molecule targeted drugs, or endocrine therapy within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug, whichever is shorter; Use of traditional Chinese medicine or proprietary Chinese medicine with anti-tumor indications within 2 weeks prior to the first use of the investigational drug.\n3. had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or required elective surgery during the trial period.\n4. Patients with peripheral neuropathy CTCAE 5.0 grade ≥2.\n5. The adverse reactions of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risk judged by investigators, such as alopecia).\n6. Patients who had previously used Utidelone injection.\n7. Patients with gastrointestinal bleeding, active gastrointestinal ulcers or gastrointestinal obstruction (including paralytic ileus), gastrointestinal perforation or fistula, and intraperitoneal abscesses within 6 months prior to the first use of the investigational drug;\n8. Patients with dysphagia, or other factors that affect the oral administration and absorption of drugs, or who require parenteral nutrition;\n9. Clinically active brain metastases, spinal cord compression, or spread of pia meningioma, defined as symptomatic or requiring steroid hormone or anticonvulsant therapy to control related symptoms; Patients with confirmed progression of brain metastases within 2 months after radiotherapy or other local treatment;\n10. Clinically severe lung injury caused by concurrent lung disease, including but not limited to any underlying lung disease (i.e., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc., with clinical symptoms requiring intervention within 3 months prior to the first use of the investigational drug);\n11. Patients with clinical symptoms of cancerous ascites, pleural effusion and pericardial effusion requiring puncture and drainage; Or had undergone drainage of ascites, pleural effusion, or pericardial effusion within 30 days prior to the first use of the study drug.\n12. Imaging shows that the tumor has invaded the vicinity of important blood vessels or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal massive bleeding;\n13. Have a history of severe cardiovascular and cerebrovascular disease, including but not limited to:\n\n    1. Have severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree Ⅱ-Ⅲ atrioventricular block, etc.; At rest, QTcF\\> 450 ms in men or 470ms in women was examined by 12-lead electrocardiogram (Fredericia's formula, see Appendix IV);\n    2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular event within 6 months prior to first use of the study drug;\n    3. Clinically uncontrollable hypertension;\n    4. Other researchers have identified a high risk of heart disease.\n14. Patients with uncontrolled diabetes within 3 months prior to first use of the study drug.\n15. Patients with active hepatitis B and\u002For hepatitis C, i.e. HBsAg positive and\u002For HBcAb positive with HBV DNA positive and\u002For anti-HCV positive and HCV RNA positive; Positive for human immunodeficiency virus (HIV) antibodies; The specific antibody of treponema pallidum was positive.\n16. Those who have an active infection and currently require systemic anti-infective therapy.\n17. Had an active autoimmune disease that required systemic treatment (i.e., disease modulators, corticosteroids, or immunosuppressive drugs) within 2 years prior to enrollment. Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a systemic treatment.\n18. Women who are pregnant or nursing or plan to become pregnant during the study period.\n19. Patients with mental disorders or poor compliance.\n20. Known allergy to the investigational drug or any of its excipients.\n21. Concurrent participation in another interventional clinical trial or use of another investigational treatment.\n22. The researchers believe that the subjects have a history of serious systemic disease, or other reasons should not be enrolled in this study.","70 Years",{"count":114,"type":21},[65],"This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors. The target population of the study is patients with advanced solid tumors (gastric cancer, ovarian cancer, cholangiocarcinoma and other tumors (esophageal cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer). The number of evaluable cases for tumor enrollment in gastric, ovarian, and bile duct cancers will be 20 cases each, and the total number of other tumors (including esophageal, liver, colorectal, and cervical cancers) will be no more than 40 cases. Patients who met the enrollment criteria received Utidelone capsule (UTD2) monotherapy.",[40,174,175],"Ovarian Cancer","Bile Duct Cancer",[93,174,177],"bile duct cancer","NOT_YET_RECRUITING","2024-12-08",{"date":181,"type":46},"2024-12-12",{"date":183,"type":21},"2024-12-01",{"date":185,"type":21},"2026-12-31",{"name":187,"class":53},"Beijing Biostar Pharmaceuticals Co., Ltd.",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":78},"100570763","phase-2-trifluridinetipiracil-tas-102-bevacizumab-and-camrelizumab-as-third-line-or-later-line-therapy-of-gastric-cancer-100570763","NCT06711471","Trifluridine\u002Ftipiracil (TAS-102), Bevacizumab, and Camrelizumab As Third-line or Later-line Therapy of Gastric Cancer","Phase II Study of Trifluridine\u002Ftipiracil (TAS-102), Bevacizumab, and Camrelizumab As a Third-line or Later-line Therapy for Patients with Metastatic Gastric Cancer","Inclusion Criteria:\n\n1. Patients with histopathological confirmed gastric\u002FGEJ adenocarcinoma.\n2. The clinical stage was IV, according to AJCC 8th edition.\n3. Patients had received at least two systematic therapies.\n4. Patients had received or not received immunotherapy.\n5. The patients received or did not receive anti-VEFGR targeted therapy in the last treatment (e.g., Bevacizumab, Ramucirumab, anti-VEGFR TKIs, etc.).\n6. Age ≥18.\n7. ECOG physical status score is 0-2 without deterioration within 2 weeks before the first administration of the investigational drug.\n8. Adequate organ function according to the following laboratory test values:\n\n   1. Hemoglobin value ≥90g\u002FL.\n   2. White blood cell count ≥3.5\\*109\u002FL.\n   3. Absolute neutrophil count ≥1.5\\*109\u002FL.\n   4. Platelet count ≥100\\*109\u002FL.\n   5. Serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance ≥60ml\u002Fmin.\n   6. Total serum bilirubin ≤1.5 upper normal limit (ULN).\n   7. Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤2.5 upper limit of normal value (ULN).\n9. With a full understanding of the study, each participant volunteered to participate in this study and signed the informed consent (ICF) with good compliance and follow-up.\n\nExclusion Criteria:\n\n1. Histopathological types other than adenocarcinoma include squamous cell carcinoma, adenosquamous carcinoma, neuroendocrine carcinoma, etc.\n2. Known hypersensitivity or previous treatment with trifluridine\u002Ftipiracil or any of its components or excipients.\n3. Known hypersensitivity to any component or excipients of bevacizumab.\n4. Requirement for systemic corticosteroids (\\>10mg\u002Fday of prednisone or equivalent other corticosteroids, for a continuous treatment of ≥7 days) or immunosuppressive therapy within 14 days before enrollment; excluding inhaled or topical steroid use, or hormone therapy for adrenal insufficiency at physiological replacement doses; short-term (≤7 days) corticosteroids are allowed for prevention (e.g., contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity caused by contact allergens).\n5. Receipt of a live vaccine (including attenuated live vaccines) or systemic immunostimulants (including but not limited to interferon or interleukin-2) within 28 days before enrollment.\n6. Past or current interstitial pneumonia disease, except for those non-active and not requiring hormone therapy determined by the investigator.\n7. Past or current autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophyseal inflammation, uveitis, autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. except for type I diabetes, hormonally replaced euthyroidism (including autoimmune thyroid disease causing hypothyroidism), psoriasis or vitiligo not requiring systemic treatment.\n8. History of hypersensitivity, severe allergic reactions, or intolerance to antibody medications; history of significant allergies to drugs, foods, or other substances (e.g., severe allergic reactions, immunologically mediated hepatotoxicity, immunologically mediated thrombocytopenia, or anemia).\n9. History of allogeneic bone marrow or organ transplantation.\n10. Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption.\n11. Recurrent bleeding that cannot be controlled (as judged by the investigator to be at risk for major gastrointestinal bleeding, etc.).\n12. Major surgery was performed within 4 weeks before the first study drug treatment (biopsy procedures excepted).\n13. Concurrent malignancy within the past 5 years, except for those adequately treated cervical carcinoma in situ, localized squamous cell carcinoma of the skin, basal cell carcinoma, asymptomatic prostate cancer, ductal carcinoma in situ of the breast, well-differentiated thyroid cancer, or urinary tract epithelial cancer \\\u003C T1, adequately treated lung carcinoma in situ, or other malignancies considered cured.\n14. History of gastrointestinal perforation and\u002For fistula within the past 6 months, history of intestinal obstruction (including incomplete obstruction requiring parenteral nutrition), inflammatory bowel disease, or extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n15. Any severe cardiac insufficiency, including left ventricular ejection fraction (LVEF) \\\u003C 50%, congestive heart failure (CHF) ≥ grade 2 (CTCAE v5.0 or New York Heart Association grade ≥ 2), myocardial infarction, severe\u002Funstable angina, stroke, or transient ischemic attack (TIA) within 6 months before enrollment.\n16. Uncontrolled hypertension (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg) and diabetes (fasting blood glucose \\> 8.9 mmol\u002Fl).\n17. History of ventricular tachycardia or torsades de pointes. Any resting ECG with significant clinical abnormalities in rhythm, conduction, or morphology, such as QTc \\> 450 msec for males, QTc \\> 470 msec for females, complete left bundle branch block, or third-degree atrioventricular block.\n18. Active hepatitis B (must meet both HBsAg positive and HBV DNA ≥ 2000 IU\u002Fml, or ≥ 104 copies, excluding hepatitis due to drugs or other causes), active hepatitis C (must meet both anti-HCV antibody positive and HCV RNA positive), syphilis (further testing for syphilis titer is required for those with positive syphilis antibodies), or human immunodeficiency virus (HIV) infection.\n19. Pulmonary embolism or deep vein thrombosis occurring within 3 months before the first administration of the study drug (excluding thrombosis caused by catheters such as port, PICC, etc.).\n20. Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or those who have received anti-tuberculosis treatment within 1 year before the first dose.\n21. Severe primary pulmonary disease, currently requiring continuous oxygen therapy for clinical active interstitial lung disease (ILD) or a history of pneumonia.\n22. Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infection requiring intravenous anti-infective treatment within 2 weeks before the first administration of the study drug.\n23. Known history of substance abuse or drug addiction.\n24. Pregnant or lactating women.\n25. Fertile but unwilling to use effective contraceptive measures.\n26. Any other diseases, metabolic disorders, or laboratory test abnormalities that the investigator has reason to suspect would make the patient unsuitable for treatment with the study drug, would affect the interpretation of the study results, or would place the patient at high risk.",{"count":196,"type":21},31,[65],"For patients with metastatic gastric cancer, the efficacy of current standard treatments outlined in the guidelines is far from meeting the clinical demand. This study aims to explore the efficacy and safety of trifluridine\u002Ftipiracil (TAS-102), bevacizumab plus camrelizumab as a novel third-line or later-line therapy for metastatic gastric cancer patients.",[40],"2024-11-27",{"date":202,"type":46},"2024-12-02",{"date":204,"type":46},"2024-11-14",{"date":206,"type":21},"2027-11-13",{"name":208,"class":77},"LIN YANG",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":218,"studyType":219,"phases":4,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":78},"100570087","the-correlation-between-blood-concentration-of-sintilimab-and-efficacy-and-adverse-reactions-in-patients-with-advanced-gastric-cancer-100570087","NCT06702683","The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer","Study on the Correlation Between Blood Concentration of Sintilimab and Related Predictors with Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer","Inclusion Criteria:\n\nA. Patients who were diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; B. Patients who plan to be treated with Sintilimab; C.ECOG score of 0-2; D. Expected survival ≥3 months; E. The patient who have good compliance, follow-up, and can cooperate with relevant treatment and examination; F. Agree to participate in the study and sign the informed consent\n\nExclusion Criteria:\n\nA. Patients who clinical information and data are incomplete; B. Patients who treated with immune checkpoint inhibitors within 6 months",{"count":217,"type":21},112,"3 Years","OBSERVATIONAL","Compared with other anti-tumor drugs, immune checkpoint inhibitors (ICIs) have their own unique pharmacokinetics (PK) and pharmacodynamics (PD), and affect patient clinical outcomes. However, at present, the data on the PK and PD characteristics of ICIs in the Chinese population are still lacking, thus further clinical trials are needed to verify them. At the same time, a large proportion of patients have no response to ICIs or the efficacy is poor, and even bring greater side effects, so it is particularly important to find effective biomarkers to predict the efficacy and adverse reactions of patients with ICIs treatment.The purpose of this study is to explore the correlation between blood concentration of Sintilimab and related predictors with efficacy and adverse reactions in patients with advanced gastric cancer so as to provide clinical reference for individualized treatment of patients with gastric cancer.",[222,223,224,40],"Gastric Carcinoma","Gastric Neoplasm","Gastric (cardia, Body) Cancer","2024-11-21",{"date":227,"type":46},"2024-11-25",{"date":229,"type":46},"2023-02-17",{"date":231,"type":21},"2025-12-31",{"name":233,"class":77},"Lin Liu"]