[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gej-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gej-adenocarcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,53,65,96,119,150,177,200],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100053828","phase-1-evaluation-of-xya02-in-patients-with-advanced-solid-tumors-100053828",false,"NCT07670312","Evaluation of XYA02 in Patients With Advanced Solid Tumors","A Phase 1b\u002F2, Multicenter, Non-randomized, Open-label, Multiple Dose First- In-Human Study of XYA02 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Signed informed consent form(s) (ICFs) obtained at Screening.\n2. Has an eligible relapsed\u002Frefractory tumor with measurable disease based on RECIST 1.1 at Screening.\n3. Age ≥18 years at Screening and confirmed at the discretion of the Investigator.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at Screening.\n5. Platelet (PLT) count ≥100,000\u002FmcL at Screening.\n6. Hemoglobin ≥9.5 g\u002FdL without packed red blood cells (RBCs) transfusion within 14 days prior to Screening.\n7. Absolute neutrophil count (ANC) ≥1,500\u002FmcL at Screening.\n8. Estimated creatinine clearance (CrCl) \\>60 mL\u002Fmin at Screening. Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤3 × the upper limit of normal (ULN) at Screening.\n\n10\\. Total bilirubin ≤1.5 × ULN at Screening; in patients with a documented history of Gilbert syndrome ≤3 × ULN.\n\n11\\. At least 28 days from treatment with monoclonal antibody-based therapies at Screening.\n\n12\\. At least 5 half-lives from treatment with chemotherapy and small molecule inhibitors at Screening. 13. At least 28 days from experimental therapies not covered above at Screening.\n\n14\\. At least 28 days from radiation to more than 30% of the bone marrow or a wide field of radiation at Screening. Radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study drug is acceptable. (In case of patients treated with radiotherapy, previously irradiated lesions should not be considered a target lesion on computed tomography \\[CT\\] unless evidence of regrowth\u002Fdisease progression has been documented.) 15. At least 28 days from major surgery or significant trauma with recovery of AEs to NCI-CTCAE Grade 1 or baseline at Screening.\n\n16\\. Availability of archival tissue or, if unavailable, will be willing to undergo a tumor biopsy if a low-risk biopsy procedure is feasible at Screening. 17. Has a life expectancy of ≥ 3 months at Screening.\n\nAdditional Inclusion Criteria for Phase 1 (Dose Escalation and Backfill):\n\n18\\. Has pathologically documented advanced, relapsed, or refractory NSCLC (non-squamous), ovarian (high grade serous), gastric\u002Fesophageal\u002FGEJ adenocarcinoma, or CRC at Screening. 19. Patient must have progressed on, have relapsed after, be refractory to, or be intolerant of at least 1 prior systemic therapy, without available subsequent standard of care and have no satisfactory alternative treatment options. No more than 4 prior lines of systemic therapy for advanced, relapsed, or refractory disease in NSCLC and ovarian and no more than 3 prior lines of systemic therapy in gastric\u002Fesophageal\u002FGEJ adenocarcinoma or CRC (excluding adjuvant chemotherapy).\n\nAdditional Inclusion Criteria for Phase 2 (Dose Expansion):\n\n20\\. Cohorts for 5 different prioritized tumor types and 1 basket cohort that are advanced\u002Funresectable or metastatic at Screening according to the following criteria:\n\n1. Cohort 2A: NSCLC non-squamous. Histologically confirmed locally advanced or metastatic NSCLC (non-squamous) that have relapsed after or are refractory to platinum-doublet based chemotherapy and\u002For immune checkpoint inhibitor (in combination or sequential). Patients with EGFR or anaplastic lymphoma kinase (ALK) mutations should have been treated with appropriate targeted therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy and\u002For immunotherapy).\n2. Cohort 2B: Ovarian. Histologically confirmed advanced or metastatic high-grade serous ovarian cancer that have relapsed after or are refractory to at least 1 prior line of chemotherapy and have no other satisfactory treatment options. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy or maintenance regimen).\n3. Cohort 2C: Gastric\u002Fesophageal\u002FGEJ adenocarcinoma. Histologically confirmed advanced or metastatic gastric, esophageal or GEJ adenocarcinoma that have relapsed after or are refractory to at least 1 prior line of therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n4. Cohort 2D: CRC. Histologically confirmed advanced or metastatic CRC that have relapsed after or are refractory to at least 1 prior line of therapy. BRAF mutated patients are excluded. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n5. Cohort 2E: Pancreatic cancer. Histologically confirmed locally advanced or metastatic pancreatic cancer that have relapsed after or are refractory to at least 1 prior systemic treatment regimen. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n6. Cohort 2F: Tumor agnostic. Histologically confirmed advanced or metastatic solid tumors other than ones in Cohorts 2A to 2E that have relapsed after treatment without available subsequent standard of care. The tumor indications in this group will be selected based on data from phase 1 and preclinical data.\n\nExclusion Criteria:\n\n1. Has been refractory (did not have a tumor response) to previous treatment with a topoisomerase 1 (TOP1) inhibitor antibody-drug conjugate, at the discretion of the investigator.\n2. Has a medical history of symptomatic congestive heart failure (CHF; New York Heart Association \\[NYHA\\] classes II-IV), prior documented left ventricular ejection fraction (LVEF) \\\u003C 50%, or serious cardiac arrhythmia requiring treatment at Screening and at the discretion of the Investigator.\n3. Has a clinically significant medical history of myocardial infarction or unstable angina within 6 months before Screening at the discretion of the Investigator.\n4. Has a QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 millisecond (ms) in males and \\> 470 ms in females based on a 12-lead electrocardiogram (ECG) in triplicate performed at Screening.\n5. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at Screening at the discretion of the Investigator.\n6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals at Screening at the discretion of the Investigator.\n7. Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at Screening. If known history of hepatitis, active hepatitis B infection is defined as hepatitis B surface antigen (HbsAg) positive or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive; and active hepatitis C infection is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) positive.\n8. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days before Screening.\n9. Male and female patients who are unwilling to use contraceptive methods at Screening (eg, concomitant use of a spermicidal agent and barrier contraceptive, intrauterine contraceptive during the study and for at least 7 months after the last dose of XYA02).\n10. Has clinically active brain metastases, defined as untreated and symptomatic, or requires therapy with steroids or anticonvulsants to control associated symptoms at Screening and at the discretion of the Investigator. Note: Patients with untreated asymptomatic brain metastases may be included in the study if they do not require radiotherapy treatment or surgical treatment, do not require treatment with steroids, and there are no untreated brain lesions \\> 20 mm in size.\n11. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, lymphopenia) not yet resolved to NCI-CTCAE Grade ≤ 1 or baseline at Screening. Patients with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator (eg, peripheral neuropathy, endocrinopathies).\n12. Has a concomitant medical condition that would increase the risk of toxicity at Screening.\n13. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product at Screening.\n14. Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer at Screening.","ALL","18 Years",{"count":19,"type":20},190,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study will evaluate the safety, tolerability, and efficacy of XYA02 in participants with advanced solid tumors.",[27,28,29,30,31,32],"MUC1-expressing Advanced, Relapsed and\u002For Refractory Solid Tumors","Non-Small Cell Lung Cancer","Ovarian Cancer","GEJ Adenocarcinoma","Colorectal Cancer","Pancreatic Adenocarcinoma",[34,35,28,36,37,38,39],"MUC-1","solid tumor","Ovarian","GEJ adenocarcinoma","Colorectal","Pancreatic","NOT_YET_RECRUITING","2026-07-09",{"date":43,"type":44},"2026-07-13","ACTUAL",{"date":46,"type":20},"2026-07-15",{"date":48,"type":20},"2030-07-15",{"name":50,"class":51},"XYone Therapeutics, Inc","INDUSTRY",5,{"id":54,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":25,"conditions":57,"keywords":58,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":64,"locationsCount":52},"100644475",{"count":19,"type":20},[23,24],[27,28,29,30,31,32],[34,35,28,36,37,38,39],"2026-06-25",{"date":61,"type":44},"2026-06-26",{"date":46,"type":20},{"date":48,"type":20},{"name":50,"class":51},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100627900","phase-1-ava6103-in-subjects-with-locally-advanced-or-metastatic-selected-solid-tumors-100627900","NCT07454642","AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","FOCUS-01","Inclusion Criteria:\n\n1. The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).\n2. Male or female subjects, ≥18 years of age.\n3. Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments\n\n   1. Cervical\u002Fvulvar cancer\n   2. SCLC\n   3. Gastric\u002FGEJ cancer\n   4. PDAC\n   5. CRC\n   6. HR+ breast cancer\n4. Has a life expectancy of ≥3 months, in the opinion of the investigator.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2).\n7. Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose):\n\n   1. Absolute neutrophil count of ≥1.5 × 109 cells\u002FL. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells\u002FL\n   2. Hemoglobin ≥9.0 g\u002FdL.\n   3. Platelet count of ≥100,000\u002FµL.\n   4. International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for subjects on direct acting anticoagulation.\n8. Has adequate liver function:\n\n   1. Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin \\\u003C3 × ULN).\n   2. AST and ALT ≤2.5 × ULN (in subjects with liver metastases, \\\u003C5 × ULN is allowed).\n9. Has adequate renal function as defined by creatinine clearance ≥ 60 mL\u002Fmin by the Cockcroft-Gault equation.\n10. Women of childbearing potential and women who have ≤2 years amenorrhea after start of menopause, must have a negative serum or urine pregnancy test within 7 days prior to Cycle 1 Day 1.\n11. Contraception requirements:\n\n    1. Female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C 1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    2. Male subjects with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    3. Male subjects must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n12. The subject is willing and able to comply with the protocol, including any PK blood sampling and tumor biopsy requirements and agrees to return to clinic for follow-up visits and examinations.\n\n    1. For subjects in Phase 1a or 1b, on treatment tumor biopsy is optional. -\n\nExclusion Criteria:\n\n1. Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg\u002Fday or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.\n2. Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.\n3. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n4. History or evidence of any other clinically unstable\u002Funcontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.\n5. History of known infection is defined as:\n\n   1. HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\>400 copies\u002FmL prior to study Day 1.\n   2. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n   3. Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Subjects with active disease who are not on\u002Fhave not initiated anti-retroviral treatment prior to study Day 1.\n   5. Subjects with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Subjects with treated HCV infection but with an HCV viral load above the level of quantification.\n   7. Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n6. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.\n7. Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.\n8. Is a pregnant or breastfeeding woman.\n9. Has a known hypersensitivity to any of the components of AVA6103 or any excipient of the product or to other topoisomerase 1 (TOP1) inhibitors.\n10. Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1.\n11. Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1, with the following exception:\n\n    1. Is planned for on-study treatment or has received within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1.\n    2. Subjects who have received a monoclonal antibody.\n12. Is currently taking St John's Wort, any drugs that are a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, CYP2D6, or P-glycoprotein (P-gp) such as ketoconazole, Nifedipine, erythromycin and fentanyl.\n13. Drugs which are strong inhibitors of multidrug resistance protein (MRP)2, MRP3 or MRP4.\n14. Is planned for on study treatment with any drugs that are sensitive CYP3A4 or organic anion transporting polypeptide (OATP)1B3 substrates, and\u002For where these drugs will be in the systemic circulation at the start of Cycle 1, Day 1. For this protocol, it means that the drug must not be used within 5 half-lives (or 5 days, whichever is longer) prior to AVA6103 Cycle 1 Day 1 and during study treatment.\n15. Has received granulocyte-colony stimulating factor (G-CSF), or red blood cell or platelet transfusion within 14 days prior to Cycle 1 Day 1.\n16. Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period.\n17. Has received live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: If a COVID-19 vaccine is administered it should be done \\>96 hours prior to AVA6103 administration. For the dose escalation phase, it should be administered after completion of the DLT period.\n18. QT interval corrected through use of Fridericia's formula (QTcF) \\> 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.",{"count":74,"type":20},174,[23],"This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[78,79,80,30,81,82,83,31,84],"Vulvar Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Gastric Adenocarcinoma","Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Small Cell Carcinoma of Lung","Hormone Receptor Positive Breast Carcinoma","RECRUITING","2026-05-29",{"date":88,"type":44},"2026-06-02",{"date":90,"type":44},"2026-03-31",{"date":92,"type":20},"2030-06",{"name":94,"class":51},"Avacta Life Sciences Ltd",3,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":4},"100630877","retlirafusp-alfa-injection-combined-chemotherapy-for-perioperative-treatment-of-esophagogastric-junction-adenocarcinoma-a-single-arm-phase-ii-study-of-safety-and-efficacy-100630877","NCT07493382","Retlirafusp Alfa Injection Combined Chemotherapy for Perioperative Treatment of Esophagogastric Junction Adenocarcinoma: A Single-Arm, Phase II Study of Safety and Efficacy","\\*\\*Inclusion Criteria:\\*\\*\n\n* Patients voluntarily enrolled in this study and signed informed consent forms;\n* Aged 18-75 years, no gender restrictions;\n* Histopathologically confirmed adenocarcinoma of the gastroesophageal junction with CPS \\> 5 and HER2-negative status;\n* Clinical stage T3-4aNxM0 gastroesophageal junction adenocarcinoma (AJCC\u002FUICC 8th Edition cTNM staging for esophageal\u002Fesophagogastric junction cancer); 5. Clinically determined resectable Siewert Type I or Siewert Type II locally advanced gastroesophageal junction adenocarcinoma;\n* At least one measurable lesion present, with spiraled CT scan feasible for efficacy assessment;\n* No prior anticancer therapy;\n* ECOG performance status: 0-1;\n* Adequate major organ function meeting the following criteria (no blood components or cell growth factors administered within 14 days prior to randomization):\n\n  1. Neutrophils ≥ 1.5 × 10⁹\u002FL; platelets ≥ 80 × 10⁹\u002FL; hemoglobin ≥ 9 g\u002FdL; serum albumin ≥ 3 g\u002FdL;\n  2. Total bilirubin ≤ 1.5 times upper limit of normal (biliary drainage permitted for biliary obstruction); ALT and AST ≤ 3 times upper limit of normal;\n  3. Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥ 50 mL\u002Fmin;\n  4. INR ≤ 1.5 times the upper limit of normal and APTT ≤ 1.5 times the upper limit of normal (patients on stable anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the therapeutic range may be included in screening); (5) Electrocardiogram: QTcF ≤ 450 milliseconds (males), ≤ 470 milliseconds (females);\n\n  (6) Cardiac ultrasound: Left ventricular ejection fraction (LVEF) ≥ 60%;\n* For patients with active hepatitis B virus (HBV) infection: HBV DNA must be \\\u003C500 IU\u002FmL (if the study site only has copy\u002FmL units, then \\\u003C2500 copies\u002FmL), and must have received at least 14 days of anti-HBV therapy (based on local standard treatment, e.g., entecavir) prior to study treatment initiation, with willingness to continue antiviral therapy throughout the study period; Patients with hepatitis C virus (HCV) RNA positivity must receive antiviral therapy according to local standard treatment guidelines, with liver function within the range of CTCAE Grade 1 elevation;\n* Women of childbearing potential must have a negative blood pregnancy test within 3 days prior to randomization and agree to use effective contraception during the trial and for 6 months after treatment completion. Men must be surgically sterilized or agree to use effective contraception during the study and for 3 months after treatment completion.\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Pregnant or lactating patients;\n* Patients who have received prior antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy;\n* Patients with other malignancies within the past 5 years (excluding basal cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer);\n* Uncontrolled pleural effusion, pericardial effusion, or ascites;\n* Clinically determined to be inoperable or with distant metastasis;\n* Severe cardiovascular disease within 12 months prior to enrollment, such as symptomatic coronary artery disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, myocardial infarction;\n* Concurrent upper gastrointestinal obstruction\u002Fbleeding, digestive dysfunction, or malabsorption syndrome;\n* History of gastrointestinal perforation within 6 months prior to enrollment;\n* Concurrent severe uncontrolled infections or other severe uncontrolled comorbidities, moderate or severe renal impairment;\n* Uncontrolled cardiac clinical symptoms or conditions, such as:\n\n  1. NYHA Class II or higher heart failure (see Appendix 5) or echocardiography showing LVEF \\\u003C50%;\n  2. Unstable angina;\n  3. Myocardial infarction within 1 year prior to study treatment initiation;\n  4. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \\> 450 ms (males); QTc \\> 470 ms (females) (QTc interval calculated using Fridericia's formula; if QTc is abnormal, measure three consecutive times at 2-minute intervals and take the average);\n* History of allergic reactions to drugs used in this study;\n* Use of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding intranasal, inhaled, or other locally administered corticosteroids, or physiologically dosed systemic corticosteroids (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent doses of other corticosteroids), or corticosteroids used for contrast medium allergy prophylaxis;\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Current interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring corticosteroid therapy, or other pulmonary conditions that may interfere with the assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on screening chest computed tomography (CT) or severe pulmonary impairment. Radiation pneumonitis in the radiation field is permitted. Active tuberculosis.\n* Active autoimmune disease or history of autoimmune disease with potential for recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects controllable only with hormone replacement therapy may be included\\]); Subjects with skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia), controlled type 1 diabetes managed with insulin, or childhood asthma in complete remission requiring no adult intervention may be included; asthma patients requiring bronchodilator medical intervention are excluded;\n* Use of immunosuppressive agents or systemic corticosteroids for immunosuppression within 14 days prior to study treatment initiation (dose \\> 10 mg\u002Fday prednisone or equivalent);\n* Severe infection within 4 weeks prior to study treatment initiation, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications; therapeutic antibiotic administration (oral or intravenous) within 2 weeks prior to study treatment initiation (patients receiving prophylactic antibiotics, e.g., for urinary tract infection prevention or chronic obstructive pulmonary disease exacerbation prevention, are eligible);\n* Patients with congenital or acquired immunodeficiency (e.g., HIV infection);\n* Use of immunosuppressive drugs within 4 weeks prior to first dose;\n* Administration of live attenuated vaccines within 4 weeks prior to first dose or planned administration of live attenuated vaccines during the study period;\n* Previous treatment with other anti-PD-1 antibodies or other PD-1\u002FPD-L1-targeted immunotherapies;\n* Palliative radiotherapy to non-target lesions for symptom control is permitted, provided it was completed at least 2 weeks prior to study treatment initiation and radiotherapy-related adverse events have not recovered to ≤CTCAE Grade 1;\n* Receipt of other investigational drug treatment within 28 days prior to study treatment initiation; The investigator determined that the patient has other factors that may affect study outcomes or necessitate premature termination of this study, such as alcohol abuse, substance misuse, other serious medical conditions (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or accompanying family or social factors that could compromise patient safety.","75 Years",{"count":104,"type":20},30,[106],"NA","This is a prospective, phase II, exploratory clinical trial. The study aims to evaluate the efficacy and safety of Retlirafusp alfa Injection in combination with chemotherapy during the perioperative period for the treatment of adenocarcinoma of the gastroesophageal junction.\n\nA perioperative regimen comprising 3 cycles of neoadjuvant therapy → surgery → postoperative stratified maintenance therapy was employed, specifically: Retlirafusp alfa Injection (30 mg\u002Fkg, intravenous injection, D1) combined with capecitabine (1000 mg\u002Fm², oral, twice daily, D1-14) + oxaliplatin (130 mg\u002Fm², IV, D1) every 3 weeks for 3 cycles, followed by surgery; Postoperatively stratified by Tumor Regression Grade (TRG): TRG 2-4 patients receive Retlirafusp alfa Injection maintenance therapy until disease progression or intolerance (maximum duration not exceeding 1 year); TRG 1\u002F5 patients undergo postoperative observation only.",[30],"2026-03-20",{"date":111,"type":44},"2026-03-25",{"date":113,"type":20},"2026-04-01",{"date":115,"type":20},"2029-04-01",{"name":117,"class":118},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":138,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100606945","phase-1-a-phase-1-study-of-nrm-823-in-participants-with-locally-advanced-or-metastatic-refractory-solid-tumors-100606945","NCT07182149","A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","A Phase 1a\u002F1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","Inclusion Criteria:\n\n* Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric\u002FGEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate liver, renal, pulmonary, and cardiac function.\n* Adequate hematologic function.\n\nExclusion Criteria:\n\n* Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823\n* History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy.\n* Has received an investigational therapy \\\u003C4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823.\n* With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.",{"count":127,"type":20},150,[23],"This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.",[131,132,133,80,30,29,134,135,136,137],"HNSCC","ESCC","Esophageal Adenocarcinoma","NSCLC","Cervical Cancer","Endometrial Cancer","Triple Negative Breast Cancer (TNBC)",[139],"NRM-823","2026-02-10",{"date":142,"type":44},"2026-02-12",{"date":144,"type":44},"2025-10-30",{"date":146,"type":20},"2028-10-31",{"name":148,"class":51},"Normunity AccelCo, Inc.",9,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":176},"100618654","phase-1-fruquintinib-combined-with-trastuzumab-and-xelox-as-first-line-treatment-in-patients-with-her2-positive-advanced-gastric-cancer-100618654","NCT07334431","Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer","Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: an Open-label, Single-arm, Single-center Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* Have fully understood the study and voluntarily signed the informed consent;\n* 18-75 years old (including 18 and 75 years old);\n* Pathologically determined advanced gastric or gastroesophageal junction adenocarcinoma;\n* No previous anti-tumor treatment for metastatic diseases;\n* HER2 positive;\n* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;\n* Life expectancy ≥ 3 months;\n* At least one measurable lesion according to RECIST version 1.1;\n* The functions of vital organs met the following requirements (Blood components and cell growth factors were not allowed within 14 days before enrollment):\n\n  * Absolute neutrophil count ≥1.5×109\u002FL;\n  * Platelet ≥100×109 \u002FL;\n  * Hemoglobin ≥90g\u002FL;\n  * Total bilirubin \\\u003C 1.5 ULN;\n  * ALT and\u002For AST \\\u003C 1.5 ULN ;\n  * Serum creatinine (Cr) \\\u003C1.5×ULN;\n  * Endogenous creatinine clearance ≥50ml\u002Fmin;\n* Female patients of childbearing age should take effective contraceptive measures;\n* Good compliance, cooperate with follow-up.\n\nExclusion Criteria:\n\n* Failure to comply with the study protocol or study procedure;\n* Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors, chemotherapy or immune checkpoint inhibitors;\n* Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;\n* Known presence of symptomatic central nervous system metastasis or brain metastases;\n* Had autoimmune disease or history of autoimmune disease within 4 weeks before enrollment;\n* Previously received allogeneic bone marrow transplantation or organ transplantation;\n* Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as determined by the researcher);\n* Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurs within 6 months before the start of study treatment;\n* Subjects who are allergic to the investigational drug or any of its adjuncts;\n* Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;\n* International Standardized Ratio (INR) \\>1.5 or partially activated prothrombin time (APTT) \\>1.5×ULN;\n* The investigator identified clinically significant electrolyte abnormalities;\n* Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n* Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration ≥CTCAE level 2 after formal treatment);\n* Had any disease or condition prior to enrollment that affected drug absorption, or the patient could not take fruquintinib orally;\n* Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectosed tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;\n* Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \\>30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks \\>5 mL of fresh blood) or had a thromboembolic event (including stroke events and\u002For transient ischemic attacks) within 12 months;\n* Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \\>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \\\u003C50%;\n* Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \\>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \\>50%;\n* Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity;\n* Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n* Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment;\n* Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk；\n* Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume \\> 1.0g;\n* Complications require long-term treatment with immunosuppressants or systemic or local use of immunosuppressive corticosteroids (\\> 10mg\u002F day prednisone or other therapeutic hormone);\n* Investigators believe that the patient has any other conditions that are not suitable for participating in the study.",{"count":158,"type":20},45,[23,24],"This study was designed to evaluate the safety and efficacy of fruquintinib plus trastuzumab, and XELOX as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.",[80,162,30,163,164,165],"Gastric (Stomach) Cancer","HER2-positive Gastric Cancer","First-line Therapy","Fruquintinib","2025-12-30",{"date":168,"type":44},"2026-01-12",{"date":170,"type":44},"2024-02-22",{"date":172,"type":20},"2026-12-31",{"name":174,"class":175},"Henan Cancer Hospital","OTHER_GOV",1,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":176},"100584338","phase-2-fruquintinib-combined-with-pd-1-inhibitor-as-first-line-maintenance-therapy-for-advanced-gastric-cancer-100584338","NCT06888037","Fruquintinib Combined With PD-1 Inhibitor as First-line Maintenance Therapy for Advanced Gastric Cancer","A Prospective, Multicenter Clinical Study of Fruquintinib Combined With PD-1 Monoclonal Antibody as First-line Maintenance Therapy in Patients With HER-2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Voluntarily signed the informed consent and had good compliance;\n* Age ≥18 years, Eastern Cooperative Oncology Group (ECOG) score 0-1, and expected survival time ≥12 months;\n* Histologically or cytologically unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;\n* He had not received previous systemic chemotherapy for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma;\n* Patients with disease progression\u002Frelapse occurring more than 6 months after completion of neoadjuvant\u002Fadjuvant therapy;\n* At least one measurable lesion according to RECIST version 1.1;\n* Tumor tissue\u002Fserum samples were tested as microsatellite stable (MSS) or mismatch repair intact (pMMR), HER2 negative;\n* Adequate organ functions:\n\nAbsolute neutrophil count ≥1.5×109\u002FL; Platelet ≥100×109\u002FL; Hemoglobin ≥90g\u002FL; WBC≥3×109\u002FL Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN (If liver metastasis, AST and ALT≤5 XULN)； Serum creatinine (Cr) ≤1.5XULN or serum creatinine clearance ≥50 ml\u002Fmin； Urinary protein ≤2+, or 24-hour urinary protein volume ≤2000mg; Prothrombin time (PT) and partially activated prothrombin time (APTT) ≤1.5×ULN;\n\n• Female or male patients of reproductive age must use effective contraception throughout and for 6 months after treatment.\n\nExclusion Criteria:\n\n* Participated in other drug clinical trials within 4 weeks before enrollment;\n* Have had other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, papillary carcinoma of the thyroid, superficial bladder, carcinoma in situ of the breast, and carcinoma in situ of the cervix ;\n* History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ grade 2 (NCI-CTCAE 5.0), heart failure ≥ grade 2 New York Heart Association (NYHA), transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, etc.\n* Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) and type 2 diabetes uncontrolled by antidiabetic treatment (fasting blood glucose ≥8.9mmol\u002FL);\n* Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis;\n* Type 1 diabetes mellitus, hypothyroidism that can be controlled only with replacement therapy, and skin diseases (e.g., vitiligo, psoriasis) that do not require systemic treatment could be included;\n* Central nervous system (CNS) metastases that are not adequately treated, or the presence of uncontrolled or symptomatic active CNS metastases; Patients with adequately treated CNS metastases and neurologic symptoms that had returned to baseline at least 4 weeks before enrollment (with the exception of residual signs or symptoms related to CNS therapy) were eligible for enrollment; In addition, participants had to discontinue corticosteroids or to be taking a stable or tapering dose of prednisone (or equivalent doses of other corticosteroids) of 10 mg or less per day at least 4 weeks before enrollment;\n* The patients had pleural effusion and ascites that could not be controlled by puncture drainage and other treatments within 14 days before enrollment. Moderate or greater pericardial effusion with clinical symptoms;\n* A live or attenuated live vaccine was administered within 30 days before enrollment;\n* Major surgery had been performed within 28 days before enrollment or minor nonstudy-related surgery had been performed within 7 days before enrollment (with the exception of tumor biopsy and venous-access port placement);\n* Patients with clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment; Patients with gastrointestinal perforation and\u002For gastrointestinal fistula within 6 months before enrollment (except those whose symptoms disappeared after gastric cancer resection for bleeding\u002Fperforation of gastric cancer);\n* Arterial\u002Fvenous thrombotic events, such as cerebrovascular accident (including transient ischemic attack, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months beforeenrollment;\n* Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral thrombosis) within 6 months before enrollment;\n* Severe, unhealed or open wounds and active ulcers or untreated fractures;\n* Had a history of immediate anaphylaxis;\n* The presence of clinically significant pulmonary fibrosis or interstitial pneumonia as judged by the investigator; Had active lung infection prior to injection and required anti-infective therapy;\n* Active infections included tuberculosis (medical history, investigator's judgment, radiological examination, and local laboratory testing), hepatitis B (hepatitis B surface antigen positive and HBV DNA above the upper limit of the study center's normal range), hepatitis C (HCV antibody positive and HVC RNA positive), HIV (HIV antibody positive), syphilis, etc;\n* Had active gastrointestinal bleeding or hemoptysis;\n* A history of alcohol or psychotropic substance abuse with no withdrawal or a history of mental disorder;\n* Known allergy to the study drug or any of its excipients; Or severe allergic reactions to other monoclonal antibodies;\n* Systemic antibiotic use for ≥ 7 days within 4 weeks before enrollment or unexplained fever \\>38.5°C during screening or before the first dose (fever due to a neoplastic cause, as judged by the investigator, was eligible);\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Unable to take oral medication;\n* The presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation in the study.",{"count":185,"type":20},55,[24],"This study was designed to explore the efficacy and safety of fruquintinib combined with PD-1 inhibitors as first-line maintenance therapy for advanced HER-2 Negative Gastric Cancer.",[80,30,164,189,165,190],"Maintenance Therapy","PD-1","2025-03-20",{"date":193,"type":44},"2025-03-21",{"date":195,"type":20},"2025-03-31",{"date":197,"type":20},"2028-12-31",{"name":199,"class":118},"Ruijin Hospital",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":220,"locationsCount":176},"100583069","phase-1-fruquintinib-combined-with-pd-1-inhibitor-and-folfox-as-first-line-treatment-for-advanced-gastric-cancer-100583069","NCT06871527","Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer","Fruquintinib Combined With Tislelizumab and FOLFOX as First-Line Treatment For Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Open-label, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* 18-75 years old (including 18 and 75 years old);\n* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;\n* Pathologically determined gastric or gastroesophageal junction adenocarcinoma;\n* Advanced patients with radiographic confirmation of inoperable complete resection;\n* No previous anti-tumor treatment for metastatic diseases;\n* At least one measurable lesion according to RECIST version 1.1;\n* Ability to take medications orally;\n* No active bleeding;\n* Adequate organ functions:\n\nAbsolute neutrophil count ≥2×109\u002FL; Platelet ≥100×109\u002FL; Hemoglobin ≥90g\u002FL; WBC≥4×109\u002FL Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN ； Serum creatinine (Cr) ≤1.5XULN；\n\n• Have fully understood the study and voluntarily signed the informed consent;\n\nExclusion Criteria:\n\n* Patients who had received any drug in the study protocol in the last year;\n* Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;\n* HER2 positive（HER-2 3+, or HER-2 2+ and FISH+）;\n* Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n* Patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment;\n* Patients with massive pleural or peritoneal effusion requiring drainage;\n* Patients with severe ECG abnormalities or heart diseases (such as cardiac insufficiency, myocardial infarction, angina pectoris) that affect clinical treatment;\n* Severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n* Mental disorders or central nervous system diseases or brain metastases affecting clinical treatment;\n* Patients with autoimmune diseases;\n* Patients with grade 3 or higher bleeding within 4 weeks;\n* Patients with a history of allergy to any drug, similar drug or vehicle in this study;\n* Had a major surgical procedure (thoracotomy, or laparotomy , etc.) within 4 weeks prior to the first dose of study therapy;\n* Patients with nonhealed wounds, ulcers, or fractures;\n* Patients who required systemic corticosteroids (excluding temporary testing, prophylactic administration for anaphylaxis), or immunosuppressive agents or had received such agents within 14 days before enrollment;\n* Pregnant or lactating women, or patients of childbearing age who refused contraception during the study period;\n* Investigators believe that the patient has any other conditions that are not suitable for participating in the study.",{"count":208,"type":20},44,[23,24],"This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.",[162,80,165,212,213,30],"PD-1 Inhibitor","Tislelizumab","2025-03-11",{"date":216,"type":44},"2025-03-12",{"date":218,"type":20},"2025-03-01",{"date":197,"type":20},{"name":221,"class":118},"Sixth Affiliated Hospital, Sun Yat-sen University"]