[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-or-gastroesophageal-junction-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-or-gastroesophageal-junction-adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,65,88,117,139,163,187,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100639966","phase-1-neoadjuvant-shr-a1811-and-shr-a1701-for-potentially-immunotherapy-sensitive-gc-or-gej-adenocarcinoma-100639966",false,"NCT07581574","Neoadjuvant SHR-A1811 and SHR-A1701 for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma","Trastuzumab Rezetecan Antibody-Drug Conjugate Combined With Retlirafusp α in Patients With HER2-Positive and Potentially Immunotherapy-Sensitive Gastric or Gastroesophageal Junction Adenocarcinoma,a Prospective Phase Ib Trial","Inclusion Criteria:\n\n* Voluntary Participation: The subject voluntarily agrees to participate in this study, is able to sign the informed consent form (ICF), and has good compliance.\n* Age and Gender: Aged 18 to 75 years (at the time of signing the ICF), regardless of gender.\n* Diagnosis and Staging: Histologically and\u002For cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma. Diagnosed as locally advanced according to the AJCC 8th Edition criteria, with cTNM staged as T3-4N+M0 based on endoscopic ultrasound or contrast-enhanced CT\u002FMRI scans (combined with diagnostic laparoscopy if necessary). The subject must agree to undergo radical surgery, and the investigator assesses the lesion as potentially resectable.\n* Treatment History: No prior systemic therapy for the current disease, including anti-tumor radiotherapy, chemotherapy, or immunotherapy.\n* HER2 Status: Confirmed HER2 IHC 3+ or HER2 IHC 2+ with positive FISH result based on endoscopic biopsy tissue IHC results.\n* Biomarker Status: PD-L1 CPS ≥1, EBV-positive, or dMMR\u002FMSI-H; at least one of the three criteria must be met.\n* Performance Status: ECOG score of 0-1.\n* Life Expectancy: Estimated life expectancy ≥6 months.\n* Organ Function: Adequate major organ function\n* Contraception and Pregnancy: Subjects of childbearing potential must use appropriate contraception methods during the study and for 120 days after the end of the study. Serum pregnancy test must be negative within 7 days prior to study enrollment, and the subject must not be breastfeeding.\n\nExclusion Criteria:\n\n* Other Malignancies: Concomitant malignant diseases other than gastric cancer (excluding early-stage tumors that have been radically cured).\n* Bleeding Risk: Tumor lesions with a tendency to bleed (e.g., active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months prior to signing the ICF, or judged by the investigator to be at risk of massive gastrointestinal bleeding) or have received blood transfusion therapy within 4 weeks prior to the administration of the study drug.\n* Concurrent Studies: Currently participating in other interventional drug clinical studies, or have received other investigational drugs or investigational device therapy within 4 weeks prior to the first dose.\n* Prior Therapies: Previous exposure to the following therapies: anti-HER2, anti-PD-1, anti-PD-L1 agents, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).\n* Autoimmune Disease: Active autoimmune disease that required systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose.\n\nNote: The use of physiological doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment.\n\n* Prior Medication: Received systemic treatment with Traditional Chinese Medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukins, excluding local use for pleural effusion control) within 2 weeks prior to the first dose.\n* Transplant History: Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n* Allergy: Known hypersensitivity to the drugs used in this study.\n* Neuropathy: Peripheral neuropathy ≥ Grade 2.\n* HIV Infection: Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive).\n* Hepatitis: Subjects with active Hepatitis B or Hepatitis C.\n* Vaccination: Received live vaccines within 30 days prior to the first dose (Cycle 1, Day 1).\n\nNote: Inactivated virus vaccines for seasonal influenza (injection) are permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted.\n\n* Pregnancy\u002FLactation: Pregnant or breastfeeding women.\n* Uncontrolled Systemic Disease: Presence of any severe or uncontrolled systemic disease.\n* Patients with mental disorders who are unable to cooperate with treatment;\n* Other: Any history or evidence of disease, treatment, or abnormal laboratory values that may interfere with trial results or hinder the subject's full participation in the study, or other conditions deemed by the investigator to pose potential risks or make the subject unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a prospective, single-center, single-arm, phase Ib clinical study. It plans to enroll eligible patients with locally advanced gastric\u002Fgastroesophageal junction adenocarcinoma who are HER2-positive and have potential benefit from immunotherapy (PD-L1 CPS≥1, EBV-positive, or dMMR\u002FMSI-H). These patients will receive four cycles of neoadjuvant therapy with Trastuzumab Rezatecan plus Rilafup alfa, followed by radical surgery.\n\nAll subjects will receive the same investigational treatment regimen, with no parallel control group. All enrolled subjects will receive the neoadjuvant treatment regimen of Trastuzumab Rezatecan combined with Retlirafusp alfa. The specific interventions are as follows:\n\n5.1.1 Neoadjuvant Drug Information and Dosing Regimen Trastuzumab Rezatecan Supplier: Jiangsu Hengrui Medicine Co., Ltd. Dosage: 4.8 mg\u002Fkg, intravenous infusion Frequency: Once every 3 weeks (Q3W) Retlirafusp alfa (SHR-1701) Supplier: Jiangsu Hengrui Medicine Co., Ltd. Dosage: 30 mg\u002Fkg, intravenous infusion Frequency: Once every 3 weeks (Q3W) The neoadjuvant treatment phase will consist of 4 cycles, with each cycle lasting 21 days, for a total treatment duration of approximately 12 weeks. Imaging examinations will be performed after 2 cycles.\n\n5.1.2 Preoperative Assessment and Surgery Within 4 weeks after the completion of neoadjuvant therapy, patients will undergo imaging examinations for surgical feasibility assessment. Those eligible for surgery will undergo radical gastrectomy (D2 lymphadenectomy) 4-6 weeks after the last dose.\n\nThe primary endpoint is safety and tolerability, specifically including:\n\nPrimary Endpoint:\n\nSafety and Tolerability: including the incidence, type, and severity of dose-limiting toxicities (DLTs); the incidence and treatment-relatedness of adverse events (AEs) and serious adverse events (SAEs); and the determination of the recommended phase II dose (RP2D).\n\nSecondary Endpoints:\n\npCR rate (the percentage of subjects achieving pathological complete response, defined as the absence of residual viable tumor cells in the primary tumor bed); MPR rate (the percentage of subjects achieving major pathological response, defined as ≤10% residual viable tumor cells in the tumor bed); EFS (Event-Free Survival, defined as the time from the initiation of treatment to the first occurrence of any of the following events: disease progression precluding surgical resection, local or distant recurrence, or death from any cause); R0 resection rate (defined as macroscopically tumor-free surgical margins and microscopically negative tumor cells within 1 mm of the surgical margin); OS (Overall Survival, defined as the time from the start date of neoadjuvant therapy to death from any cause or the date of the last follow-up).\n\nExploratory Endpoints:\n\nInfiltration status of immune cell subsets in tumor tissue before and after treatment.",[27],"Gastric or Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-05-14",{"date":31,"type":32},"2026-05-18","ACTUAL",{"date":34,"type":21},"2026-05-01",{"date":36,"type":21},"2029-05-31",{"name":38,"class":39},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100624359","phase-2-perioperative-chemotherapy-with-low-dose-radiotherapy-and-tislelizumab-for-locally-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100624359","NCT07408609","Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase II Multicenter Randomized Controlled Trial of Perioperative Chemotherapy Combined With Low-Dose Radiotherapy and Tislelizumab Versus Chemotherapy Alone in Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1.Voluntary participation with written informed consent obtained; 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert type II\u002FIII) by endoscopic biopsy (pathology from outside institutions must be reviewed by the study center); 3. Staged as cT1-2N1-3M0 or cT3-4aN0-3M0 according to the AJCC 8th edition, based on endoscopy and imaging (CT, MRI, or PET-CT); 4. Age ≥20 and ≤80 years, male or female; ECOG performance status of 0-1; 5. Presence of measurable and\u002For non-measurable disease per RECIST v1.1; 6.No prior systemic antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational agents; Adequate organ function (no blood products or growth factors within 2 weeks prior to screening); 7. Women of childbearing potential must have a negative pregnancy test within 72 hours prior to first dosing and agree to use effective contraception during the study and for 5 months after the last dose; men with partners of childbearing potential must use effective contraception during the study and for 7 months after the last dose.\n\nExclusion Criteria:\n\n1. History of surgery for gastric or gastroesophageal junction tumors;\n2. Prior history of fistula formation caused by invasion of the primary tumor; 3.High risk of gastrointestinal bleeding or perforation;\n\n4.Poor nutritional status, defined as BMI \\\u003C18.5 kg\u002Fm² or PG-SGA score ≥9; 5. Major surgery or severe trauma within 4 weeks prior to first study drug administration; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Prior or ongoing treatment with anti-PD-1\u002FPD-L1 antibodies, chemotherapy, radiotherapy, or targeted therapy; 7. Use of any investigational drug within 4 weeks prior to first study drug administration; Requirement for systemic corticosteroids; 8. Prior receipt of antitumor vaccines or live vaccines within 4 weeks before first study drug administration; 9. Active autoimmune disease or history of autoimmune disease; 10.History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, solid organ transplantation, or allogeneic bone marrow transplantation; 11.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 12.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 13.Severe infection (CTCAE grade \\>2) within 4 weeks prior to treatment, including infections requiring hospitalization; evidence of active pulmonary infection at baseline imaging or infections requiring antibiotics within 2 weeks prior to enrollment (prophylactic antibiotics excluded); 14.History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 15.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 16.Active hepatitis B (HBV DNA ≥2,000 IU\u002FmL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 17.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 18.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 19.Severe infection (CTCAE grade \\>2) within 4 weeks prior to treatment; History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 20.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 21.Active hepatitis B (HBV DNA ≥2,000 IU\u002FmL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 22.Grade \\>1 abnormalities in serum sodium, potassium, or calcium within 2 weeks prior to enrollment that cannot be corrected with treatment.","20 Years","80 Years",{"count":51,"type":21},114,[53],"PHASE2","This study is a prospective, multicenter, randomized, phase II clinical trial enrolling patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study aims to compare the efficacy and safety of perioperative chemotherapy combined with low-dose radiotherapy and tislelizumab versus perioperative chemotherapy alone in this patient population.",[27],"2026-02-12",{"date":58,"type":32},"2026-02-13",{"date":60,"type":21},"2026-02-26",{"date":62,"type":21},"2031-02-20",{"name":64,"class":39},"Jiangsu Cancer Institute & Hospital",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100623721","phase-2-first-line-treatment-of-gastric-or-gastroesophageal-junction-adenocarcinoma-with-dual-immunotherapy-combined-with-chemotherapy-100623721","NCT07400315","First-line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Dual Immunotherapy Combined With Chemotherapy","A Prospective, Single-arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Modified FLOT Regimen (TFOX) as First-line Treatment for HER2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* 1\\. The participant voluntarily agrees to participate in this study, signs the informed consent form, and strictly adheres to the requirements of the study protocol.\n* 2\\. Age ≥18 years and ≤75 years at enrollment, regardless of gender.\n* 3\\. Histologically confirmed unresectable locally advanced or metastatic G\u002FGEJ adenocarcinoma, with inclusion criteria specifying HER2- status (HER2+ status defined as IHC3+ or IHC2+ and FISH+).\n* 4\\. No prior systemic treatment for unresectable locally advanced or metastatic G\u002FGEJ adenocarcinoma; previous neoadjuvant and\u002For adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 12 months prior to the diagnosis of unresectable or metastatic disease.\n* 5\\. At least one measurable tumor lesion according to RECIST 1.1 criteria.\n* 6\\. ECOG PS of 0 or 1.\n* 7\\. Life expectancy ≥3 months.\n* 8\\. Fully recovered from any toxicities related to prior treatments prior to enrollment in the study.\n* 9\\. BMI \\>18.\n* 10\\. Adequate function of major organs\n* 11\\. Fertile subjects must use appropriate contraception during the study and for 120 days after the end of the study. They must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breastfeeding.\n\nExclusion Criteria:\n\n* 1\\. Any unstable systemic disease: including active infection, uncontrolled hypertension, unstable angina, angina that started within the last 3 months, congestive heart failure (New York Heart Association \\[NYHA\\] ≥Class II), myocardial infarction within 6 months prior to enrollment, severe arrhythmias requiring medication, or hepatic, renal, or metabolic diseases.\n* 2\\. Symptomatic brain and\u002For leptomeningeal metastases.\n* 3\\. Known deficiency of dihydropyrimidine dehydrogenase (DPD).\n* 4\\. QT\u002FQTc interval \\>450 ms for males, \\>470 ms for females.\n* 5\\. History of other malignancies within 5 years prior to enrollment, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.\n* 6\\. History of organ transplantation or autologous\u002Fallogeneic stem cell transplantation.\n* 7\\. Currently receiving systemic immunotherapy or hormone therapy other than physiologic replacement therapy.\n* 8\\. Other concurrent anti-tumor treatments.\n* 9\\. Known hypersensitivity or allergic reaction to any component of the study treatment.\n* 10\\. Previous exposure to docetaxel or oxaliplatin (except for adjuvant chemotherapy).\n* 11\\. Previous exposure to immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40), or any immunotherapy targeting tumor immune mechanisms.\n* 12\\. Participants with severe bone marrow failure.\n* 13\\. Any disease, metabolic disorder, or physical examination or laboratory findings that suggest contraindications to the study drug or high-risk factors for treatment complications.\n* 14\\. Known or self-reported human immunodeficiency virus (HIV) infection.\n* 15\\. Participants who are HBV or HCV positive.\n* 16\\. Pregnant or breastfeeding.\n* 17\\. Received a live vaccine within 4 weeks prior to the first dose, or plans to receive a live vaccine during the study.\n* 18\\. Participated in any investigational drug treatment or used any investigational device within 4 weeks prior to the first dose.\n* 19\\. Any condition that the investigator believes may pose a risk to the participant receiving the study drug, or may interfere with the evaluation of the study drug, the safety of the participant, or the interpretation of the study results.",{"count":73,"type":21},64,[53],"A prospective, single-arm, multicenter, Phase II clinical study of Apatolimab Tovolimab (QL1706) in combination with modified FLOT regimen (TFOX) as first-line treatment for HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma",[27],[27,78,79],"Iparomlimab and Tuvonralimab Injection","TFOX","2026-02-03",{"date":82,"type":32},"2026-02-10",{"date":84,"type":21},"2026-03-01",{"date":86,"type":21},"2029-03-31",{"name":38,"class":39},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100580774","phase-2-utidelone-capsule-combined-with-fluoropyrimidine--and-platinum-containing-therapy-in-first-line-treatment-of-patients-with-gastric-or-gastroesophageal-junction-adenocarcinoma-100580774","NCT06841679","Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma","A Multi-national, Open-label, Randomized Phase II\u002FIII Clinical Study of Utidelone Capsule (UTD2) Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Participants must meet the following criteria to be eligible for the study:\n\n  1. Sign the informed consent form (ICF) to participate with accordance with GCP, ICH and local regulations and are willing to adhere to the study protocol.\n  2. Male and female aged ≥ 18 years as of the date of baseline visit.\n  3. Participant must have unresectable locally advanced or metastatic GC or GEJ and have histologically\u002Fpathologic confirmed predominant adenocarcinoma. The documentation of GEJ involvement can include biopsy, endoscopy, or imaging.\n  4. Phase II Study: No restriction on PD-L1 expression. Phase III study: Participant must have tumor with PD-L1 Combined Positive Score (CPS) \\\u003C 1 by immunohistochemical (IHC). IHC results from site are acceptable.\n  5. Participant must have at least one measurable lesion per RECIST 1.1 criteria.\n  6. Participant must not receive previously systemic treatment in the advanced setting. Previously neoadjuvant\u002Fadjuvant therapy for GC or GEJ with no progression after 6 months from completion is allowed. Palliative radiotherapy is allowed.\n  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n  8. Participant with adequate hematological function (CTCAE v5.0 Grade ≤ 1) within 1 week before enrollment (based on routine laboratory values at each site) and who have not received recombinant human granulocyte colony-stimulating factor (rhG-CSF) or blood products\u002Ferythropoietin (EPO) within 14 days before enrollment.\n\n     * White blood cell count (WBC) ≥ 3.0 × 109\u002FL;\n     * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL;\n     * Platelet count (PLT) ≥ 100 × 109\u002FL;\n     * Hemoglobin (Hb) ≥ 9.0 g\u002FdL.\n  9. Participant with adequate liver and renal function (CTCAE v5.0 Grade ≤ 1) within 1 week before enrollment (based on routine laboratory values at each site).\n\n     * Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN);\n     * Alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatic metastases);\n     * Aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatic metastases);\n     * Creatinine clearance (Ccr) ≥ 50 mL\u002Fmin.\n  10. Female Participants of childbearing potential must agree to use highly effective contraceptive methods during the study and within 6 months after the last dose of the investigational product. Female patients of childbearing potential shall have a negative serum or urine pregnancy test at screening and be willing to have additional pregnancy tests as required throughout the study. Women of non-childbearing potential (WONCBP) must not donate ova from signing informed consent until at least 6 months after the last administration of the investigational product. Please refer to Appendix 1. Males must be surgically sterile (\\> 6 months since vasectomy with confirmation of no viable sperm), or if engaged in sexual relations (intercourse) with a WOCBP, either his partner must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method must be used from Screening until 6 months after last IMP administration; or Males with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle; or Males must not donate sperm from the first dose of IMP until at least 90 days after the last dose of IMP.\n\nExclusion Criteria:\n\n* Participants will be excluded from the study for any of the following reasons:\n\n  1. Known HER2-positive tumor (HER2-positive is defined as having an IHC score of 3 +, or IHC2 + and positive HER2 expression by in situ hybridization (ISH) (refer to ASCO\u002FCAP guidelines 2020).\n  2. Participants with other malignancies over the past 5 years, except for cured skin basal cell carcinoma, in-situ carcinoma of the cervix, or papillary thyroid cancer.\n  3. Participants who have received radiotherapy or other investigational drug or investigational therapy within 4 weeks prior to the first dose of investigational product.\n  4. Participants who have undergone major surgery (except biopsy) had significant trauma within 4 weeks prior to the first dose of investigational product or required elective surgery during the study.\n  5. Participants with pre-existing \\> Grade 1 peripheral sensory neuropathy (NCI CTCAE 5.0).\n  6. Participants with known hypersensitivity to any components of the investigational product.\n  7. Participants who are pregnant (positive pregnancy test) or lactating.\n  8. Adverse events due to previous anti-tumor therapy have not recovered to CTCAE v5.0 Grade ≤ 1 (except for alopecia and other toxicities judged by the investigator to have no safety risk).\n  9. Participants with esophageal obstruction, pyloric obstruction, intestinal obstruction, or inability to eat on their own after gastrointestinal resection, or other factors that cause difficulty swallowing and inability to take oral drugs.\n  10. Participants with symptomatic\u002Funcontrollable central nervous system metastases or meningeal metastases, including but not limited to those with confirmed metastatic disease progression by examination within 2 months after radiotherapy or other local treatment, or who are ineligible for enrollment as judged by the investigator.\n  11. Participants with uncontrollable bone metastases, i.e., existing or recent fracture risk, recent need for surgery or local radiotherapy, or other crisis conditions as judged by the investigator.\n  12. Participants with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once monthly or more frequently).\n  13. Participants with an active infection and who currently require systematic anti-infective therapy.\n  14. Participants with known history of human immunodeficiency virus (HIV) infection with an exception that if they have not had an opportunistic infection within the past 12 months, they are eligible.\n  15. Participants who are HBV DNA positive or HCV RNA positive (who are HBsAg negative, or HCV antibody negative could be eligible without testing for HBV DNA or HCV RNA).\n  16. Participants with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n      * Patients with severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention or second\u002Fthird-degree atrioventricular block; patients with a mean corrected QT interval (QTcF) \\> 470 msec obtained from three 12-lead electrocardiograms (ECGs) at rest.\n      * Patients who have had an acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥ 3 cardio-cerebrovascular events within 3 months before the first dose.\n      * Patients with clinically uncontrollable hypertension.\n      * Symptomatic Cerebral Infarction\n      * Patients with other cardiac disorders that put the patients at a high risk as judged by the investigator.\n  17. Participants with uncontrolled diabetes mellitus.\n  18. Participants with a mental disorder or poor compliance.\n  19. Participants also participate in another interventional clinical study or receive other study treatments (patients who have discontinued other investigational treatments and are only in the follow-up period are allowed to be enrolled in this study).\n  20. Participants requiring concomitant use of strong CYP3A4 inhibitors or inducers or medications that prolong the QT interval within 14 days prior to the first dose of study treatment and during the study.\n  21. Participants with a history of other systemic severe diseases or abnormal laboratory findings that would, in the Investigator's judgment, be inappropriate for this study.",{"count":96,"type":21},778,[53,98],"PHASE3","This is a multi-national, open-label, randomized, seamless phase II\u002FIII clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma untreated with systemic treatment in advanced setting.",[27],[102,103,104],"UTD2","GC","GEJ","RECRUITING","2025-11-20",{"date":108,"type":32},"2025-11-25",{"date":110,"type":32},"2025-08-28",{"date":112,"type":21},"2030-09-01",{"name":114,"class":115},"Beijing Biostar Pharmaceuticals Co., Ltd.","INDUSTRY",10,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":40},"100601821","phase-2-phase-ii-open-label-multicenter-study-to-evaluate-the-efficacy-and-safety-of-hlx43-an-anti-pd-l1-adc-in-subjects-with-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100601821","NCT07115485","Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;\n* Aged ≥ 18 years AND ≤ 75 years at the time of signing the ICF, male or female;\n* Histologically or cytologically confirmed advanced Gastric or Gastroesophageal Junction Adenocarcinoma\n* Locally advanced or metastatic Gastric or Gastroesophageal Junction Adenocarcinoma that has failed or progressed after at least one standard systemic treatment in the past, or has experienced intolerable toxicity (CTCAE≥ grade 3), or has contraindications to standard treatment and is not suitable for radical treatment.\n* At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to randomization;\n* Subjects who agree to provide archived tumor tissue specimens that meets the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissue for PD-L1 expression testing;\n* The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks (or 5 half-lives of the drug, whichever is shorter) from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological product therapy; at least 2 weeks from the previous hormone therapy or small molecular targeted therapy; at least 1 week from the administration of the traditional Chinese medicine for anti-cancer indications or minor surgery; and recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v5.0, except for Grade 2 peripheral neurotoxicity and alopecia);\n* ECOG PS score of 0-1 within 1 week prior to randomization;\n* Life expectancy \\> 3 months;\n* Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with granulocyte colony-stimulating factor is allowed within 14 days prior to the first dose)\n* Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female subjects of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n* Have previously received any drug treatment targeting topoisomerase I, including chemotherapy and ADC.\n* Radical radiation therapy within 3 months prior to the first dose;\n* History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;\n* History of adverse events leading to permanent discontinuation of immunotherapy, or occurrence of ≥ Grade 2 immune-related pneumonitis or myocarditis during prior immunotherapy;\n* Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n* Active gastrointestinal bleeding (grade ≥2 according to the National Cancer Institute's General Terminology Criteria for Adverse Events \\[CTCAE\\]5.0).\n* Presence of spinal cord compression or clinically active metastases to central nervous system (referring to untreated or symptomatic metastases, or metastases requiring corticosteroids or anticonvulsants to control associated symptoms), carcinomatous meningitis. Subjects who have previously received treatment for brain metastases (such as whole brain radiotherapy or stereotactic brain radiotherapy) may be eligible, provided that they are clinically stable for at least 4 weeks with no imaging evidence of brain metastasis progression;\n* Subjects with current or prior history of clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, and pleural effusion within 3 months prior to the first dose), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of with radiation pneumonitis within 6 months;\n* Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc intervals ≥ 470 ms) (QTc intervals are calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after active treatment);\n* Patients with active systemic infectious diseases requiring intravenous antibiotics or with active tuberculosis within 2 weeks prior to randomization;\n* Patients who have used moderate or potent CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization;\n* Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fd or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids for contrast agents, etc.;\n* Patients with known active or suspected autoimmune diseases. Patients with autoimmune-related hypothyroidism and receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled;\n* Patients who have received live vaccine or live attenuated vaccine within 4 weeks prior to randomization;\n* Patients who are known to have anaphylaxis to macromolecular protein preparations\u002Fmonoclonal antibodies or are allergic to any component in the formulation of the investigational product;\n* Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or history of organ transplantation;\n* Patients with active HBV or HCV infection or HBV\u002FHCV co-infection;\n* Pregnant or lactating women;\n* Patients who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.","18 Days","75 Days",{"count":126,"type":21},60,[53],"The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma",[27],"2025-11-14",{"date":132,"type":32},"2025-11-18",{"date":134,"type":32},"2025-09-15",{"date":136,"type":21},"2028-09-30",{"name":138,"class":115},"Shanghai Henlius Biotech",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100476358","phase-1-spevatamig-pt886-as-monotherapy-or-in-combination-with-chemo-andor-ici-for-the-treatment-of-patients-with-advanced-gastric-gastroesophageal-junction-pancreatic-ductal-or-biliary-tract-carcinomas-the-twinpeak-study-100476358","NCT05482893","Spevatamig (PT886) as Monotherapy or in Combination With Chemo and\u002For ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)","A Phase 1\u002F2, Open-Label, Dose Escalation and Expansion Study With PT886 (Spevatamig) Followed by a Multi-cohorT Study in Patients With Advanced GastrIc, Gastroesophageal JuNction, Pancreatic Ductal or Biliary Tract AdEnocarcinomas of PT886, in Combination With ChemotherApy, and\u002For an Immune ChecKpoint Inhibitor. The TWINPEAK Study","Key Inclusion Criteria\n\n1. 18 years or older and able to sign informed consent and comply with the protocol.\n2. Measurable disease as defined by RECIST V1.1 criteria for solid tumors.\n3. 3\\. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced (metastatic or unresectable) disease or for which treatment is not available or not tolerated.\n\n   Part C, Cohort C1: 2L m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible.\n\n   Part C, Cohort C2: 1L m\u002Fa PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane).\n\n   Part C, Cohort C3: 1L m\u002Fa PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX\u002FmFFX.\n\n   Cohort C4: Patients with m\u002Fa BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment.\n\n   Cohort C5: Patients with m\u002Fa HER2 negative GC\u002FGEJC and present a PD-L1 CPS score of \\\u003C1%, who are treatment naïve for their m\u002Fa disease and eligible for treatment with SOC chemotherapy (mFOLFOX6 or CAPOX).\n\n   Part D, Cohort D2: Patients with m\u002Fa GC\u002FGEJ-C, that have progressed under 1L SOC chemotherapy, and zolbetuximab, will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).\n\n   Part D, Cohort D3: 2L or 3L m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab).\n\n   Part D, Cohort D4: 1L HER2 negative m\u002Fa GC\u002FGEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab).\n4. Biopsies:\n\n   Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be assessed for CLDN18.2 expression and other biomarkers.\n\n   Parts C and D: Patients must present with ≥ 10%; ≥ 2+ CLDN18.2 positive TC in their tumor tissue.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function confirmed at screening and within 72 hours of initiating treatment.\n\nKey Exclusion Criteria\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Women who are pregnant or lactating.\n2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.\n3. Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n4. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to study treatment.\n5. Patients with a history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or have a history of interstitial lung disease. History of COVID-19 pneumonia with fibrotic changes.\n6. Patients with untreated brain or central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain\u002FCNS metastases).\n7. Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents. For Part D, Cohort D2, prior treatment with zolbetuximab is allowed.\n8. Impaired cardiac function or significant diseases.\n9. Prior hemolytic anemia or Evans Syndrome in the last 3 months.\n10. Active gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention.\n11. Patients who have experienced any thromboembolic event such as deep vein thrombosis (DVT) or pulmonary embolism in the past 6 months.\n\nAdditional inclusion and exclusion criteria will apply.",{"count":147,"type":21},258,[24,53],"This is a first-in-human, Phase 1\u002F2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig (PT886). Patients with the following tumor types will be eligible for screening: unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, biliary tract carcinoma (BTC) and pancreatic ductal adenocarcinoma (PDAC).",[27,151,152],"Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer (BTC)","2025-10-31",{"date":155,"type":32},"2025-11-04",{"date":157,"type":32},"2023-03-15",{"date":159,"type":21},"2028-04",{"name":161,"class":115},"Phanes Therapeutics",11,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100604568","phase-2-immunotherapy-combined-with-anti-angiogenic-therapy-and-chemotherapy-for-potentially-resectable-msi-h-dmmr-locally-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100604568","NCT07151209","Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","A Prospective, Multicenter, Open-label Phase II Single-arm Clinical Trial Protocol on the Efficacy and Safety of Lparomlimab and Tuvonralimab in Combination With Lenvatinib and SOX Chemotherapy in Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients","Inclusion Criteria:\n\n* Able to understand and agree to comply with study requirements and the assessment schedule, and voluntarily sign the written informed consent form (ICF) before any trial-related procedures are implemented;\n* Age greater than 18 years, regardless of gender. Histologically confirmed unresectable locally advanced or metastatic G\u002FGEJ adenocarcinoma.\n* No prior systemic treatment for unresectable locally advanced or metastatic G\u002FGEJ adenocarcinoma. Previous neoadjuvant and\u002For adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 6 months prior to the diagnosis of unresectable or metastatic disease.\n* PD-L1 combined positive score (CPS) less than 1 as determined by tissue testing.\n* At least one measurable lesion according to RECIST 1.1 criteria.\n* ECOG performance status 0-1.\n* Life expectancy \\>3 months.\n* Adequate organ and marrow function:\n\nExclusion Criteria:\n\n* 1\\. Known HER2-positive expression (immunohistochemistry \\[IHC\\] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2).\n* Presence of other malignancies within 5 years prior to treatment, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer, and ductal carcinoma in situ (hormone therapy for non-metastatic prostate cancer or breast cancer is permitted).\n* Known central nervous system metastases and\u002For carcinomatous meningitis.\n* Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction.\n* Hypertension that cannot be controlled with antihypertensive medications (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg).\n* History of bleeding within 4 weeks prior to screening, with any bleeding event graded as ≥3 according to CTCAE 5.0.\n* Thrombotic events (arterial or venous) within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (excluding previously thrombosed veins deemed healed by the investigator), and pulmonary embolism.\n* History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n* Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.",{"count":171,"type":21},20,[53],"Efficacy and safety of Iparomlimab and Tuvonralimab in combination with lenvatinib and SOX chemotherapy in potentially resectable MSI-H, dMMR locally advanced gastric or gastroesophageal junction adenocarcinoma patients: A prospective, multicenter, open-label Phase II single-arm clinical trial",[27],[176,177,178],"Iparomlimab and Tuvonralimab","lenvatinib","SOX","2025-09-01",{"date":181,"type":32},"2025-09-03",{"date":183,"type":21},"2025-09",{"date":185,"type":21},"2028-12",{"name":38,"class":39},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":40},"100599956","phase-2-efficacy-and-safety-of-ak112-combined-chemotherapy-as-neoadjuvant-treatment-for-signet-ring-cell-containing-ggej-adenocarcinoma-100599956","NCT07091227","Efficacy and Safety of AK112 Combined Chemotherapy as Neoadjuvant Treatment for Signet Ring Cell-containing G\u002FGEJ Adenocarcinoma","Efficacy and Safety of AK112 Combined Chemotherapy as Neoadjuvant Treatment for Signet Ring Cell-containing Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria\n\n1. Subjects must voluntarily agree to participate in the clinical trial and sign a written informed consent form (ICF) before undergoing any trial-related procedures.\n2. Male or female subjects aged ≥18 and ≤75 years at the time of signing the informed consent.\n3. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with signet ring cell components. Diagnosis of locally advanced disease (based on AJCC 8th edition) must be made within 4 weeks prior to randomization.\n4. Tumor staging: cT3-4a or cN+ (M0) as determined by endoscopic ultrasound and\u002For contrast-enhanced CT\u002FMRI. Diagnostic laparoscopy may be used as needed. The tumor must be assessed as resectable by the investigator.\n5. Immunohistochemical testing confirms proficient mismatch repair (pMMR) status and HER-2 negativity (IHC 0 or 1+, or IHC 2+ with negative FISH for HER-2 amplification).\n6. No prior systemic treatment for the current malignancy, including surgery, chemotherapy, radiotherapy, or immunotherapy.\n7. Eligible for radical surgery with no surgical contraindications as determined by a qualified surgeon.\n8. ECOG performance status of 0 or 1 within 7 days before randomization.\n9. Estimated life expectancy \\> 6 months.\n10. Adequate organ function, as demonstrated by the following laboratory results (without blood product transfusion or cytokine support within 2 weeks prior to first dose):\n\nHematologic: WBC ≥ 3.5 × 10⁹\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, Platelets ≥ 100 × 10⁹\u002FL, Hemoglobin ≥ 90 g\u002FL Hepatic: Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN Renal: Serum creatinine ≤ 1.0 × ULN, Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula) Coagulation: INR, APTT, PT ≤ 1.5 × ULN Thyroid: TSH within normal limits. If TSH is abnormal, subjects with normal total T3 (or FT3) and FT4 may be enrolled.\n\nCardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram; cardiac assessment may be required for patients with cardiac comorbidities.\n\nHepatitis B serology: HBsAg (-) and anti-HBc (-). If HBsAg (+) or anti-HBc (+), HBV-DNA must be \\\u003C1000 copies\u002FmL or \\\u003C200 IU\u002FmL or below the site-specific ULN.\n\nHCV antibody (-). Subjects with positive HCV antibody but negative HCV-RNA may be considered eligible.\n\n11\\) For women of childbearing potential: Negative serum or urine pregnancy test within 7 days before randomization. If urine test is inconclusive, a serum test is required. Postmenopausal status is defined as ≥12 months of amenorrhea or surgical sterilization (bilateral oophorectomy\u002Fhysterectomy).\n\n12\\) Subjects (regardless of sex) with reproductive potential must agree to use highly effective contraception (failure rate \\\u003C1%) from the start of study treatment to 120 days after last study dose (or 180 days if receiving chemotherapy).\n\n13\\) Breastfeeding is not permitted during the study period.\n\nExclusion Criteria\n\n1. Histology other than adenocarcinoma with signet ring cell features, including squamous cell carcinoma, neuroendocrine carcinoma, or other subtypes.\n2. Tumor exhibiting deficient MMR (dMMR) or HER-2 positivity (IHC 3+, or IHC 2+ with FISH-confirmed HER-2 amplification).\n3. Unresectable tumors or subjects unwilling or unable to undergo surgery due to medical, anatomical, or personal reasons.\n4. History of other malignancies within 5 years prior to enrollment, excluding certain cured cancers (e.g., basal cell carcinoma, carcinoma in situ of cervix\u002Fbreast\u002Fprostate\u002Fbladder).\n5. Evidence of active bleeding on endoscopy.\n6. Participation in another interventional clinical study or use of investigational drugs\u002Fdevices within 4 weeks prior to enrollment.\n7. Prior immunotherapy including immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1, anti-CTLA-4, anti-TIGIT, etc.) or cellular immunotherapy.\n8. Use of traditional Chinese medicine with antitumor or immunomodulatory effects within 2 weeks prior to first dose.\n9. Active autoimmune disease requiring systemic therapy in the last 2 years. Hormonal replacement therapies are allowed.\n10. Use of systemic corticosteroids or immunosuppressants within 7 days before first dose (except ≤10 mg\u002Fday prednisone equivalent).\n11. Prior or planned organ\u002Fbone marrow transplantation (excluding corneal transplant).\n12. Known hypersensitivity to investigational products.\n13. Conditions affecting oral administration of capecitabine (e.g., dysphagia, intestinal obstruction).\n14. HIV infection (HIV-1\u002F2 antibody positive).\n15. Active hepatitis B (HBsAg positive and HBV DNA \\> ULN).\n16. Active hepatitis C (HCV antibody positive with detectable HCV RNA).\n17. Receipt of live vaccines within 30 days prior to first dose. Inactivated influenza vaccines are permitted; live attenuated intranasal influenza vaccine is not.\n18. Pregnant or breastfeeding women.\n19. Serious or uncontrolled systemic illnesses, including:\n\n    Significant arrhythmias or heart block\n\n    History of myocarditis, cardiomyopathy, MI, unstable angina, CHF within 12 months\n\n    Gastrointestinal conditions (e.g., active ulcers, varices, perforation, abscess) within 6 months\n\n    Recent COPD exacerbation (within 1 month)\n\n    Grade ≥3 thromboembolic events or cerebrovascular accidents within 6 months\n\n    Poorly controlled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg despite treatment)\n\n    Non-infectious pneumonitis or interstitial lung disease\n\n    Pulmonary tuberculosis\n\n    Active systemic infection\n\n    Decompensated liver disease\n\n    Poorly controlled diabetes (FBG \\>10 mmol\u002FL or random BG \\>16 mmol\u002FL)\n\n    Proteinuria ≥ ++ or 24-hour urine protein \\> 1.0 g\n20. Psychiatric illness interfering with compliance or safety.\n21. Major surgery or significant trauma within 30 days prior to first dose, or planned major surgery within 30 days post first dose (except minor procedures).\n22. Tumor necrosis on imaging, deemed high risk for bleeding by investigator.\n23. History of severe bleeding or coagulation disorders; active bleeding within 1 month (e.g., hematemesis, hemoptysis, significant epistaxis); long-term anticoagulation for atrial fibrillation with CHADS2 ≥ 2.\n24. Any condition or laboratory abnormality that, in the opinion of the investigator, may interfere with the study results or subject safety.",{"count":195,"type":21},66,[53],"Study Overview\n\nThe primary objective of this clinical trial is to evaluate the efficacy and safety of AK112 in combination with chemotherapy as a neoadjuvant treatment for patients with locally advanced, resectable gastric or gastroesophageal junction (G\u002FGEJ) adenocarcinoma containing signet ring cells.\n\nKey Research Questions\n\n1. Does neoadjuvant treatment with AK112 plus chemotherapy improve the pathological complete response (pCR) rate compared to chemotherapy alone in patients with locally advanced G\u002FGEJ adenocarcinoma with signet ring cells?\n2. What are the safety profile and additional efficacy outcomes of AK112 combined with chemotherapy in this patient population?\n\nTo answer these questions, the study will compare the combination of AK112 and chemotherapy with chemotherapy alone.\n\nParticipant Procedures\n\nEligible participants will:\n\n1. Receive standard-dose AK112 in combination with chemotherapy every 3 weeks for a total of 4 cycles prior to surgery.\n2. Undergo preoperative CT or MRI imaging within 3-4 weeks after the last treatment cycle to assess tumor response and evaluate eligibility for curative resection.\n3. If no evidence of disease progression is observed and surgical evaluation is favorable, patients will undergo curative-intent gastrectomy within 6 weeks of completing neoadjuvant therapy (including oral agents, if any).\n4. Postoperatively, adjuvant therapy will be administered at the investigator's discretion. Patients will be followed until disease recurrence or metastasis.\n5. Attend clinic visits every 6 weeks during the neoadjuvant phase for evaluations and laboratory tests.\n6. Maintain a symptom diary throughout the study period.\n7. Undergo follow-up assessments every 3 months, starting from the first dose of study medication until 30 days after the last dose or the initiation of a new anti-tumor therapy.\n\nOptional Imaging Substudy FAPI-PET\u002FCT imaging will be explored as an optional diagnostic modality. Participation in this substudy will require separate informed consent and will be conducted under a future protocol amendment (pending IRB approval).",[27],"2025-07-21",{"date":201,"type":32},"2025-07-29",{"date":203,"type":21},"2025-07-20",{"date":205,"type":21},"2029-07-20",{"name":207,"class":39},"Peking Union Medical College Hospital",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":40},"100561227","phase-2-the-efficacy-and-safety-of-lm-302-in-combination-with-candonilimab-and-capecitabine-for-first-line-treatment-in-patients-with-unresectable-advanced-recurrent-or-metastatic-cldn182-positive-gastric-or-gastroesophageal-junction-adenocarcinoma-100561227","NCT06587425","The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate as participants, and sign an informed consent form (ICF) before any procedures begin\n* The subject must have locally advanced or metastatic gastric cancer or gastroesophageal junction cancer that cannot be surgically removed, and the histopathological examination confirms it to be simple adenocarcinoma\n* Permissible Previous Treatment: Participants with gastric cancer or gastroesophageal junction cancer who have previously received adjuvant or neoadjuvant treatment and have experienced clinical disease progression at least 6 months after the last administration are eligible for inclusion. (Note: The treatment-related toxicity of oxaliplatin in previous adjuvant or neoadjuvant treatments must be restored to the National Cancer Institute \\[NCI\\] General Terminology Standard for Adverse Events \\[CTCAE\\] v5.0 Level 1 before enrollment)\n* CLDN18.2 positivity: Provide sufficient tissue markers for Claudin18.2 immunohistochemistry testing. Claudin18.2 immunohistochemistry expression ≥ 10% is confirmed as positive, and\\<10% is recorded as negative\n* According to RECIST v1.1 standard, there should be at least one measurable lesion\n* ECOG physical state ≤ 1\n* Expected lifespan\\>3 months\n* Adequate renal function: creatinine (Cr) ≤ 1.5 x upper limit of normal (ULN) and glomerular filtration rate (GFR) ≥ 60mL\u002Fmin\u002F1.73 m2;\n* Sufficient liver function: Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN (if there is liver metastasis, AST and ALT ≤ 5 × ULN, total bilirubin ≤ 2.5 × ULN);\n* Adequate bone marrow reserve: Platelet count (PLT) ≥ 100 × 109\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, hemoglobin ≥ 9 g\u002FdL (no adjuvant therapy such as EPO, G-CSF, or GM-CSF has been received within 14 days, and no blood transfusion including red blood cells and platelets has been received at least 7 days before the first administration); Prothrombin time\u002Factivated partial thromboplastin time (PT\u002FPTT)\\<1.5 x ULN;\n* Male or female aged ≥ 18 years old.\n\nExclusion Criteria:\n\n* Known HER2 positive gastric cancer\u002Fadenocarcinoma of the gastroesophageal junction. HER2 positivity refers to HER2 amplification that requires confirmation from ISH if the HER2 immunohistochemistry test result is 3+and the immunohistochemistry test result is 2+\n* Has undergone major surgery or radiation therapy within 4 weeks prior to enrollment;\n* Active, known or suspected autoimmune diseases\n* Congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment\n* A cerebrovascular accident occurred within the past 6 months\n* Clinically significant bleeding, bleeding events, or thromboembolic diseases occur within 6 months\n* History of intestinal perforation\n* Have a history of (non infectious) pneumonia requiring steroid treatment or currently suffer from pneumonia\n* Known history of human immunodeficiency virus (HIV) infection. Subjects with active hepatitis B or active hepatitis C. (Unless receiving antiviral therapy for at least 14 days prior to the first study drug administration and passing hepatitis B virus (HBV) DNA titer testing (not exceeding 500 IU\u002FmL or 2500 copies \\[cps\\]\u002FmL) and hepatitis C virus (HCV) RNA testing (not exceeding the lower limit of the assay), eligible for inclusion in the trial and willing to continue receiving effective antiviral therapy during the study period);\n* Severe impairment of lung function or history of interstitial lung disease\n* Diagnosed with concurrent malignant tumors within the past 2 years (except for fully treated non melanoma skin cancer, superficial bladder transitional cell carcinoma, and cervical carcinoma in situ \\[CIS\\]) or any currently active malignant tumor\n* Previous or current evidence suggests that there may be confusion with the research results, interference with the participant\\'s participation in the entire study process, any conditions, treatments, or laboratory abnormalities, or the researcher believes that participating in this study is not in the best interest of the participant\n* Pregnancy test positive within 7 days before the first administration, or women of childbearing age who are in lactation period\n* Individuals with known mental illnesses or disorders that may affect trial compliance\n* Subjects who take systemic corticosteroids (\\>10 mg daily prednisone equivalent) or other systemic immunosuppressive drugs (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 2 weeks prior to the first medication are allowed to use local, ocular, intra-articular, intranasal, and inhaled corticosteroids\n* Subjects with a known history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Guillain Barre syndrome, multiple sclerosis, or glomerulonephritis, excluding autoimmune hypothyroidism treated with stable dose hormone replacement therapy\n* Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation The researcher determined that there are other situations that are not suitable for participation in this study\n* The researcher determined that there are other situations that are not suitable for participation in this study",{"count":216,"type":21},50,[53],"A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma",[27],[221,222,223,224,225,226,227],"CLDN18.2","ADC drug","cadonilimab","Immune Checkpoint Inhibitor","Targeted therapy","Immunotherapy","Chemotherapy","2024-09-04",{"date":230,"type":32},"2024-09-19",{"date":232,"type":32},"2024-07-31",{"date":234,"type":21},"2026-12-31",{"name":236,"class":39},"Shanghai Zhongshan Hospital"]