[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"afp-gastric-or-gastroesophageal-junction-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:afp-gastric-or-gastroesophageal-junction-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,69],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100632587","phase-2-efficacy-of-sintilimab-combined-with-bevacizumab-and-xeloxsox-in-initially-unresectable-afp-positive-gastricgastroesophageal-junction-adenocarcinoma-100632587",false,"NCT07515625","Efficacy of Sintilimab Combined With Bevacizumab and XELOX\u002FSOX in Initially Unresectable AFP-positive Gastric\u002FGastroesophageal Junction Adenocarcinoma","Conversion Therapy of Sintilimab Combined With Bevacizumab and XELOX\u002FSOX for Initially Unresectable AFP-positive Gastric\u002FEsophagogastric Junction Adenocarcinoma : A Multi-center, Single-arm, Phase II Trial (SOLIDS-02)","Inclusion Criteria:\n\n* Signed informed consent;\n* Patients age 18-75 years;\n* Histologically CT\u002FMRI confirmed cT3-4N+M0\u002F1 gastric or GEJ adenocarcinoma; (M1 only includes type I liver metastasis of gastric cancer, according to the \"Chinese Expert Consensus on Liver Metastasis of Gastric Cancer\");\n* Serum AFP levels \\> 2× upper limit of normal or AFP-positive by IHC staining;\n* Adequate organ function\n* ECOG 0-1, no surgery contraindications;\n* Expected survival ≥3 months;\n\nExclusion Criteria:\n\n* HER2-positive status: IHC 3+, or IHC 2+\u002FFISH+\n* Prior chemotherapy, radiotherapy, anti-PD-1\u002FPD-L1 therapy, surgery for gastric cancer;\n* Signs of other distant metastases (e.g., peritoneal, lung, bone, supraclavicular lymph, etc.)\n* Significant cardiovascular disease\n\n  --Current treatment with anti-viral therapy or HBV\n* Pregnancy or breastfeeding\n* History of malignancy within 5 years prior to screening\n* Present or history of any autoimmune disease or immune deficiency;\n* There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors.","ALL","18 Years","75 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Alpha-fetoprotein-producing gastric cancer (AFP-positive gastric cancer, AFP-GC), a rare and highly aggressive subtype of gastric cancer, accounts for 1.3% to 15% of all gastric cancer cases. Its clinical features are significantly different from those of common gastric cancer. Not only does it show abnormally elevated serum AFP levels, but it also has a stronger angiogenic ability, a higher rate of distant metastasis, and a poorer prognosis even after a upfront R0 surgery, making it a challenging problem in the field of gastric cancer treatment. Notably, patients with AFP-positive gastric cancer have a relatively low sensitivity to the traditional standard regimens. There is an urgent need to explore targeted treatment strategies to break through the efficacy bottleneck.\n\nCombination of sintilimab, bevacizumab and XELOX\u002FSOX for initially unresectable AFP-positive gastric\u002Fesophagogastric junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a multi-center, single-arm phase 2 clinical trial to evaluate efficacy, tolerability and safety of perioperative sintilimab in combination with bevacizumab and XELOX\u002FSOX in initially unresectable AFP-positive gastric\u002Fesophagogastric junction adenocarcinoma.",[27,28],"Gastric Cancer (GC)","AFP Gastric or Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-03-30",{"date":32,"type":33},"2026-04-07","ACTUAL",{"date":35,"type":21},"2026-04-01",{"date":37,"type":21},"2029-04-01",{"name":39,"class":40},"Fudan University","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100615237","phase-2-iparomlimab-and-tuvonralimab-combined-with-apatinib-and-irinotecan-hydrochloride-for-the-treatment-of-advanced-alpha-fetoprotein-producing-gastric-cancer-afpgc-100615237","NCT07289997","Iparomlimab and Tuvonralimab Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC)","Iparomlimab and Tuvonralimab Injection Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC) That Progresses From First-line PD-1 Combined Chemotherapy, A Prospective, Single-arm, Phase II Clinical Study","Inclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form;\n2. Age≥18 years, both male and female are acceptable.\n3. Unresectable，Locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has been diagnosed by histopathological or cytological examination, with serum alpha-fetoprotein \\> 20.0 ng\u002FmL at the time of diagnosis. There is at least one measurable lesion (according to the RECIST v1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10 mm or the short diameter of the enlarged lymph node is ≥15 mm; lesions that have received local treatment in the past can be used as target lesions after comfirmed progression according to the RECIST v1.1).\n4. Failure of previous first-line PD-1 combined chemotherapy treatment (disease progression during or after treatment); Those who relapse within 6 months (less than 183 days) after the end of adjuvant\u002Fneoadjuvant chemotherapy (oxaliplatin combined with fluorouracil) can be included in the study, and PD-1 inhibitors need to be combined in the first-line treatment.\n5. ECOG 0-1;\n6. Expected survival time ≥12 weeks;\n7. The functions of vital organs within 7 days before enrollment meet the following requirements (no blood components or cell growth factors are allowed to be used within 14 days before enrollment) :\n\n   \\\u003C1\\> Absolute neutrophil count ≥1.5×109\u002FL; \\\u003C2\\> platelet count ≥80×109\u002FL; \\\u003C3\\>Hemoglobin ≥9g\u002FdL; \\\u003C4\\>Total bilirubin \\\u003C 1.5 times ULN; \\\u003C5\\>ALT and AST \\\u003C 2.5 times ULN (\\\u003C 5 times ULN in patients with liver metastasis); \\\u003C6\\> serum creatinine ≤1 times ULN; \\\u003C7\\>The endogenous creatinine clearance rate ≥ 50ml\u002Fmin.\n8. Women of childbearing age should take effective contraceptive measures.\n9. Good compliance and cooperation with follow-up visits.\n\nExclusion Criteria:\n\n1. Inability to comply with the research plan or procedures;\n2. It is known to be in a HER2-positive state;\n3. Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other tissue types, or adenocarcinoma mixed with other tissue types of gastric cancer;\n4. The patient currently has any diseases or conditions that affect the absorption of the drug;\n5. Combined with severe cardiovascular diseases, such as uncontrollable heart failure, coronary heart disease, arrhythmia, uncontrollable hypertension, etc.\n6. Patients with active brain metastases. Patients with asymptomatic brain metastases who have not received prior treatment and whose total number of brain metastases is ≤3 and the longest diameter is \\\u003C 1cm can be enrolled. Patients who have previously received treatment for brain metastases can be enrolled if they are clinically stable, have no evidence of new or expanded brain metastases, and have not used steroids for ≥14 days before the study intervention.\n7. Known to be allergic to the drug used in this test;\n8. Previously received immune checkpoint inhibitors other than anti-PD-1 \u002FPD-L1 antibodies or other drugs\u002Fantibodies acting on T-cell co-stimulation or checkpoint pathways;\n9. Significant clinically significant bleeding symptoms or a clear bleeding tendency occurred within 3 months before enrollment; Gastrointestinal perforation and\u002For gastrointestinal fistula occurred within 6 months before enrollment; Arterial\u002Fvenous thrombotic events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.\n10. Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or hepatitis C (previous history of hepatitis B virus infection regardless of drug control, hepatitis B virus DNA≥1×104 copies \u002FmL or 2000 IU\u002Fml);\n11. Known history of primary immunodeficiency or active pulmonary tuberculosis;\n12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n13. There is a known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive);\n14. Significant malnutrition (weight loss of 5% within one month of signing the informed consent form or 15% within three months, or a reduction of half or more in food intake within one week), except for more than four weeks after the correction of malnutrition before the administration of the first dose of the study drug;\n15. History of other primary malignant tumors, excluding:\n\n    \\\u003C1\\>Malignant tumors that achieved complete remission for at least 2 years before enrollment and did not require additional treatment during the study period; \\\u003C2\\>Non-melanoma skin cancer or malignant freckle-like nevus that has been fully treated and has no evidence of disease recurrence; \\\u003C3\\>Carcinoma in situ that has received adequate treatment and has no evidence of disease recurrence.\n16. Female patients who are pregnant or breastfeeding;\n17. According to the researcher's judgment, those with concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study;\n18. The researchers considered patients unsuitable for inclusion in this study.",{"count":49,"type":21},39,[24],"This study is a single-arm study aimed at evaluating the efficacy and safety of Iparomlimab and Tuvonralimab Injection combined with apatinib and irinotecan hydrochloride in the treatment of advanced alpha-fetoprotein gastric cancer (AFPGC) that progresses from first-line PD-1 combined with chemotherapy. The study enrolled patients with advanced gastric cancer and gastroesophageal junction cancer whose serum alpha-fetoprotein was greater than 20.0 ng\u002FmL at the initial diagnosis and progressed after first-line PD-1 combined chemotherapy in a single center of the Fourth Hospital of Hebei Medical University. All patients underwent gastroscopy and were pathologically confirmed as Her-2 negative gastric adenocarcinoma, and had received PD-1 inhibitor treatment as the first-line treatment. Staged examinations include enhanced CT of the abdominal and pelvic cavities, plain CT scan of the chest, and color Doppler ultrasound of superficial lymph nodes. The enrolled patients received apalolitovolrelimab 5.0mg\u002Fkg, Q3W, d1; Apatinib mesylate, 0.25g, once daily; Irinotecan hydrochloride, 200mg\u002Fm², Q3W, d1. Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years.\n\nThe primary endpoint of the study was to assess the objective response rate (ORR) of combination therapy. Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and the incidence of adverse events, etc",[28,53,54,55],"PD-1\u002FCTLA-4","AFPGC","Immunotherapy",[57,54,53],"immunotherapy","RECRUITING","2025-12-04",{"date":61,"type":33},"2025-12-17",{"date":63,"type":33},"2025-09-28",{"date":65,"type":21},"2028-09",{"name":67,"class":40},"Hebei Medical University Fourth Hospital",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100590892","phase-2-sintilimab-plus-apatinib-and-sox-as-first-line-treatment-in-patients-with-afp-gastric-or-gastroesophageal-junction-adenocarcinoma-100590892","NCT06973330","Sintilimab Plus Apatinib and SOX as First-line Treatment in Patients With AFP Gastric or Gastroesophageal Junction Adenocarcinoma","Sintilimab Plus Apatinib and SOX as First-line Treatment in Patients With AFP Gastric or Gastroesophageal Junction Adenocarcinoma: a Single-arm, Multi-center, Phase II Trial","Inclusion Criteria:\n\n1. Male or female patients ≥18 years old;\n2. Patients with advanced \u002F metastatic gastric cancer diagnosed by histopathology, without liver like differentiation, HER-2 negative, serum AFP ≥ 2xULN or AFP positive by the IHC staining;\n3. No previous palliative systemic treatment;\n4. There are measurable metastatic lesions according to RECIST version 1.1;\n5. ECOG physical status score is 0 or 1；\n6. Normal organ function: Neutrophil count ≥ 1.2 × 109\u002FL, Platelet count ≥ 100 × 109\u002FL, Hemoglobin (HB) ≥ 80g\u002FL, Total bilirubin ≤ 1.5mg\u002Fdl, AST and ALT ≤ 100 IU\u002FL. If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤ 200 IU\u002FL, Creatinine ≤ 1.5 times\\* upper limit of normal, International standardization ratio (INR) ≤ 1.5;\n7. Urinary protein: meet one of the following conditions Urinary protein (test paper method) is 2 + or less, Urinary protein\u002Fcreatinine (UPC) ratio \\\u003C 3.5, Determination of 24-hour urinary protein, urinary protein ≤ 3500mg;\n8. Before receiving treatment, the patient has recovered the adverse events related to chemotherapy, radiotherapy and surgery to grade 1 or below (CTCAE 5.0);\n9. For women with fertility potential with negative pregnancy test within 14 days before enrollment, male and female patients should agree to use appropriate contraceptive methods from the beginning of the first treatment to 120 days after the last treatment;\n10. Patients who can take oral drugs;\n11. Signed the informed consent.\n\nExclusion Criteria:\n\n1. Patients who received surgery and radiotherapy within 2 weeks before enrollment;\n2. Patients who have previously been treated with Apatinib or any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs;\n3. Patients with uncontrollable hypertension (systolic blood pressure ≥ 160mmHg and diastolic blood pressure ≥ 90mmHg);\n4. Patients with acute coronary syndrome (including myocardial infarction and unstable angina) who had undergone coronary angioplasty within 6 months before enrollment;\n5. Patients with symptomatic brain metastases;\n6. Patients with New York Heart Association (NYHA) grade II or above congestive heart failure or severe arrhythmia with severe cardiovascular damage in the past 6 months;\n7. The patients had active malignancies in the past 24 months (except for melanoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma or carcinoma in situ of the cervix) ;\n8. The patients have severe (hospitalized) complications;\n9. Patients with a history of gastrointestinal perforation and\u002For gastrointestinal fistula within 6 months before enrollment;\n10. Patients with active hepatitis;\n11. Patients with a history of human immunodeficiency virus (HIV) infection; 12. Patients with symptoms or signs of active interstitial pulmonary disease; 13. Patients with autoimmune diseases or a history of chronic or recurrent autoimmune diseases;\n\n14\\. Patients who need systemic corticosteroids (excluding temporary use for testing, prophylactic administration of allergic reactions or reduction of swelling associated with radiotherapy) or immunosuppressants, or patients who receive such treatment within 14 days before enrollment; 15. The patient has a history of (non-infectious) pneumonia requiring steroids or has a current history of pneumonia; 16. Patients who received live vaccine \\\u003C 30 days before starting trial drug treatment; The patient has serious non-healing wounds, ulcers or fractures; 17. Pregnant or lactating women; 18. The investigator determined that the patient is not suitable to be the subject of this trial; 19. Other circumstances that the investigator considers inappropriate to participate in the clinical trial.",{"count":77,"type":21},40,[24],"This is a multi-center, prospective, open label phase II study evaluating the safety and efficacy of standard first-line chemotherapy SOX regimen combined with Sintilimab (anti-PD-1 antibody) and Apatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Anhui Provincial Cancer Hospital. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with SOX regimen combined with Sintilimab plus Apatinib every 3 weeks(4 cycles) followed by sintilimab+apatinib until disease progression or intolerable adverse reactions or death(up to 24 months).Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.",[28],"2025-06-12",{"date":83,"type":33},"2025-06-15",{"date":85,"type":21},"2025-07",{"date":87,"type":21},"2027-05-01",{"name":89,"class":40},"Anhui Provincial Cancer Hospital"]