[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fruquintinib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fruquintinib":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,81,105,128],{"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":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100618654","phase-1-fruquintinib-combined-with-trastuzumab-and-xelox-as-first-line-treatment-in-patients-with-her2-positive-advanced-gastric-cancer-100618654",false,"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.","ALL","18 Years","75 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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.",[28,29,30,31,32,33],"Gastric Adenocarcinoma","Gastric (Stomach) Cancer","GEJ Adenocarcinoma","HER2-positive Gastric Cancer","First-line Therapy","Fruquintinib","RECRUITING","2025-12-30",{"date":37,"type":38},"2026-01-12","ACTUAL",{"date":40,"type":38},"2024-02-22",{"date":42,"type":21},"2026-12-31",{"name":44,"class":45},"Henan Cancer Hospital","OTHER_GOV",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":46},"100612751","phase-2-the-safety-and-efficacy-of-cetuximab-beta-plus-fruquintinib-with-or-without-immune-checkpoint-inhibitorrs-in-first-line-treatment-of-rasbraf-wild-type-unresectable-metastatic-colorectal-cancer-100612751","NCT07257653","The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS\u002FBRAF Wild Type Unresectable Metastatic Colorectal Cancer","concept","Inclusion Criteria:\n\n1）Subjects voluntarily join this study, sign the informed consent form, and demonstrate good compliance; 2) Age: 10-80 years old, ECOG PS score of 0-1. For patients aged 80-85, comprehensive functional assessments must be completed, and they may be enrolled if the investigator deems them tolerable, with an expected survival of over 3 months; 3) Histopathologically and\u002For cytologically confirmed, unresectable metastatic colorectal adenocarcinoma confirmed by MDT discussion (UICC\u002FAJCC TNM staging system for colorectal cancer, 8th Edition, 2017); 4) At least one measurable lesion confirmed according to RECIST 1.1 criteria; 5) Adequate function of major organs, meeting the following criteria:\n\n1. Hematological examination standards (no blood transfusion or use of hematopoietic growth factors for correction within 7 days prior to screening):\n\n   1. Hemoglobin (HGB) ≥ 90 g\u002FL;\n   2. Absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹\u002FL;\n   3. Platelet count (PLT) ≥ 75 × 10⁹\u002FL;\n2. Biochemical tests must meet the following criteria:\n\n   1. Total bilirubin (TBIL) ≤ 1.5 × ULN (≤ 3 × ULN for subjects with Gilbert's syndrome);\n   2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. If with liver metastases, ALT and AST ≤ 5 × ULN;\n   3. Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 50 ml\u002Fmin.\n3. Coagulation function or thyroid function tests must meet the following criteria:\n\n   1. Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant therapy);\n   2. Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be assessed (FT3 and FT4 may be substituted if T3\u002FT4 are unavailable at the center). Subjects may be enrolled if T3 and T4 levels are normal.\n4. Echocardiogram assessment: Left ventricular ejection fraction (LVEF) ≥ 50%.\n5. Hepatitis B surface antigen (HBsAg) negative. If HBsAg positive, hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be \\\u003C 2500 copies\u002FmL or 500 IU\u002FmL for enrollment.\n6. HCV antibody negative or HCV-RNA negative subjects may enroll; if HCV-RNA positive, subjects must have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN to enroll. Subjects with co-infection of hepatitis B and hepatitis C are excluded (positive for HBsAg or HBcAb, and positive for HCV antibody).\n7. Female patients must meet one of the following conditions:\n\n   1. Postmenopausal (defined as no menses for at least 1 year, with no other confirmed causes besides menopause), or\n   2. Surgically sterilized (removal of ovaries and\u002For uterus), or\n   3. Of childbearing potential but must meet the following:\n\n      * Serum\u002Furine pregnancy test within 7 days prior to enrollment must be negative;\n      * Agree to use contraception with a failure rate of \\\u003C 1% per year or maintain abstinence (avoiding heterosexual intercourse) (from signing the ICF until at least 6 months after the last dose of the study drug) (contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, copper intrauterine devices, or condoms);\n      * Must not be breastfeeding.\n8. Male patients must meet the following: Agree to abstinence (avoiding heterosexual intercourse) or use contraception, as specified: When the partner is a woman of childbearing potential or is pregnant, the male patient must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose to prevent fetal drug exposure. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Presence of MSI-H\u002FdMMR patients.\n2. Concurrent diseases and medical history:\n\n   1. Diagnosis of or concurrent other malignancies within the past 3 years. The following conditions are eligible for enrollment:\n\n      Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\];\n   2. Multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);\n   3. History or tendency of gastrointestinal bleeding or perforation within 4 weeks prior to enrollment;\n   4. Patients with active inflammatory bowel disease within 4 weeks prior to enrollment;\n   5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n   6. Unresolved toxicities from any prior antitumor therapy exceeding CTCAE Grade 1 (excluding alopecia and oxaliplatin-induced neurotoxicity ≤ Grade 2);\n   7. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment (excluding gastrointestinal endoscopic biopsy);\n   8. Symptoms of active bleeding within 1 week prior to screening, without significant improvement or control;\n   9. Patients with any bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to study initiation, or presence of unhealed wounds, ulcers, or fractures;\n   10. Arterial\u002Fvenous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n   11. History of psychoactive drug abuse with inability to abstain;\n   12. Patients with any severe and\u002For uncontrolled diseases, including:\n\n       * Uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after standard antihypertensive therapy);\n       * Myocardial ischemia ≥ Grade 2, myocardial infarction, arrhythmias (including QTc ≥450 ms for males, QTc ≥470 ms for females), and congestive heart failure ≥ Grade 2 (New York Heart Association (NYHA) classification);\n       * Active or uncontrolled severe infections (≥ CTCAE Grade 2 infection);\n       * Liver cirrhosis, active hepatitis\\*; (\\*Active hepatitis \\[Hepatitis B reference: HBsAg positive and HBV DNA positive (\\>2500 copies\u002FmL or \\>500 IU\u002FmL); Hepatitis C reference: HCV antibody positive and HCV viral titer above the upper limit of normal\\]. Note: Eligible HBsAg-positive or HBcAb-positive subjects and hepatitis C patients require continuous antiviral therapy to prevent viral reactivation.)\n       * Renal failure requiring hemodialysis or peritoneal dialysis;\n       * History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n       * Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL);\n       * Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein quantification \\>1.0 g;\n       * History of clear neurological or psychiatric disorders, including epilepsy or dementia requiring treatment.\n   13. Patients with known active or suspected autoimmune diseases. Patients with immune-related hypothyroidism requiring thyroid hormone replacement therapy and well-controlled type I diabetes are allowed. Patients with vitiligo requiring no intervention or resolved childhood asthma\u002Fallergies requiring no intervention in adulthood are allowed.\n\n       * Receipt of live vaccines within 28 days prior to enrollment. However, inactivated viral vaccines for seasonal influenza are permitted, while live attenuated influenza vaccines administered intranasally are not allowed.\n       * Patients requiring systemic glucocorticoids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive drugs within 14 days prior to enrollment or during the study. The following conditions are allowed for enrollment:\n       * Use of topical or inhaled glucocorticoids in the absence of active autoimmune diseases;\n       * Adrenal glucocorticoid replacement therapy at doses ≤10 mg\u002Fday prednisone equivalent.\n   14. Participation in other clinical studies or initiation of study treatment within 14 days after the end of prior clinical study treatment. History of severe allergy to any monoclonal antibody.\n3. Tumor-related symptoms and treatment:\n\n   1. Surgery (excluding prior diagnostic biopsies), radiotherapy, chemotherapy, or other anticancer therapies within 4 weeks prior to the start of study treatment (calculated from the end date of the last treatment as the washout period);\n   2. Prior postoperative adjuvant therapy containing anti-angiogenic targeted drugs (including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, etc.);\n\n   d) Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months;\n4. Patients deemed by the investigator to have concomitant diseases that seriously endanger subject safety or affect study completion, or who are otherwise considered unsuitable for enrollment.","10 Years","85 Years",{"count":57,"type":21},70,[25],"Colorectal cancer is a malignant tumor ranking among the top four in incidence and the top three in causes of death globally . Chemotherapy combined with anti-EGFR or anti-VEGF monoclonal antibodies is currently the standard first-line treatment for advanced pMMR colorectal cancer. The inclusion of anti-EGFR or anti-VEGF targeted therapies has improved the overall survival of advanced colorectal cancer patients from 13 months in the era of fluorouracil monotherapy to the current 30 months.\n\nHowever, many patients refuse chemotherapy or cannot tolerate cytotoxic chemotherapeutic drugs, which often leads to poor prognosis in advanced colorectal cancer. Thus, in the treatment of advanced colorectal cancer, is it possible to achieve antitumor activity through the combination of targeted drugs while avoiding chemotherapy?\n\nEarly clinical studies evaluated the possibility of combining anti-EGFR and anti-VEGF monoclonal antibodies. Subsequent large-scale Phase III clinical studies, such as PACCE , indicated that the combination of FOLFOX or FOLFIRI regimens with bevacizumab and panitumumab increased adverse reactions without providing survival benefits in the overall colorectal cancer population compared to the control group. Following this, the CAIRO2 clinical study added cetuximab to CapeOX combined with bevacizumab and still did not demonstrate survival benefits in the first-line treatment of advanced colorectal cancer, particularly in patients with RAS mutations. However, subgroup analyses suggested a certain survival advantage in patients with wild-type RAS who received combined targeted therapy. A recent clinical study (ECOG-ACRIN E7208) showed that in patients with KRAS wild-type advanced colorectal cancer, second-line use of irinotecan combined with cetuximab and ramucirumab significantly improved progression-free survival (PFS) and disease control rate (DCR) compared to cetuximab combined with irinotecan. These studies suggest that combining anti-EGFR and anti-VEGF monoclonal antibodies is a feasible approach for patients with wild-type RAS\n\nCertainly, in terms of anti-VEGF options, besides macromolecular anti-VEGFR monoclonal antibodies, small-molecule tyrosine kinase inhibitors targeting VEGF have also demonstrated significant antitumor activity in colorectal cancer. Studies have shown that fruquintinib significantly prolongs the survival of patients with advanced colorectal cancer, leading to its approval as a third-line treatment for colorectal cancer.\n\nOn the other hand, immunotherapy targeting PD-1 and CTLA-4 has recently made significant progress in the treatment of colorectal cancer. For the pMMR type, which accounts for over 90% of advanced colorectal cancer cases, related clinical studies have confirmed that the combination of immunotherapy and targeted therapy has significant antitumor synergistic effects. These studies also indicate that immune checkpoint inhibitors can enhance the antitumor activity of anti-EGFR and anti-VEGF targeted therapies in pMMR advanced colorectal cancer.\n\nThis study aims to evaluate the efficacy and safety of cetuximab combined with fruquintinib, with or without immune checkpoint inhibitors, as a first-line treatment for pMMR, RAS\u002FBRAF wild-type metastatic colorectal cancer.",[61,62,63,64,33],"Colorectal Neoplasms","RAS","BRAF","Cetuximabβ",[66,67,68,69,70],"Colorectal cancer","Chemotherapy-free","KRAS\u002FNRAS\u002FBRAF wild-type","cetuximab combined with fruquintinib","with or without immune checkpoint inhibitors","2025-11-20",{"date":73,"type":38},"2025-12-02",{"date":75,"type":38},"2025-10-21",{"date":77,"type":21},"2027-12-31",{"name":79,"class":80},"Zhejiang University","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":103,"locationsCount":4},"100604090","maic-of-fruquintinib-plus-paclitaxel-versus-ramucirumab-plus-paclitaxel-in-advanced-ggej-adenocarcinoma-100604090","NCT07144995","MAIC of Fruquintinib Plus Paclitaxel Versus Ramucirumab Plus Paclitaxel in Advanced G\u002FGEJ Adenocarcinoma","Adjusted Indirect Treatment Comparison of Fruquintinib-based Therapy Versus Standard Care in Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: A MAIC Analysis.","Inclusion Criteria:\n\n* Histologically confirmed gastric\u002FGEJ adenocarcinoma\n* Advanced or metastatic disease\n* ECOG 0-1\n* Received either fruquintinib + paclitaxel or reference regimen\n* Available baseline characteristics for matching variables\n\nExclusion Criteria:\n\n* Missing key outcome data\n* Incomplete baseline characteristics for \\>2 matching variables\n* Prior fruquintinib exposure (control arm only)",{"count":89,"type":21},1143,"OBSERVATIONAL","This anchored matching-adjusted indirect comparison (MAIC) evaluates the relative efficacy of fruquintinib-paclitaxel (using IPD from the FRUTIGA trial, n=703) versus ramucirumab-paclitaxel (using published AgD from RAINBOW-Asia, n=440) in advanced gastric\u002FGEJ adenocarcinoma. Baseline characteristics are adjusted via entropy balancing weights. Primary endpoint is progression-free survival (PFS) analyzed by Bucher method; secondary endpoints include overall survival (OS) and objective response rate (ORR). Sensitivity analyses comprise restricted mean survival time (RMST) analysis and simulated treatment comparison (STC).",[93,94,33,95],"Advanced Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Ramucirumab","NOT_YET_RECRUITING","2025-08-20",{"date":99,"type":38},"2025-08-28",{"date":101,"type":21},"2025-09-05",{"date":42,"type":21},{"name":104,"class":80},"Sun Yat-sen University",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":46},"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":113,"type":21},55,[25],"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.",[28,30,32,117,33,118],"Maintenance Therapy","PD-1","2025-03-20",{"date":121,"type":38},"2025-03-21",{"date":123,"type":21},"2025-03-31",{"date":125,"type":21},"2028-12-31",{"name":127,"class":80},"Ruijin Hospital",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":148,"locationsCount":46},"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":136,"type":21},44,[24,25],"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.",[29,28,33,140,141,30],"PD-1 Inhibitor","Tislelizumab","2025-03-11",{"date":144,"type":38},"2025-03-12",{"date":146,"type":21},"2025-03-01",{"date":125,"type":21},{"name":149,"class":80},"Sixth Affiliated Hospital, Sun Yat-sen University"]