[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659672":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":23,"studyPopulation":11,"armGroups":24,"interventions":32,"overallOfficials":42,"centralContacts":46,"locations":51,"responsibleParty":68,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1",null,"Baseline through pre-surgical restaging (after 4 neoadjuvant cycles of 21 days each; approximately 12 weeks from first dose)",[14],{"measure":15,"description":11,"timeFrame":12},"Disease Control Rate (DCR), Defined as Complete Response + Partial Response + Stable Disease per RECIST v1.1",{"allocation":17,"interventionModel":18,"interventionModelDescription":19,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"NA","SINGLE_GROUP","Single-center, prospective, open-label phase 2 study conducted under a single-group assignment model. All eligible participants receive the identical neoadjuvant combination (iparomlimab and tuvonralimab plus nab-P-SOX); there is no randomization, no placebo, and no parallel comparator arm. Each patient serves as their own control through paired assessment of baseline tumor staging and post-neoadjuvant surgical pathology (a within-subject, before-and-after design). No stratification, blocking, or alternate treatment allocation beyond the single experimental cohort is applied.","TREATMENT",{"masking":22,"maskingDescription":11,"whoMasked":11},"NONE","Background and Rationale Gastric and gastroesophageal junction (GEJ) adenocarcinoma remains a leading cause of cancer mortality, and patients with locally advanced disease (cT3-4aN+M0) face a high risk of recurrence even after curative-intent surgery. Neoadjuvant systemic therapy is the established strategy to improve R0 resection rates and long-term outcomes. Although PD-1\u002FPD-L1 immune checkpoint inhibitors have entered the treatment landscape of advanced gastric cancer, the incremental value of CTLA-4 blockade in the perioperative setting remains an active question. Iparomlimab and tuvonralimab (QL1706; trade name Qibain®) is a bispecific antibody that concurrently engages PD-1 and CTLA-4, potentially enhancing T-cell activation within the tumor microenvironment. Preclinical and early clinical evidence suggests that a chemotherapy backbone can potentiate immunotherapy activity. This study investigates whether neoadjuvant iparomlimab and tuvonralimab combined with the nab-P-SOX regimen (nab-paclitaxel, oxaliplatin, and S-1) improves tumor response and resectability in locally advanced, HER2-negative gastric\u002FGEJ adenocarcinoma.\n\nStudy Design and Procedures This is a prospective, single-center, single-arm, open-label, phase 2 study. Eligible participants (see Eligibility) will receive neoadjuvant iparomlimab and tuvonralimab in combination with P-SOX for a protocol-defined number of cycles, followed by restaging and curative-intent surgery with standardized pathological assessment of the surgical specimen. Postoperative management follows institutional practice. Participants are followed through scheduled visits for efficacy and safety; tumor response is evaluated by imaging and surgical pathology, and adverse events are graded per CTCAE (full intervention details, dosing, and schedule are provided in the Arms and Interventions section).\n\nObjectives The primary objective is to evaluate the antitumor activity of the neoadjuvant regimen. Secondary objectives assess pathological response, resectability, survival, and safety. Formal endpoint definitions, assessment time points, and the statistical analysis plan-including sample size justification and methods for handling the single-arm design-are detailed in the Outcomes and statistical sections and are not repeated here. Exploratory analyses will examine candidate biomarkers potentially associated with treatment response.",[25],{"label":26,"type":27,"description":28,"interventionNames":29},"Iparomlimab and Tuvonralimab Plus nab-P-SOX as Neoadjuvant Therapy","EXPERIMENTAL","All participants in this single experimental arm receive neoadjuvant therapy with iparomlimab and tuvonralimab (QL1706; trade name Qibain®) in combination with the nab-P-SOX chemotherapy regimen, administered as 4 cycles on a 21-day schedule, followed by curative-intent surgery. On Day 1 of each 21-day cycle:\n\nIparomlimab and tuvonralimab: 5 mg\u002Fkg by intravenous (IV) infusion; Nab-paclitaxel (albumin-bound paclitaxel): 150 mg\u002Fm² IV; Oxaliplatin: 130 mg\u002Fm² IV; S-1 (tegafur\u002Fgimeracil\u002Foteracil): oral, twice daily on Days 1-14, with dose by body-surface area (\\\u003C1.25 m²: 40 mg\u002Fdose; 1.25-1.5 m²: 50 mg\u002Fdose; \\>1.5 m²: 60 mg\u002Fdose).\n\nCurative-intent surgery is performed within 4 weeks after the last neoadjuvant cycle. Postoperative adjuvant treatment is left to the investigator's discretion. Dose interruptions, reductions, or permanent discontinuation follow the protocol's toxicity management rules (NCI CTCAE v5.0); dose is not re-escalated after reduction.",[30,31],"Drug: Iparomlimab and Tuvonralimab (QL1706)","Drug: nab-P-SOX（nab-paclitaxel, oxaliplatin, S-1）",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"DRUG","Iparomlimab and Tuvonralimab (QL1706)","A recombined anti-PD-1\u002FCTLA-4 bispecific antibody (development code QL1706) administered at a fixed dose of 5 mg\u002Fkg by intravenous infusion on Day 1 of each 21-day cycle for 4 cycles. This agent is distinguished from conventional immunotherapy by concurrently targeting both PD-1 and CTLA-4 inhibitory pathways within a single molecule, in contrast to sequential or separate use of a PD-1 inhibitor plus ipilimumab (CTLA-4 inhibitor). It is explored here in the neoadjuvant (pre-surgical) window rather than in the metastatic or adjuvant setting.",[26],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"nab-P-SOX（nab-paclitaxel, oxaliplatin, S-1）","A triplet chemotherapy backbone given on Day 1 of each 21-day cycle for 4 cycles: nab-paclitaxel 150 mg\u002Fm² IV, oxaliplatin 130 mg\u002Fm² IV, plus S-1 (tegafur\u002Fgimeracil\u002Foteracil) orally 40-60 mg twice daily on Days 1-14 (dose by BSA). This regimen is distinguished from the more common SOX (S-1 + oxaliplatin) or mFOLFOX by the addition of albumin-bound paclitaxel to form a three-drug triplet, and by the inclusion of S-1, an oral fluoropyrimidine more commonly used in Asian gastric-cancer populations.",[26],[43],{"name":44,"affiliation":5,"role":45},"Hao Li","PRINCIPAL_INVESTIGATOR",[47],{"name":44,"role":48,"phone":49,"phoneExt":11,"email":50},"CONTACT","86-21-64370045","lh11001@rjh.com.cn",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Shanghai Jiaotong Univeristy School of Medicine Affiliated Ruijin Hospital","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":61,"coordinates":62},"Point",[63,64],121.45806,31.22222,{"lat":64,"lon":63},[67],{"name":44,"role":48,"phone":49,"phoneExt":11,"email":50},{"type":69,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[71],{"name":72,"class":73},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY","100659672","phase-2-neoadjuvant-iparomlimab-and-tuvonralimab-with-nab-p-sox-in-locally-advanced-gastric-or-gastroesophageal-junction-cancer-100659672",false,"NCT07867392","Neoadjuvant Iparomlimab and Tuvonralimab With Nab-P-SOX in Locally Advanced Gastric or Gastroesophageal Junction Cancer","Iparomlimab and Tuvonralimab in Combination With Albumin-Bound Paclitaxel, Oxaliplatin, and S-1 as Neoadjuvant Therapy for Locally Advanced Gastric or Gastroesophageal Junction Cancer: A Single-center, Single-arm, Prospective, Open-label, Phase 2 Clinical Study","Inclusion Criteria:\n\n* 1\\. Age 18-75 years. 2. Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma, with clinical stage cT3-4aN+M0.\n\n  3\\. Resectable disease, as determined by the surgical investigator. 4. No prior radiotherapy, chemotherapy, or other systemic antitumor therapy. 5. HER-2 negative. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 7. Life expectancy \\> 6 months. 8. Adequate organ function, defined as: hemoglobin (Hb) ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count (PLT) ≥ 100 × 10⁹\u002FL, serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), alanine\u002Faspartate aminotransferase (ALT\u002FAST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN, amylase\u002Flipase \\\u003C 1.5 × ULN, international normalized ratio (INR)\u002Factivated partial thromboplastin time (APTT) ≤ 1.5 × ULN, urine protein \\\u003C 2+, left ventricular ejection fraction (LVEF) ≥ 50%, etc.\n\n  9\\. Women of childbearing potential must be non-pregnant, non-lactating, and agree to use adequate contraception.\n\n  10\\. Voluntary provision of written informed consent, with good treatment compliance anticipated.\n\nExclusion Criteria:\n\n* 1\\. Known allergy or hypersensitivity to the investigational drug(s) or any of their excipients.\n\n  2\\. History of other prior antitumor therapy. 3. Therapeutic full-dose anticoagulation or thrombolysis within 10 days prior to the first dose.\n\n  4\\. Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks prior to the first dose.\n\n  5\\. Active autoimmune disease, or an autoimmune disease with a high risk of relapse upon immunosuppression.\n\n  6\\. Within 6 months: gastrointestinal perforation, fistula, or obstruction; Crohn's disease or ulcerative colitis; or extensive intestinal resection.\n\n  7\\. Symptomatic and uncontrolled brain or leptomeningeal metastases. 8. History of interstitial lung disease\u002Fpneumonitis, or pulmonary hypertension. 9. History of organ transplantation. 10. Uncontrolled hypertension (\\>150\u002F100 mmHg), diabetes mellitus, or cardiac arrhythmia.\n\n  11\\. Arterial or venous thrombotic\u002Fembolic event within 6 months. 12. Within 12 months: myocardial infarction, unstable angina, or New York Heart Association (NYHA) class III\u002FIV heart failure.\n\n  13\\. Drainage of ascites, pleural effusion, or pericardial effusion within 4 weeks prior to enrollment.\n\n  14\\. Non-healing wound, active ulcer, or untreated fracture. 15. Other active malignancy (except cured basal\u002Fsquamous cell skin carcinoma or in situ carcinoma).\n\n  16\\. Active HIV, HBV, or HCV infection. 17. Major surgery within 4 weeks prior to the first dose. 18. Any other condition that, in the investigator's judgment, renders the patient unsuitable for study participation.","ALL","18 Years","75 Years",{"count":85,"type":86},28,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","This is a single-center, single-arm, phase 2 clinical study testing a new neoadjuvant (pre-surgery) treatment for patients with locally advanced gastric cancer or gastroesophageal junction (GEJ) cancer. The treatment combines two parts: (1) a novel bispecific immunotherapy drug, iparomlimab and tuvonralimab (Qibain®) , which helps the immune system attack cancer cells by blocking the PD-1 and CTLA-4 pathways; and (2) a standard chemotherapy regimen called nab-P-SOX, made up of nab-paclitaxel, oxaliplatin, and S-1.\n\nAbout 28 adults (aged 18-75) with previously untreated, HER2-negative, locally advanced gastric or GEJ adenocarcinoma (clinical stage cT3-4aN+M0) will receive this combination before their planned surgery. The main goal is to see how well the tumor shrinks, measured by the objective response rate (RECIST v1.1). Secondary goals include the rate of complete response in the removed tumor tissue (pathological complete response), how often the cancer is removed with clear margins (R0 resection), survival outcomes, and the safety of the treatment. All participants will be closely followed to track both benefits and side effects. The study is sponsored by Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, with funding and the study drug provided by Qilu Pharmaceutical Co., Ltd.",[92],"Gastric Adenocarcinoma",[94,95,96,97,98,99,100],"Gastroesophageal Junction Cancer","Neoadjuvant Therapy","Iparomlimab and Tuvonralimab","PD-1\u002FCTLA-4 Bispecific Antibody","Nab-paclitaxel","Oxaliplatin","S-1","2026-10-05",{"date":103,"type":104},"2026-10-09","ACTUAL",{"date":106,"type":104},"2025-02-01",{"date":108,"type":86},"2030-02-01",{"name":5,"class":6},1]