RECRUITING Phase 2 ClinicalTrials.gov

Neoadjuvant Iparomlimab and Tuvonralimab With Nab-P-SOX in Locally Advanced Gastric or Gastroesophageal Junction Cancer

Sponsor: Ruijin Hospital • ClinicalTrials.gov ID: NCT07867392

Registry updated: 2026-10-13

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Description

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. About 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.

Interventions

Iparomlimab and Tuvonralimab (QL1706) (Drug)
A recombined anti-PD-1/CTLA-4 bispecific antibody (development code QL1706) administered at a fixed dose of 5 mg/kg 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.
nab-P-SOX（nab-paclitaxel, oxaliplatin, S-1） (Drug)
A triplet chemotherapy backbone given on Day 1 of each 21-day cycle for 4 cycles: nab-paclitaxel 150 mg/m² IV, oxaliplatin 130 mg/m² IV, plus S-1 (tegafur/gimeracil/oteracil) 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.

Eligibility criteria

Inclusion Criteria: * Age 18-75 years * Histologically confirmed gastric or gastroesophageal junction adenocarcinoma, clinical stage cT3-4aN+M0 * Resectable disease, as determined by the surgical investigator * No prior radiotherapy, chemotherapy, or other systemic antitumor therapy * HER-2 negative * ECOG performance status 0-1 * Life expectancy greater than 6 months * Adequate organ function: hemoglobin \>= 90 g/L; absolute neutrophil count \>= 1.5 x 10\^9/L; platelet count \>= 100 x 10\^9/L; serum creatinine \<= 1.5 x ULN; ALT/AST \<= 2.5 x ULN; total bilirubin \<= 1.5 x ULN; amylase/lipase \< 1.5 x ULN; INR/APTT \<= 1.5 x ULN; urine protein \< 2+; LVEF \>= 50% * Women of childbearing potential must be non-pregnant, non-lactating, and agree to use adequate contraception * Provision of written informed consent and anticipated good compliance Exclusion Criteria: * Known allergy or hypersensitivity to the investigational drug(s) or excipients * History of other prior antitumor therapy * Therapeutic full-dose anticoagulation or thrombolysis within 10 days prior to first dose * Requirement for systemic corticosteroids or immunosuppressive therapy within 2 weeks prior to first dose * Active autoimmune disease or autoimmune disease with high risk of relapse * Within 6 months: gastrointestinal perforation, fistula, or obstruction; Crohn's disease or ulcerative colitis; or extensive intestinal resection * Symptomatic and uncontrolled brain or leptomeningeal metastases * History of interstitial lung disease/pneumonitis or pulmonary hypertension * History of organ transplantation * Uncontrolled hypertension (\>150/100 mmHg), diabetes mellitus, or cardiac arrhythmia * Arterial or venous thrombotic/embolic event within 6 months * Within 12 months: myocardial infarction, unstable angina, or NYHA class III/IV heart failure * Drainage of ascites, pleural effusion, or pericardial effusion within 4 weeks prior to enrollment * Non-healing wound, active ulcer, or untreated fracture * Other active malignancy * Active HIV, HBV, or HCV infection * Major surgery within 4 weeks prior to first dose * Any condition that, in the investigator's judgment renders the patient unsuitable for study participation

Conditions

Gastric Adenocarcinoma

Locations

Shanghai Jiaotong Univeristy School of Medicine Affiliated Ruijin Hospital — Shanghai, Shanghai Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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