A Phase 2 interventional study of Iparomlimab and Tuvonralimab (QL1706) and nab-P-SOX（nab-paclitaxel, oxaliplatin, S-1） in Gastric Adenocarcinoma, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
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.
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/PD-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/GEJ adenocarcinoma.
Study 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).
Objectives 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.
Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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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: Iparomlimab and tuvonralimab: 5 mg/kg by intravenous (IV) infusion; Nab-paclitaxel (albumin-bound paclitaxel): 150 mg/m² IV; Oxaliplatin: 130 mg/m² IV; S-1 (tegafur/gimeracil/oteracil): oral, twice daily on Days 1-14, with dose by body-surface area (\<1.25 m²: 40 mg/dose; 1.25-1.5 m²: 50 mg/dose; \>1.5 m²: 60 mg/dose). Curative-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.
Drug: Iparomlimab and Tuvonralimab (QL1706) · Drug: nab-P-SOX（nab-paclitaxel, oxaliplatin, S-1）
Drug page: Iparomlimab/Tuvonralimab
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.
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.
Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Baseline through pre-surgical restaging (after 4 neoadjuvant cycles of 21 days each; approximately 12 weeks from first dose)
Disease Control Rate (DCR), Defined as Complete Response + Partial Response + Stable Disease per RECIST v1.1
Time frame: Baseline through pre-surgical restaging (after 4 neoadjuvant cycles of 21 days each; approximately 12 weeks from first dose)
Plan to share: No — The investigators decide not to share.
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Started Feb 2025 (actual). Primary completion is estimated for Dec 2026, 22 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Iparomlimab/Tuvonralimab