Neoadjuvant Iparomlimab and Tuvonralimab With Nab-P-SOX in Locally Advanced Gastric or Gastroesophageal Junction Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat
- •Potwierdzony histologicznie rak żołądka lub połączenia przełyku ze żołądkiem, stadium cT3-4aN+M0
- •Guz można operacyjnie usunąć
- •Brak wcześniejszej chemioterapii, radioterapii lub innych leków przeciwnowotworowych
- •Brak dodatniego markera HER-2
- •Dobry stan ogólny pacjenta (ECOG 0-1)
- •Spodziewana długość życia powyżej 6 miesięcy
- •Prawidłowe funkcje narządów (wątroba, nerki, serce, krew)
✗ Disqualifies
- •Alergia na badane leki lub ich składniki
- •Wcześniejsze leczenie przeciwnowotworowe
- •Przyjmowanie leków rozrzedzających krew w ciągu 10 dni przed badaniem
- •Przyjmowanie kortykosteroidów lub leków osłabiających odporność w ciągu 2 tygodni
- •Aktywna choroba autoimmunologiczna lub duże ryzyko jej powrotu
- •Perforacja lub niedrożność jelit, choroba Crohna lub wrzodziejące zapalenie jelita grubego w ciągu ostatnich 6 miesięcy
- •Przerzuty do mózgu ze symptomami
- •Historia choroby płuc lub przeszczepienia narządu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- October 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Shanghai Jiaotong Univeristy School of Medicine Affiliated Ruijin Hospital
Shanghai, China
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/10/2026.
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