💬In plain words
What the trial is, and whether it could suit you
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 remov
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- Iparomlimab and Tuvonralimab (QL1706)
- nab-P-SOX(nab-paclitaxel, oxaliplatin, S-1)
Shanghai Jiaotong Univeristy School of Medicine Affiliated Ruijin Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.