Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Ade… (NCT06932068) | Clinical Trial Compass
RecruitingPhase 2
Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma
China77 participantsStarted 2025-03-26
Plain-language summary
This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 18-75 years, gender is not limited;
✓. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
✓. HER2-negative by immunohistochemistry (IHC);
✓. low PD-L1 expression status (CPS \< 5);
✓. Has at least 1 measurable lesion as determined by RECIST 1.1;
✓. No systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
✓. Adequate organ function;
Exclusion criteria
✕. Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
✕. Cardiovascular and cerebrovascular events that are not well controlled;
✕. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks;
✕. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
What they're measuring
1
progression-free survival (PFS)
Timeframe: 12 months after the last subject participating in
✕. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;
✕. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;
✕. Brain metastasis or leptomeningeal metastasis;
✕. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;