A Phase 2 interventional study of Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
A single-arm, Phase II clinical study protocol of Apatolimab Tovolimab in combination with regorafenib and chemotherapy as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma
The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Thrombotic events (arterial or venous) within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (excluding previously thrombosed veins deemed healed by the investigator), and pulmonary embolism.
8. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
9. Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.
Drug: Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy
Iparomlimab and Tuvonralimab:5mg/kg,Intravenous infusion,Q3W regorafenib:80mg,oral administration once daily from Day 1 to Day 14 chemotherapy:XELOX or SOX
Objective response rate
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DoR)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 5 years
The incidence and severity of adverse events (AE) during the study period (Safety)
The incidence and severity of adverse events (AE) during the study period
Time frame: Up to approximately 2 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University