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A Phase II Clinical Trial of PD-L1 Expression-Based Epaploitovorilimab Combined with Chemotherapy as First-Line Treatment for Metastatic Gastric Cancer: Single-Arm, Open-Label

A Phase II Clinical Trial of PD-L1 Expression-Based Epaploitovorilimab Combined with Chemotherapy as First-Line Treatment for Metastatic Gastric Cancer: Single-Arm, Open-Label

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115675
Enrollment
Unknown
Registered
2025-12-30
Start date
2025-12-30
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

Research group:Aipalolitovorili 5mg/kg, Tegio 40mg/m^2, Oxaliplatin 130mg/m^2

Sponsors

The First Affiliated Hospital of Bengbu Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Clinically confirmed metastatic gastric cancer or gastroesophageal junction adenocarcinoma; 2. ECOG PS score =1; 3. At least one measurable lesion (RECIST 1.1 criteria); 4. Adequate bone marrow reserve and good organ function; 5. Age 18-70 years; 6. Male or non-pregnant, non-lactating female; 7. Expected survival over 6 months; 8. Disease stabilization or progression after first-line guideline-recommended therapy.

Exclusion criteria

Exclusion criteria: 1. Received other radiotherapy, chemotherapy, targeted therapy, or immunotherapy within the past 4 weeks; 2. Presence of autoimmune diseases; 3. Require the use of immunosuppressants; 4. Concurrent other malignant tumors; 5. Severe impairment of liver and kidney function, cardiopulmonary function, or coagulation disorders, or presence of severe underlying diseases that cannot tolerate chemotherapy; 6. Severe mental illness or uncontrolled infectious diseases; 7. ECOG performance status score > 2; 8. Other clinical or laboratory conditions deemed by the investigator as unsuitable for the patient to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate (ORR);

Secondary

MeasureTime frame
Disease Control Rate (DCR);Progression-Free Survival (PFS);Overall Survival (OS);Safety;

Countries

China

Contacts

Public ContactYangang Zhang

The First Affiliated Hospital of Bengbu Medical University

michaelhww@zju.edu.cn+86 156 4232 8327

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026