OncoMatch/Clinical Trials/NCT04278222
Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)
Is NCT04278222 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Anlotinib Plus Toripalimab for gastric cancer.
Treatment: Anlotinib Plus Toripalimab — This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Gastric Cancer
Biomarker criteria
Excluded: HER2 (ERBB2) positive
harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive
Excluded: MMR deficient
dMMR/MSI-H
Excluded: MSI high
dMMR/MSI-H
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 2–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anlotinib
have received anlotinib
Cannot have received: immune checkpoint inhibitor
have received...other immune checkpoint inhibitor
Lab requirements
Blood counts
HB ≥ 90g/L, ANC ≥ 1.5 × 10^9/L, PLT ≥ 80 × 10^9/L
Kidney function
Serum Cr ≤ 1.5 × ULN
Liver function
BIL <1.5x ULN, ALT and AST <2.5x ULN; if liver metastases, BIL <3x ULN, ALT and AST <5x ULN
the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN), ALT and AST <2.5 × ULN and if liver metastases, BIL < 3 × ULN, ALT and AST <5 × ULN; Serum Cr ≤ 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04278222 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with ERBB2 alterations eligible?
No. ERBB2 positive is an exclusion criterion.
Are patients with MMR alterations eligible?
No. MMR deficient is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages