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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 (May 2026). This Phase 2 trial studies Anlotinib Plus Toripalimab for gastric cancer.

Phase 2RecruitingShanghai Changzheng HospitalNCT04278222Data as of May 2026

Treatment: Anlotinib Plus ToripalimabThis 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.

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Extracted eligibility criteria

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

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

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