OncoMatch/Clinical Trials/NCT06939452
A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression
Is NCT06939452 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies anlotinib +TQB2450 + Oxaliplatin+S-1 for advanced gastric or gastroesophageal junction (g/gej) adenocarcinoma.
Treatment: anlotinib +TQB2450 + Oxaliplatin+S-1 — To evaluate the efficacy and safety of anlotinib combined with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
HER2-negative (or HER2 status undetermined)
Required: PD-L1 (CD274) low expression (CPS <5) (CPS <5)
PD-L1 combined positive score (CPS) <5
Disease stage
Metastatic disease required
unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: (neo)adjuvant chemotherapy or radiotherapy — adjuvant/neoadjuvant
Disease recurrence >6 months after completion of (neo)adjuvant chemotherapy or radiotherapy
Cannot have received: anlotinib (anlotinib hydrochloride)
Prior treatment with anlotinib hydrochloride
Cannot have received: immune checkpoint inhibitor
any immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies)
Lab requirements
Blood counts
Hemoglobin (Hb): ≥ 90 g/L (no blood transfusion within 14 days); ANC: ≥ 1.5 × 10⁹/L; Platelet Count (PLT): ≥ 100 × 10⁹/L (no IL-11 or TPO within 14 days); WBC: ≥ 4.0 × 10⁹/L (no G-CSF within 14 days)
Kidney function
Serum Creatinine (Cr): ≤ 1.5 × ULN or CrCl ≥ 60 mL/min (Cockcroft-Gault)
Liver function
Total Bilirubin (TBIL): ≤ 1.5 × ULN; ALT & AST: ≤ 2.5 × ULN (≤ 5 × ULN with hepatic metastases); Serum Albumin: ≥ 25 g/L (2.5 g/dL)
Cardiac function
LVEF ≥ 50% (or above institutional lower limit of normal); NYHA Class III-IV heart failure or LVEF <50% excluded; Grade ≥2 myocardial ischemia, myocardial infarction, or arrhythmias (QTc ≥480 ms) excluded
Organ Function Requirements and Laboratory Test Criteria During Screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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 qualify