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OncoMatch/Clinical Trials/NCT05494060

XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma

Is NCT05494060 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Anlotinib hydrochloride capsule and Penpulimab for carcinoma.

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT05494060Data as of May 2026

Treatment: Anlotinib hydrochloride capsule · Penpulimab · XELOXThis is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Disease stage

Required: Stage III

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: surgery — radical resection (D2, R0 or R1)

had been treated with Radical resection (D2, R0 or R1) of gastric cancer

Cannot have received: immune targeted therapy

Previous use of immune targeted therapy drugs

Lab requirements

Blood counts

Hemoglobin ≥90 g/L; Neutrophil count ≥1.5×10^9/L; Platelet count ≥100×10^9/L

Kidney function

Serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min

Liver function

Total bilirubin≤1.5×ULN; ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST ≤ 5×ULN

Cardiac function

No obvious clinical symptoms of heart disease

The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements: ... No obvious clinical symptoms of heart disease.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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