OncoMatch/Clinical Trials/NCT06468280
Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer
Is NCT06468280 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including PD-1 Monoclonal Antibody and XELOX/SOX Chemotherapy Regimen for gastric cancer.
Treatment: PD-1 Monoclonal Antibody · XELOX/SOX Chemotherapy Regimen · Trastuzumab · Zolbetuximab — ROSETTE trial is an open-label, randomized phase II study designed to investigate treatment strategies for patients with limited metastatic gastric or gastroesophageal adenocarcinoma. Eligible patients are randomized to receive either systemic treatment followed by surgeon-led local treatment, or systemic treatment alone. Systemic treatment combines immunotherapy with chemotherapy, with or without targeted therapy, while the surgeon-led local treatment utilizes a surgery-centric, multi-modality approach involving resection of both primary and metastatic tumors where feasible. For unresected or unresectable metastatic lesions, alternative local therapies are provided. The primary endpoint is the 1-year event-free survival (EFS) rate. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), extended EFS, overall survival (OS), pathologic complete response rate (pCR), major pathologic response rate (MPR), and R0 resection rate.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: PD-L1 (CD274) expression status known (status known)
known PD-L1 expression status
Required: MMR proficient mismatch repair (proficient)
proficient mismatch repair (pMMR)
Required: MSI microsatellite stability (stable)
microsatellite stability (MSS)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cytotoxic chemotherapy
Previous cytotoxic chemotherapy
Cannot have received: radiotherapy
Previous radiotherapy
Cannot have received: immunotherapy
Previous immunotherapy
Cannot have received: curative surgery
Previous curative surgery
Cannot have received: anti-PD-1 therapy
Prior PD-1/PD-L1/PD-L2 or other T-cell-targeting therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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