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Study identifier: NCT06468280 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer

Condition: Gastric Cancer · GastroEsophageal Cancer  ·  Sponsor: Shanghai Zhongshan Hospital

PhasePhase 2
Planned participants84
Who can joinAll sexes, 18 Years to 79 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Xuefei Wang, MD, PhD  ·  0  ·  wang.xuefei@zs-hospital.sh.cn

Always discuss trial participation with your own doctor first.

Locations (2)

Zhongshan Hospital Fudan UniversityShanghai, Shanghai City, ChinaNot Yet Recruiting
Zhongshan Hospital, Fudan UniversityShanghai, Shanghai Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06468280