Actively Recruiting
Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer
Led by Shanghai Zhongshan Hospital · Updated on 2026-01-21
84
Participants Needed
2
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18-79
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert II or III only) with known PD-L1 expression status
- Gastric cancer with proficient mismatch repair (pMMR) or microsatellite stability (MSS) as determined by immunohistochemistry or NCI-recommended microsatellite markers
- Resectable primary gastric cancer lesions with limited distant metastases meeting specified criteria
- No previous anti-tumor treatments
- ECOG score 642, no surgical contraindications
- Life expectancy of at least 3 months
- Physical condition and organ function suitable for major abdominal surgery
- Willingness and ability to comply with the study protocol
- Fertile women with negative pregnancy test and agreement to use effective contraception during study and for 180 days after last dose; non-sterilized men must also agree to use effective contraception
- Signed informed consent with understanding that patients can withdraw anytime
You will not qualify if you...
- Inability to tolerate oral chemotherapy
- Primary gastric lesion confined to mucosa or submucosa with isolated ovarian metastasis
- Central nervous system metastasis and/or carcinomatous meningitis
- Allergy to any components of study medication
- History of previous or concurrent malignancies except certain resected cancers with no recurrence for 5 years
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Weight loss of 20% or more within two months before enrollment
- Upper gastrointestinal obstruction or physiological dysfunction
- Previous cytotoxic chemotherapy, radiotherapy, immunotherapy, or curative surgery
- Prior PD-1/PD-L1/PD-L2 or other T-cell-targeting therapy
- Use of systemic steroids or immunosuppressants within 14 days before enrollment
- Live vaccine within four weeks prior to enrollment
- Uncontrolled systemic disease
- Active or past autoimmune diseases that may recur
- Severe chronic or active infections needing systemic treatment
- History of lung disease
- Pregnancy, lactation, or planning pregnancy
- HBsAg-positive with HBV DNA 650500 IU/mL
- Positive HIV antibody
- Conditions affecting study compliance or participation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Zhongshan Hospital Fudan University
Shanghai, Shanghai City, China, 200032
Not Yet Recruiting
2
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 201000
Actively Recruiting
Research Team
X
Xuefei Wang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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