Actively Recruiting
Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer
Led by Fudan University · Updated on 2025-09-26
30
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy of disitamab vedotin in combination with sintilimab and SOX as conversion therapy in patients with initially unresectable locally advanced or metastatic gastric cancer exhibiting HER2 IHC 1+/2+ expression. The trial plans to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ status. Participants will receive disitamab vedotin combined with sintilimab and SOX for 4 to 6 treatment cycles. Those who achieve successful conversion will undergo surgical resection, while patients with unsuccessful conversion will either continue the original regimen or switch to an alternative treatment at the investigator's discretion.
CONDITIONS
Official Title
Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily enrolled and provided written informed consent
- Aged 18 to 70 years (inclusive), male or female
- Histologically and/or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
- No prior systemic anticancer therapy
- HER2 immunohistochemistry (IHC) result of 2+ or 1+, confirmed by previous tests or central lab
- Presence of a single initial unresectable factor
- At least one measurable lesion per RECIST 1.1 criteria
- Life expectancy of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as defined by specific blood counts, liver and kidney function tests, and coagulation parameters within 14 days prior to screening
You will not qualify if you...
- History of other malignancies except those treated curatively with no disease for 5 years or certain in situ cancers
- Conditions affecting drug absorption, distribution, metabolism, or excretion such as severe vomiting or intestinal obstruction
- Previous allogeneic stem cell or solid organ transplantation
- Prior systemic antitumor therapy completed less than 4 weeks before study treatment or unresolved treatment-related adverse events greater than CTCAE grade 1 (except alopecia or pigmentation)
- History or presence of congenital or acquired immunodeficiency disorders
- Active or past autoimmune or inflammatory disorders, except certain resolved conditions or as approved by investigator
- Use of systemic immunosuppressive therapy within 2 weeks before enrollment or anticipated need during study, with some corticosteroid exceptions
- Known or suspected hypersensitivity to disitamab vedotin, anti-PD-1 agents, related antibodies, or excipients
- History of thrombotic or thromboembolic events within 6 months
- Significant bleeding risks including recent major bleeding, active bleeding, coagulation disorders, or current use of anticoagulant or antiplatelet therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200230
Actively Recruiting
Research Team
X
Xiaowen Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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