Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
Investigational drug(s) / intervention(s)
SHR-1701CapecitabineS-1PaclitaxelOxaliplatin
SHR-1701: SHR-1701, 1800mg, Q3w
Capecitabine: Capecitabine, Q3W
S-1: S-1, Q3W
Paclitaxel: Paclitaxel,Q3W
Oxaliplatin: Oxaliplatin, Q3W
Study summary
This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years old.
2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion).
3. Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian metastasis is permitted), and without gastric outlet obstruction or intestinal obstruction.
4. No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
6. Normal function of major organs.
Exclusion Criteria:
1. Known HER2-positive.
2. Previous history of gastric cancer surgery.
3. Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.
4. Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).
5. Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease.
6. Significant cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction.
Primary outcome measure(s)
2-year overall survival rate — Up to 2 years
Trial sites (2)
Facility
City
Region
Status
Changhai Hospital
Shanghai
Shanghai Municipality
Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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