Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
Conditions
Brief 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.
Interventions
DRUGSHR-1701
SHR-1701, 1800mg, Q3w
DRUGCapecitabine
Capecitabine, Q3W
DRUGS-1
S-1, Q3W
DRUGPaclitaxel
Paclitaxel,Q3W
DRUGOxaliplatin
Oxaliplatin, Q3W
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate | Up to 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion surgery rate | Up to 4 weeks after completion of surgery | — |
| R0 resection rate | Up to 4 weeks after completion of surgery | — |
| Pathological complete response(pCR) | Up to 4 weeks after completion of surgery | — |
| Tumor regression grade | Up to 4 weeks after completion of surgery | — |
| Event free survival (EFS) | Up to 2 years | — |
| DFS | Up to 2 years | Disease-free survival (DFS) |
| Overall survival(OS) | Up to 3 years | — |
| AEs | Up to 3 years | — |
Countries
China
Contacts
CONTACTYanan Zheng
PRINCIPAL_INVESTIGATORYanan Zheng
Ruijin Hospital
Outcome results
None listed