gastric cancer with peritoneal metastasis
Conditions
Interventions
Experimental group:tislelizumab combined with intraperitoneal and intravenous Nab-Paclitaxel plus S-1 oral chemotherapy
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The eligibility criteria of this study are as follows: (1) Primary HER2 negative GC or gastroesophageal junction cancer that is pathologically diagnosed as adenocarcinoma; (2) Patients who have received no prior chemotherapy, radiotherapy or other anti-tumor therapy,or who have received less than two months of prior chemotherapy; (3) Age 18 years to 75 years, male or non-pregnant, non-lactating female patients; (4) ECOG score 0-1 points; (5) Gastric cancer peritoneal metastasis needs to be diagnosed by imging examination or laparoscopy; (6) Patients who cannot tolerate or reject HIPEC; (7) According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at lease one lesion that can be measured by imaging, which has not received prior radiothehrapy or other topical treatments; (8) Adequate organ function within the first 7 days before the first administation, including: ? Normal bone marrow function (neutrophils = 1.5 × 109/L, hemoglobin = 90 g/L, platelets = 80 × 109/L); ? Normal liver and kidney functions (total bilirubin = 1.5 × upper limit of normal (ULN), ALT and AST = 2.5 × ULN, serum creatinine of = 1.5 × ULN, creatinine clearance of > 50 ml/min); (9) Expected lifetime = 12 weeks; (10) Sign the informed consent.
Exclusion criteria
Exclusion criteria: Patients will be not enrolled in this study if one of the following exlusiion criteria are met: (1) Confirmed evidence of distant metastasis other than peritoneal metastasis (e.g., liver metastasis, lung metastasis, brain or bone metastasis); (2) Patients who have received more than two months of prior chemotherapy; (3) Diagnosed with malignant diseases other than GC within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); (4) Patients with serious or uncontrolled complications such as cardiovascular disease, myocardial infarction, diabetes mellitus or recurrent infections; (5) Patients are currently treated with anti-cancer drugs from other clinical trials; (6) Other factors that may affect the safety or test compliance of the subjects according to the judgment of the researchers; (7) Patients with a history of hypersensitivity to Nab-Paclitaxel or any drugs ingredient; (8) Patients for whom systemic immunosuppressive therapy was used 14 days before the first administration, excluding local or physiological doses of systemic glucocorticoids (e.g., no more than 10 mg/day of prednisone or other glucocorticoids of equivalent dose); (9) Patients who have active autoimmune disease or a history of refractory autoimmune disease; subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (e.g., vitiligo, psoriasis or alopecia) can be selected; (10) Patients who refuse to provide blood/tissue samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median overall survival (mOS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;median progression-free survival;the side-effect profile;Health-related quality of life; | — |
Countries
China
Contacts
Public ContactXianzi Yang
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Outcome results
None listed