Advanced gastric cancer with malignant ascites
Conditions
Interventions
Experimental group:hyperthermic intraperitoneal chemotherapy combined with Tislelizumab
Control group:hyperthermic intraperitoneal chemotherapy combined with palliative chemotherapy
Sponsors
Changzhou No.2 People's Hospital of Jiangsu Province
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient must sign an informed consent form and must be willing and able to comply with the visits, treatment plans, laboratory tests and other requirements of the research schedule. 2. The age of the patients ranged from 18 to 70 years old, regardless of sex. 3. KPS score >= 50, ECOG physical strength score 0-1. 4. The estimated survival time is more than three months. 5. He had not received systemic chemotherapy or local radiotherapy for nearly one month, and had not been treated with PD1 inhibitors before. 6. Meet the diagnostic criteria of advanced gastric cancer with malignant ascites: moderate to massive ascites was confirmed by abdominal CT or B-ultrasound. 7. Never received intraperitoneal hyperthermic perfusion chemotherapy. 8. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: HB >=90 g/L, ANC >1.5 * 10^9/L; PLT > 100 * 10^9/L, TBIL < 1.5 times of upper limit of normal reference value, ALT and AST < 2.5 times of upper limit of normal reference value (Liver metastasis < 5 * ULN), and CRE < 1.2mg/dl. 9. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1. Extensive adhesion in the abdominal cavity caused by various reasons, and poor healing factors such as edema, ischemia, tension and so on existed in the anastomosis. 2. Previously exposed to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T cell costimulatory or checkpoint pathways. 3. At the same time, participate in another interventional clinical study, unless you participate in an observational (non-interventional) clinical study or are in the follow-up phase of an interventional study. 4. Patients who are known to be allergic to macromolecular protein preparations, or to any of the components of carrizumab (shr-1210) and its preparations 5. Immunosuppressive drugs were used within 4 weeks prior to the study, excluding nasal, inhaled or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., no more than 10mg/ prednisone or equivalent doses of other glucocorticoids), or the use of hormones for the prevention of contrast medium allergy. 6. Symptomatic central nervous system metastasis and / or cancerous meningitis are known. For previously treated patients with brain metastasis, if the patient's condition is stable (there is no evidence of imaging progress at least 4 weeks before the first administration of the trial treatment), repeated imaging examinations confirmed that there was no evidence of new brain metastasis or enlargement of the original brain metastasis, and no steroid treatment was needed at least 14 days before the first administration of the trial treatment, you can participate in the trial. This exception does not include cancerous meningitis and should be excluded regardless of whether its clinical condition is stable or not. 7. Patients with uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade II or above heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within one year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. 8. Patients with congenital or acquired immune deficiency (such as HIV infected patients), active hepatitis B (HBV-DNA >=104 copies / ml) or hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method) or active tuberculosis; 9. Patients with active infection or fever with unknown cause more than 38.5 degrees C within 2 weeks before randomization (according to the judgment of the researcher, the fever of the subject due to tumor can be included in group); 10. The fertile male or female is unwilling to take contraceptive measures in the test, and the female patient is pregnant or lactating; 11. According to the researcher's judgment, there are other factors that may cause him / her to be forced to terminate the study midway, such as other serious diseases (including mental diseases) requiring combined treatment, family or social factors, which may affect the safety of the subject or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor immune microenvironment;T cell subsets;ct-DNA;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR; | — |
Countries
China
Contacts
Public ContactJiang Hua
Changzhou No.2 People's Hospital of Jiangsu Province
Outcome results
None listed