To evaluate the Safety and Efficacy of HIPEC Combined With Sintilimab for Gastric Cancer Patients with Peritoneal Metastasis.
Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
Age 18-75 years, Male or Non pregnant female
ECOG (Eastern Cooperative Oncology Group) : 0~1；
Negative for HER-2 by IHC/FISH；
Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.);
Previous systemic therapy for gastric cancer;
Recurrent gastric cancer after surgery;
Cardiopulmonary dysfunction;
Single group
HIPEC,anti-PD-1 antibody Sintilimab (Tyvyt®), Chemotherapy,Surgery
Drug1. HIPEC: HIPEC is performed after laparoscopic exploration, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgical exploration. 2. Chemotherapy(SOX) and anti-PD-1 antibody Sintilimab (Tyvyt®) treatment followed (4 cycles): SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid, po, day 1-14, every 3 weeks for a total of 4 cycles; Sintilimab (Tyvyt®) 200mg fixed dose every 3 weeks, for a total of 4 cycles. 3. Surgery: Imaging and secondary surgical exploration, assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases). For patients undergoing surgery, HIPEC for three cycles followed, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgery; For inoperable patients, continue to use standard chemotherapy of guidelines recommend. 4. After the surgery, continue to use standard adjuvant chemotherapy.
R0 resection
the rate of R0 resection
Overall survival time
Overall survival time(OS) refers to the time of first use of the drug to the time of death. At the end of the study, if the subject is still alive, refer the known "date of last survival of the subject" as the date of censoring.
ORR
Objective response rate(ORR): ORR = (number of subjects with complete response (CR) + partial response (PR))/total number of subjects ×100%. Measurable lesion according to the RECISTv1.1
Event-Free Survival
Defined as the interval between the first conversion therapy and the first recorded related events, including preoperative disease progression, postoperative disease recurrence, and death from any cause.
Relapse-Free Survival
Defined as postoperative the first recorded postoperative recurrence of disease or death from any cause
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
