Clinical Trials Logo

Clinical Trial Summary

In this phase 2 study, we combined sintilimab, paclitaxel and S-1 as regimen to treat gastric cancer patients with peritoneal metastasis. We are aim to estimate the efficacy and safety of this regimen in the phase 2 study.


Clinical Trial Description

Gastric cancer patients enrolled in this a phase 2 study received sintilimab (200mg intravenously on day 1), paclitaxel (PTX) (20 mg/m2 intraperitoneally and 50 mg/m2 intravenously on days 1 and 8) plus oral S-1 (80 mg/m2 for 14 consecutive days) every 3 weeks. The primary endpoint is 1-year survival rate. Secondary endpoints are adverse events, R0 resection rate, 3-year overall survival (OS), and 3-year progressive free survival. Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05204173
Study type Interventional
Source Ruijin Hospital
Contact Zhongyin Yang, PhD
Phone 8621-64370045
Email [email protected]
Status Recruiting
Phase Phase 2
Start date May 20, 2021
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03422432 - Prophylactic HIPEC for Colorectal Cancers at High Risk of Developing Peritoneal Metastases N/A
Not yet recruiting NCT05277766 - Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer Phase 1
Recruiting NCT05056389 - Normothermic Intraperitoneal Chemotherapy - Long Term in Peritoneal Metastases From Colorectal Cancer (NIPEC-OXA) Phase 1
Withdrawn NCT03682744 - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC) Phase 1
Not yet recruiting NCT05095467 - HIPEC-AS in Patients With Peritoneal Metastasis of the Stomach or Esophagogastric Junction Phase 2
Completed NCT04083547 - Circulating Tumour Cells in Patients With Peritoneal Metastases
Recruiting NCT05379790 - Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis of Gastric Origin Phase 1
Recruiting NCT04956068 - PIPAC for Peritoneal Metastases Phase 1
Not yet recruiting NCT05300945 - HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy Phase 2/Phase 3
Recruiting NCT04861558 - Efficacy of Hyperthermic Intraperitoneal Chemotherapy Phase 3
Recruiting NCT05340569 - Diagnostic Value of DWI-MRI for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma. N/A
Recruiting NCT03834272 - Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies N/A
Not yet recruiting NCT04744688 - Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment
Active, not recruiting NCT03733184 - Development of an IDEAL Framework to Standardise Cytoreductive Surgery for Colorectal Peritoneal Metastases
Recruiting NCT03757858 - Hyperthermia Combined With Immunotherapy in the Treatment of Abdominal and Pelvic Malignancies or Metastases Phase 1/Phase 2
Recruiting NCT03413254 - Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal Metastases Phase 3
Recruiting NCT04943653 - Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis Phase 1/Phase 2
Recruiting NCT05431907 - Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis Phase 1/Phase 2
Recruiting NCT02172690 - Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients N/A
Not yet recruiting NCT05353582 - Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases Phase 2