Phase Ⅱ Study of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a single-center, prospective, phase II clinical trial aimed at assessing the impact of HIPEC combined with systemic chemotherapy and immune checkpoint inhibitors on the R0 resection rate in patients with peritoneal metastasis from gastric cancer. Furthermore, it seeks to analyze the effects of this treatment strategy on overall survival (OS), progression-free survival (PFS), PCI and adverse reaction rates.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 18-75 years

• Men, or non-pregnant and non-lactating women

• Pathological diagnosis as gastric malignant tumor

• diagnosis of peritoneal metastasis \[peritoneal cancer index (PCI) ≤ 12 points\] by laparoscopic exploration

• Normal major organ function:

⁃ 1\) HB ≥ 90 g/L; ANC ≥ 1.5×109/L; plt ≥125×109/L; 2) TBIL\<1.5ULN; ALT, AST \<2.5ULN; Cr≤1.25ULN; ALB ≥ 30 g/L 6. Not receive radiation therapy, chemotherapy, targeted therapy, or immunotherapy.

⁃ 7\. Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1 8. Patients are volunteers, have signed informed consent, and agree to cooperate with investigators in data collection.

Locations
Other Locations
China
Wuhan Union Hospital
RECRUITING
Wuhan
Contact Information
Primary
Kaixiong Tao, PhD
taokaixiong@hust.edu.cn
13507155452
Backup
Yuping Yin, PhD
yinyuping2017@hust.edu.cn
15927412321
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 34
Treatments
Experimental: HIPEC combined with SOX and Tislelizumab
The participants volunteering to take HIPEC combined with SOX and immune checkpoint inhibitors will be assigned to this group.
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: BeiGene

This content was sourced from clinicaltrials.gov

Similar Clinical Trials