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Clinical Trial Summary

This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer.


Clinical Trial Description

This study intends to enroll Her2-negative subjects with first-line treatment of peritoneal metastasis from gastric cancer. Subjects will be treated with BioTTT001 intraperitoneal perfusion combined with SOX and toripalimab after completing the screening period, and the subjects will first receive BioTTT001 monotherapy treatment with BioTTT001 1×10^10 viral particle (VP) intraperitoneal perfusion (P.I.), D1 and D3, and enter the combination therapy stage 7 days (±1d) after the first dose of BioTTT001.Subjects will be treated with the regimen as follows: BioTTT001 injection, 1×10^10 VP P.I., D1;toripalimab 160mg intravenous (i.v.), D1; Oxaliplatin 130mg/m^2 i.v. , D1 ; Tegafur 40~60mg Bis in die(b.i.d.) Peroral(p.o.)D1~D14; 3 weeks per cycle. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06283121
Study type Interventional
Source China Medical University, China
Contact Shuhui Song, bachelor
Phone 15004240769
Email 593900927@qq.com
Status Not yet recruiting
Phase Phase 2
Start date April 2, 2024
Completion date November 30, 2027

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06427252 - The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of GC or EGJC With PM Phase 2
Not yet recruiting NCT02976142 - The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer Phase 2