Spots Global Cancer Trial Database for A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer

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Trial Identification

Brief Title: A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer

Official Title: A Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Combination With SOX and Toripalimab in Patients With Peritoneal Metastases From Gastric Cancer

Study ID: NCT06283121

Conditions

Gastric Cancer, Metastatic

Interventions

BioTTT001 intraperitoneal infusion

SOX regimen

toripalimab

Study Description

Brief 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.

Detailed 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.