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A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer
Sponsor: China Medical University, China
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-04-02
Completion Date
2027-11-30
Last Updated
2024-02-29
Healthy Volunteers
No
Conditions
Interventions
BioTTT001 intraperitoneal infusion
Monotherapy lead-in phase: BioTTT01 1×10\^10 VP, i.p., D1 and D3; Combination therapy phase: BioTTT01 1×10\^10 VP, i.p., D1 and D3, 3 weeks per cycle
SOX regimen
Combination therapy phase: Oxaliplatin 130 mg,i.v., D1 and D3, 3 weeks per cycle; Tegafur 40\~60mg b.i.d. p.o. D1\~D14; 3 weeks per cycle
toripalimab
Combination therapy phase: toripalimab 160mg i.v. D1, 3 weeks per cycle.