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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
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
Combination therapy phase: toripalimab 160mg i.v. D1, 3 weeks per cycle.
Objective response rate (ORR)
Objective response rate (ORR) as assessed by the investigators
Time frame: Imaging was performed every 6 weeks during the combination therapy phase
Progression-free survival (PFS)
The time from the start of treatment to progress disease or death for any cause
Time frame: Every 6 weeks until disease progression, consent withdraw, death or end of study during the combination therapy phase, up to 100 weeks.
Overall survival (OS)
The time from the start of treatment to death for any cause
Time frame: Every 3 months until consent withdraw, death, withdrawal study, or loss of follow-up, up to 100 weeks
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