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NOT YET RECRUITING
NCT06283121
PHASE2

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

Sponsor: China Medical University, China

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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

DRUG

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

DRUG

toripalimab

Combination therapy phase: toripalimab 160mg i.v. D1, 3 weeks per cycle.