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

NCT06283121 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-29

No results posted yet for this study

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.

Conditions

  • Gastric Cancer, Metastatic

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.

Sponsors & Collaborators

  • Beijing Bio-Targeting Therapeutics Technology Co., Ltd

    collaborator INDUSTRY

  • China Medical University, China

    lead OTHER

Principal Investigators

  • Zhenning Wang, MD · The First Affiliated Hospital of China Medical Univeristy

  • Funan Liu, MD · The First Affiliated Hospital of China Medical Univeristy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2027-11-30
Completion
2027-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283121 on ClinicalTrials.gov