Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Infections

Rare Diseases

Neoplasm Metastasis

Stomach Neoplasms

Virus Diseases

Adenoviridae Infections

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Tegafur

Oxaliplatin

Interleukin-12

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 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.

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

BioTTT001 intraperitoneal infusion

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

SOX regimen

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

toripalimab

Shuhui Song, bachelor

Zhenning Wang, MD

Funan Liu, MD

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.

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

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

Objective response rate (ORR) as assessed by the investigators

The time from the start of treatment to progress disease or death for any cause

The time from the start of treatment to death for any cause

Beijing Bio-Targeting Therapeutics Technology Co., Ltd

China Medical University, China

professor

Micronutrients

Amino Acids

Capecitabine

Leucovorin

Fluorouracil

Taurine

Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX

Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX

Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.

Sintilimab

XELOX regimen

Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)

FOLFOX regimen

Xiaodi Zhao, MD, PhD

Xin Wang, MD, PhD

Jia Yu, MD

Yuanyuan Lu, MD, PhD

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone.

Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer

A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer

Changes in number, apoptosis rate, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of CD8+ T cells in peripheral venous blood assessed via flow cytometry.

Changes in number, effector (TNF-α, IFN-γ, etc.) production and immune checkpoint molecule (PD-1, CTLA-4, etc.) expression of tumor-infiltrating CD8+ T cells in gastric cancer endoscopic biopsy material assessed via immunohistochemistry.

PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on independent radiology review or death due to any cause, whichever occurs first.

OS was defined as the time from randomization to death due to any cause.

ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer	NCT06283121	Gastric Cancer,...	BioTTT001 intra... SOX regimen toripalimab	18 Years -	China Medical University, China
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer	NCT06123455	Gastric Cancer	Taurine Sintilimab XELOX regimen SOX regimen FOLFOX regimen	18 Years -	Tang-Du Hospital
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer	NCT06123455	Gastric Cancer	Taurine Sintilimab XELOX regimen SOX regimen FOLFOX regimen	18 Years -	Tang-Du Hospital

Spots Global Cancer Trial Database for sox regimen

Every month we try and update this database with for sox regimen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sox regimen

Every month we try and update this database with for sox regimen cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sox regimen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.