Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients undergoing laparoscopic surgery using ArtiSential

ArtiSential

Jung Wook Huh, MD PhD

Dae HEe Pyo, MD PhD

Sun Wha Kim

Dae Hee Pyo, MD, PhD

Jung Wook Huh, MD, PhD

This study is to validate the safety and feasibility of ArtiSential (Articulating laparoscopic instrument) colorectal surgery and compare it with robotic surgery for patients with rectal cancer and rectosigmoid junction cancer.

A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry

conversion, postoperative complications, or less than 12 harvested lymph nodes

Total medical cost during hospital stay for surgery

Asan Medical Center

Seoul St. Mary's Hospital

Chonnam National University Hospital

Severance Hospital

Seoul National University Bundang Hospital

Uijeongbu St. Mary Hospital

LivsMed

Samsung Medical Center

Professor

Sigmoid Neoplasms

Colonic Neoplasms

Sigmoid Diseases

Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels.

One capsule QD oral administration for 28 days

GB104(Level 1)

Three capsules QD oral administration for 28 days

GB104(Level 2)

Five capsules QD oral administration for 28 days

GB104(Level 3)

Sujin Kim, Ph.D.

Woo Yong Lee, M.D., Ph.D.

Dae Hee Pyo, M.D., Ph.D.

Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial

This is a single center, open-label, phase 1 study to evaluate the safety and tolerability of GB104 and explore gut microbial composition in patients with colorectal cancer who completed standard treatment including curative colectomy with or without full-cycle adjuvant chemotherapy. GB104 is a live biotherapeutic product consisting of a lyophilized formulation of a single strain of bacterium. The dosing regimen for the study involves the oral administration of the experimental drug once a day.

Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

Open-label, Single-center, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety and Tolerability of GB104, and Explore Gut Microbial Composition in Patients Who Completed Curative Colectomy and Planned Therapy of Colorectal Cancer

analyzed by 16S rRNA gene amplicon sequencing

* Immune response activation factors(cytokine)
* Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry

analyzed by EQ-5D-5L(EuroQoL 5-Dimensions 5-Level) questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry	NCT05566249	Rectal Cancer Rectosigmoid Ca... Rectosigmoid Ju...	ArtiSential	18 Years - 80 Years	Samsung Medical Center
Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer	NCT05943041	Solid Tumor Colorectal Canc... Sigmoid Colon C... Rectosigmoid Ju... Cancer Rectal Cancer	GB104(Level 1) GB104(Level 2) GB104(Level 3)	19 Years -	GI Biome, Inc.
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry	NCT05566249	Rectal Cancer Rectosigmoid Ca... Rectosigmoid Ju...	ArtiSential	18 Years - 80 Years	Samsung Medical Center

Spots Global Cancer Trial Database for rectosigmoid junction cancer