Dynamic change of gut microbiome and metabolite, and its effects on immune modulation in locally advanced rectal cancer

Efficacy and safety of GEN-001 plus total neoadjuvant therapy and dynamic change of gut microbiome in locally advanced rectal cancer: exploratory, pilot, prospective, longitudinal study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006662

Enrollment

Registered

2021-10-12

Start date

2021-12-15

Completion date

Unknown

Last updated

2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : GEN-001 is Lactococcus lactis (L. lactis), anaerobic gram-positive microbiome, and each capsule contains 1x1011/CFU of L. lactis. GEN-001 is orally administered once daily in the morning with w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age > 19 years 2. Locally advanced rectal cancer, histologically confirmed; clinically T3/4, clinically N+, enlarged lateral lymph nodes, extramural vascular invasion (+), or mesorectal fascia (+) 3. Patients who schedule to receive total neoadjuvant therapy, including short-course radiotherapy (25 Gy in 5 fractions), followed by FOLFOX chemotherapy (5-fluorouracil, leucovorin, and oxaliplatin) 4. Patients with ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities tha may alter absoprtion 5. Patients with ability to collect their blood and stool samples

Exclusion criteria

Exclusion criteria: 1. Rectal cancer, other histologic type than adenocarcinoma (such as squamous cell carcinoma) 2. Patients who schedule to receive concurrent chemoradiotherapy or short-course radiotherapy alone followed by surgery and adjuvant chemotherapy 3. Patients who need emergent surgery or colostomy due to obstruction or bleeding 4. Prior use of proton pump inhibitors or H2 blockers, probiotics, immunosuppressive agents, and antibiotics within 4 weeks 5. Patients have concurrent medication that may interact with fluoropyrimidine or oxaliplatin (i.e. flucytosine, phenytoin, or warfarin) 6. Known prior history of severe adverse events during fluoropyrimidine or deficiency of dihydropyrimidine dehydrogenase (DPD) 7. Known prior severe hypersensitivity to platinum 8. Patients have an active infection requiring antibiotics, antifungal, or antiviral agents 9. Prior solid organ or allogenic stem cell transplantation 10. Patients who underwent major surgery within 4 weeks or did not recover from complications 11. Patients have clinically significant medical disease : cardiovascular disease 160 mmHg or diastolic blood pressure > 100 mmHg : serious cardiac arrhythmia requiring medication 12. Pregnant women 13. Patients have psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements

Design outcomes

Primary

Measure	Time frame
Dynamic change of gut microbiome and metabolite	—

Secondary

Measure	Time frame
Effects of TNT plus GEN-001 on immune modulation ;Efficacy and safety of TNT with GEN-001;Predictive biomarkers for pathologic response	—

Countries

Korea, Republic of

Contacts

Public ContactJwa Hoon Kim

Korea University Anam Hospital

jhoonkim@korea.ac.kr+82-2-2199-3804

Outcome results