XCHT for Irinotecan-Induced Gut Toxicities (Run-in Study)

NACompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 16, 2021

Primary Completion Date

July 20, 2024

Study Completion Date

July 20, 2024

Conditions
Malignant TumorDiarrhea
Interventions
DRUG

Xiao Chai Hu Tang (XCHT)

"XCHT 9g, po qd, 3 days before each cycle of chemotherapy for 5 days, except the 1st cycle of chemotherapy for irinotecan used cohort patients.~Additional XCHT, 9g qd will be orally administrated for 4 days during the Round 0 study for irinotecan naive cohort patients."

OTHER

Raloxifene

Raloxifene 60mg po, used as probe for pharmacokinetic testing. For irinotecan naive cohort patients, raloxifene 60mg will be orally administrated on Day 1 and Day 5 (4th day of XCHT administration) during round 0 study, Day 3 (the day before chemotherapy) during round 2 and round 3 study. For irinotecan used cohort patients, raloxifene 60mg will be orally administrated on Day 1 (irinotecan using day) during round 1 study, Day 4 (irinotecan using day) during round 2 study, and Day 3 (the day before chemotherapy) during round 3 study.

DRUG

FOLFIRI regimen

Patients will receive 3 cycles of FOLFIRI regimen for chemotherapy. Irinotecan intravenous (IV) infusion (180 mg/m2) through a drip into the bloodstream over 90 minutes. Folinic acid (400 mg/m2) IV infusion through a drip into the bloodstream over 2 hours. 5-fluorouracil (5-FU) IV bolus (400 mg/m2) into the bloodstream over 5 minutes, followed by 5-FU (2400 mg/m2) continuous IV infusion through a drip or pump into the bloodstream for 46-48 hours.

Trial Locations (1)

510120

Guangdong Provincial Hospital of Chinese Medicine, Guangzhou

All Listed Sponsors
collaborator

University of Houston

OTHER

lead

Guangzhou University of Traditional Chinese Medicine

OTHER

NCT04926545 - XCHT for Irinotecan-Induced Gut Toxicities (Run-in Study) | Biotech Hunter | Biotech Hunter