Efficacy Evaluation of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer and Analysis of Dominant Population Characteristics and Methylation Characteristics

NCT05187481 Phase 3 UNKNOWN

This study will take progression-free survival and overall survival as the main evaluation indexes, to evaluate the Efficacy of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer. Decision Trees and Discriminant Analysis will be used to analyze the characteristics of dominant population combined with clinical data of patients. DNA methylation of the subjects will be detected to study the methylation characteristics of the preponderant population of Jianpi Huatan Decoction.

Details

Lead sponsor	Xiyuan Hospital of China Academy of Chinese Medical Sciences
Phase	Phase 3
Status	UNKNOWN
Enrolment	200
Start date	2021-11-15
Completion	2024-07

Conditions

• Colorectal Neoplasms

Interventions

• Jianpi Huatan dispensing granule
• Placebo granule

Primary outcomes

• Progression-free survival — From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
  From enrollment until disease progression or death
• Overall survival — From date of randomization until the date of death from any cause, assessed up to 100 months
  From enrollment until death or end of the follow-up

Countries

China