Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer

NCT05187481 | Unknown Phase 3

• 1 other identifier: CI2021A01803
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Neoplasms

Keywords

colorectal cancer; traditional Chinese medicine

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  From enrollment until disease progression or death

  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

• Overall survival

  From enrollment until death or end of the follow-up

  From date of randomization until the date of death from any cause, assessed up to 100 months

Secondary Outcomes (6)

• Survival rate

  3 years

• Disease control rate

  3 months

• Cancer fatigue score

  3 months

• Traditional Chinese Medicine(TCM )symptom grading table

  3 months

• The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale

  3 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will take Jianpi Huatan dispensing granule while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.

Drug: Jianpi Huatan dispensing granule

Control Group

PLACEBO COMPARATOR

The experimental group will take Placebo granule (containing 1/10 of the formula dose of Jianpi Huatan Granule) while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.

Drug: Placebo granule

Interventions

Jianpi Huatan dispensing granule DRUG

once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.

Experimental Group

Placebo granule DRUG

once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
• TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
• Expected survival time is over 3 months.
• The age of 18 years old or more.
• According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
• Chemotherapy and/or targeted therapy are planned.
• Signed informed consent.

You may not qualify if:

• History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
• Combined with severe heart, liver, lung and kidney disease.
• Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
• Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
• The expected survival time is less than 3 months.
• The researchers determine that they were not suitable for the study.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead
• China Academy of Chinese Medical Sciences: collaborator
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: collaborator

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yu Wu, Master

  Xiyuan Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

Central Study Contacts

Yu Wu, Master

CONTACT

010-62835438; zoujianhua2021@163.com

Jianhua Zou, Doctor

CONTACT

18810209092; 490943558@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: November 15, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 11, 2022

Record last verified: 2021-11

Locations

CN (1)