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Recruiting NCT03349762

Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery

— Observational Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery

Overview

To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery

Detailed description

This is a multisite, open-label, prospective study investigating Huaier Granule for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery，to evaluate the efficacy and safety.

Primary outcome measures

  • Disease-Free Survival(DFS) [Time frame: 36 months]
  • Overall survival(OS) [Time frame: 36 months]
  • Local recurrence-Free Survival rate [Time frame: 36 months]
  • Distant Metastasis-Free Survival rate [Time frame: 36 months]
Secondary outcome measures (4)
  • Change From Baseline in Quality of Life (QOL) [Time frame: 36 months]
  • Incidence rate of Adverse events (AE) [Time frame: 36 months]
  • Severity of Adverse events [Time frame: 36 months]
  • Immunity function [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

  • Males or females ages 18-75 years;
  • The first time to the therapy of patients who received the radical surgery within two months, Postoperative histopathology confirms the diagnosis of colorectal cancer with stage IIB, IIC and III ( TNM classification)
  • ECOG score of 0-2;
  • No history of malignant tumors;
  • The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.

Exclusion criteria

  • Patients have basic diseases including heart diseases, cerebrovascular disease, lung disease, severe hypertension or diabetes with poor glycemic control;
  • confirmed infections after surgery ;
  • Patients who have post-surgery complications or who are currently under the influence of the radical surgery for colorectal cancer;
  • Being infected with syphilis or with other blood-borne infectious diseases;
  • Pregnancy or lactation; or women of childbearing potential not using contraception;
  • Patients who have taken Traditional Chinese Medicines with efficacy and indications similar to that of Huaier granule - including, but not limited to, compound Banmao capsule., Huachansu capsule, Kangai Injection and Pingxiao tablets;
  • Patients who are suffering from mental illness or Conditions that are considered not suitable for this study investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 22 centers
  • The Fourth Hospital of Hebei Medical University — Shijiazhuang
  • The First Clinical Hospital affiliated to Harbin Medical University — Harbin
  • The Second Affiliated Hospital of Harbin Medical University — Harbin
  • Hubei Cancer Hospita — Wuhan
  • Union Hospital Tongji College Huazhong University of Science and Technology — Wuhan
  • Hunan Provincial People's Hospital — Changsha
  • Xiangya Hospital Central South University — Changsha
  • Changzhou No.2 People's Hospital — Changzhou
  • … and 14 more centers

Identifiers

NCT: NCT03349762 · HE-201709

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗