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NCT Number: NCT03349762

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

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Disease-Free Survival(DFS)

    Time frame: 36 months

    Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death.

  2. Overall survival(OS)

    Time frame: 36 months

    OS was defined as the time from participation to death from any cause or last patient last visit.

  3. Local recurrence-Free Survival rate

    Time frame: 36 months

    The proportion of Local recurrence-Free Survival subjects to the total number of subjects.

  4. Distant Metastasis-Free Survival rate

    Time frame: 36 months

    The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.

Secondary outcomes

  1. Change From Baseline in Quality of Life (QOL)

    Time frame: 36 months

    Quality of Life (QOL) were measured using supplemental quality of life questions. Item score range（12 items）: 1 (worst symptom) to 5 (no symptom). Change: score at 36 months minus score at baseline.

  2. Incidence rate of Adverse events (AE)

    Time frame: 36 months

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  3. Severity of Adverse events

    Time frame: 36 months

    An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  4. Immunity function

    Time frame: 36 months

    Immunity function was measured with Immune cells counts and positive rate.

Study contacts

Contact information is provided by the study sponsor or research team.

Xishan Wang, Professor

CONTACT

[email protected]

+0086-13552367779

Sponsors and collaborators

Lead sponsor

Xi Shan Wang

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Nov 22, 2017
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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