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NCT06090994RecruitingPhase 4

Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy

A Prospective, Multicenter, Randomized, Parallel Controlled Study Comparing Huaier Granules With Capecitabine Monotherapy for the Prevention of Recurrence and Metastasis After Radical Resection of Stage II Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 7 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a prospective, multicenter, randomized, parallel controlled study to evaluate the effectiveness of Huaier Granule in preventing recurrence and metastasis after radical resection of colorectal cancer

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
756 (estimated)
First submitted
15 Oct 2023
Start date
18 Oct 2024
Primary completion date
Jul 2027
Lead sponsor
Fudan University
NCT number
NCT06090994

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 756
  • From 18 Oct 2024 to the primary completion date, Jul 2027
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Inability to take orally medication (experimental group, control group with oral medication included in standard treatment plan).
  • In the past one month, the subjects have received Huaier granules or traditional Chinese patent medicines and simple preparations with similar efficacy or indications to Huaier granules (such as compound cantharides capsules, cinobufacin capsules, Kangai injection, Pingxiao tablets, please refer to the instruction manual for details).

Other illness

  • Low rectal cancer (occurring within 12 centimeters from the anal margin)
  • Combining medical history of other malignant tumors.
  • Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (only in the experimental group).

Other

  • Pregnant or lactating women or planned pregnancy preparation.
  • Refusal to cooperate with follow-up.
  • Other reasons leading to the researcher's belief that it is not suitable to participate in this study.

Who the study is looking for

  • Age ≥ 18 years old, regardless of gender.
  • It is diagnosed as colorectal cancer by histopathology, TNM stage Ⅱ.
  • Received radical resection of colorectal cancer (R0) within 12 weeks prior to enrollment.
  • Not receiving neoadjuvant therapy before surgery, and not receiving any adjuvant therapy after surgery.
  • ECOG score 0-2 points.
  • According to the CSCO Colorectal Cancer Guidelines 2022, it meets the criteria for receiving monotherapy adjuvant therapy with capecitabine.
  • Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate in completing questionnaire assessments.
  • Voluntarily join this study and sign an informed consent form.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First People's Hospital Of Changzhou
Coordinator of this site? Confirm its status
ChangzhouChinaNot yet recruiting
Zhejiang Cancer Hospita
Coordinator of this site? Confirm its status
HangzhouChinaNot yet recruiting
Harbin Medical University Cancer Hospital
Coordinator of this site? Confirm its status
HarbinChinaNot yet recruiting
Jiangsu People's Hospital
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Ningbo Medical Center Lihuili Hospital
Coordinator of this site? Confirm its status
NingboChinaNot yet recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaNot yet recruiting
Sanjun Cai
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Northern Jiangsu People's Hospital
Coordinator of this site? Confirm its status
YangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.