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AzTrials

Colorectal CancerPhase 4NCT06090994

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

A Phase 4 study testing Huaier granule and Capecitabine in people with Colorectal Cancer, run by Fudan University at 9 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Huaier granule and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
756 participants
Where
9 sitesChina
Study dates
18 Oct 2024to Nov 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
  • Inability to take orally medication (experimental group, control group with oral medication included in standard treatment plan).
  • Pregnant or lactating women or planned pregnancy preparation.
  • 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).
  • Refusal to cooperate with follow-up.
  • Other reasons leading to the researcher's belief that it is not suitable to participate in this study.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sanjun Cai, PhD contact

+8618121299134

Fangqi Liu, PhD contact

+8613917902221

9 sites in 1 country

China9 sites, 9 recruiting

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213000

    Qicheng Lu, PhD, +8613915087018

    Not yet recruiting

  • Zhejiang Cancer Hospita

    Hangzhou, Zhejiang, 310005

    Haixing Jv, PhD, +8613858184823

    Qian Zhang, PhD, +8613588296045

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Binbin Cui, PhD, +8613351112888

    Not yet recruiting

  • Jiangsu People's Hospital

    Nanjing, Jiangsu, 210029

    Yueming Sun, PhD, +8613505188397

    Recruiting

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315046

    Wei Cui, PhD, +8613506842539

    Not yet recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Ren H Zhao, PhD, +8613918805942

    Recruiting

  • Sanjun Cai

    Shanghai, Shanghai Municipality, 200032

    Sanjun Cai, +8618121299134

    Recruiting

  • Renji Hospital，Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

    Zhe Cui, PhD, +8613512177595

    Not yet recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

    Daorong Wang, PhD, +8618051062590

    Recruiting

Other trials in China

About this study

Official title: 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

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

Read the detailed description

It is expected to include 756 patients with colorectal cancer (CRC) who were diagnosed as stage II and underwent radical resection (R0) according to the CSCO colorectal cancer guidelines 2022 and met the criteria for cabetabine monotherapy in the study center from July 2024 to June 2026. The experimental group was treated with Huaier Granule monotherapy, and 378 patients were expected to be included; The control group was treated with capecitabine monotherapy, and 378 cases were expected to be included. Patients in the experimental group began using Huaier granules within 14 days-2 months after surgery. Patients in control group received capecitabine treatment, with one course of treatment every 3 weeks, for a total of 4-6 courses. Patients will be visited every 12 weeks (± 14 days) for the first two years after enrollment, and every 24 weeks (± 14 days) for the third year, until the end of the study, withdrawal from the study for any reason, or death, whichever occurs first.

Being tested
Huaier granule, Capecitabine
Keywords
Huaier granule, colorectal cancer, capecitabine, recurrence and metastasis
Medical subject headings
Colorectal Neoplasms, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Huaier granuleDrug

    Also called Z20000109（NMPA Approval Number）

    Oral administration, 10g once, 3 times a day, starting within 14 days-2 months after surgery. Please refer to the medication manual for specific usage.

  • CapecitabineDrug

    Oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d),day 1-14,with one course of treatment every 3 weeks, for a total of 4-6 courses.

Study groups in NCT06090994
Study groupRoleWhat they receive
Huaier GranuleExperimentalOral administration of Huai'er granules, 10g once, 3 times a day, continued until the end of the study, intolerable toxicity, withdrawal from the study for any reason, disease progression or death, whichever occurs first; Or the researcher determines that the subject no longer benefits. It is recommended that Huai'er Granules be used for the first time within 14 days-2 months after surgery. Please refer to the drug instructions for specific usage.
Receives: Drug: Huaier granule
CapecitabineActive comparatorOral administration, 1250mg/m^2, twice a day (2500mg/m^2/d),day 1-14,with one course of treatment every 3 weeks，please refer to the drug instructions for specific usage.
Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year disease-free survival rate (DFS)

    The proportion of surviving patients who did not experience disease recurrence or metastasis within 3 years after R0 surgery.

    Measured: start of treatment until 3-year follow-up

Secondary outcomes (6)

  1. 1-year disease-free survival rate (DFS)

    The proportion of surviving patients who did not experience disease recurrence or metastasis within 1 years after R0 surgery.

    Measured: start of treatment until 1-year follow-up

  2. 2-year disease-free survival rate (DFS)

    The proportion of surviving patients who did not experience disease recurrence or metastasis within 2 years after R0 surgery.

    Measured: start of treatment until 2-year follow-up

  3. Overall survival (OS)

    The time from randomization and enrollment on the day of the patient to death for any reason.

    Measured: start of treatment until 3-year follow-up

  4. Quality of Life Score

    Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.

    Measured: baseline period and start of treatment until 3-year follow-up

  5. The incidence and severity of adverse events (AE) and severe adverse events (SAE)

    The definition and severity grading of AE and SAE refer to the corresponding descriptions in the definition and evaluation section of adverse events, and the incidence rate is defined as the proportion of patients with AE and SAE to the corresponding total population.

    Measured: start of treatment until 3-year follow-up

  6. The incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)

    The definition and severity grading of ADR, severe ADR, and SUSAR refer to the corresponding descriptions in the definition and evaluation section of adverse events. The incidence rate is defined as the proportion of patients with ADR, severe ADR, and SUSAR to the corresponding total population.

    Measured: start of treatment until 3-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2023
  2. Study start18 Oct 2024
  3. Primary completionJul 2027 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
756 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06090994
Sponsor's protocol ID
HE-202401
Status last verified
May 2025
First submitted
15 Oct 2023
Last updated
7 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Huaier granule and Capecitabine in people with Colorectal Cancer, run by Fudan University at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sanjun Cai, PhD (+8618121299134), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year disease-free survival rate (DFS) (time frame: start of treatment until 3-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06090994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.

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