To Explore the Effect of Huaier Granule on the Negative Conversion Rate After the CEA Level Increases Again After Colorectal Cancer Surgery

NCT06665334 | Not Yet Recruiting Phase 4

• 1 other identifier: HE-202203
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a prospective, observational and exploratory study to explore the effect of Huaier Granule on the negative conversion rate of patients with increased CEA levels after colorectal cancer surgery.

Conditions

Colorectal Cancer

Keywords

Huaier Granule; Colorectal Cancer; CEA Level; Negative Conversion Rate

Outcome Measures

Primary Outcomes (1)

• Rate of CEA conversion to negative

  The proportion of patients whose CEA levels returned to normal at each visit to the total number of patients at that follow-up.

  start of treatment until 2-year follow-up

Secondary Outcomes (2)

• 1 or 2-year disease-free survival rate (DFS)

  start of treatment until 2-year follow-up

• Quality of Life Score

  baseline period and start of treatment until 2-year follow-up

Other Outcomes (1)

• The changes (rate values) of tumor markers (including but not limited to CA199, CA24-2, CA72-4, and CA50) compared to baseline

  start of treatment until 2-year follow-up

Study Arms (2)

Huaier Granule

EXPERIMENTAL

Oral administration of Huaier granule, 10g (1 bag) each time, 3 times a day, is recommended for at least 6 months until there is imaging progression of the disease, the end of the study, intolerable toxicity, withdrawal or death from the study for any reason, or the researcher determines that there is no longer benefit, whichever occurs first.

Drug: Huaier granule

Routine clinical treatment

NO INTERVENTION

During routine clinical follow-up, patients who underwent R0 resection were found to have abnormally elevated levels of CEA, and therefore no intervention was generally given. If there is imaging progress, intolerable toxicity, or withdrawal from the study for any reason during the research period (whichever occurs first), routine clinical treatment will be administered.

Interventions

Huaier granule DRUG

Oral administration, 10g per dose (1 bag), 3 times a day, recommended for at least 6 months.

Also known as: Z20000109#NMPA Approval Number#

Huaier Granule

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old, gender not limited
• Diagnosed with colorectal cancer through histopathology, pTNM stage I-III
• Previously underwent radical resection for colorectal cancer, with a postoperative evaluation of R0
• Imaging did not detect recurrence or distant metastasis
• Serum CEA\>5.2ng/ml within 1 year after surgery (found during routine clinical follow-up)
• Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation
• Voluntary participation in this study, good compliance, and signing of informed consent form.

You may not qualify if:

• Known to be allergic to the components of Huaier Granule, or to avoid or use Huaier Granule with caution (observation group)
• Cannot take medicine orally
• Have received anti-tumor traditional Chinese patent medicines and simple preparations treatment within 1 month before enrollment (subject to the instructions)
• Combining medical history of other malignant tumors
• Diabetes with serious heart, cerebrovascular and lung diseases, severe hypertension and poor blood sugar control
• Suffering from intestinal diverticulitis, rectal polyps, colitis, pancreatitis, cirrhosis, hepatitis, etc
• Currently participating in clinical trials of other drugs
• Pregnant or lactating women or those planning to conceive
• Refusing to cooperate with follow-up visits
• Other reasons led the investigators to believe that it was not suitable to participate in this study

Sponsors & Collaborators

• Fudan University: lead

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

• Ye Xu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Xu, PhD

CONTACT

+8613817171710; xu_shirley021@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 31, 2024

Record last verified: 2024-10