Prevention of Postoperative Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Standard Treatment

• Status: Not yet recruiting
• Trial end date: 2028-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective, multicenter, and exploratory study aimed at evaluating the effectiveness of Huaier Granules in preventing postoperative recurrence and metastasis of colorectal cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

Criteria

Inclusion Criteria:

• Age ≥ 18 years old, regardless of gender.

• It is diagnosed as colorectal cancer by histopathology, TNM stage ⅡC or Ⅲ.

• Previously underwent radical resection of colorectal cancer with a postoperative evaluation of R0.

• Prior to surgery, the patient did not receive other anti-tumor treatment and was judged by a doctor to be unsuitable for radiotherapy and chemotherapy (meeting any of the following criteria: ① those who are allergic to chemotherapy drugs and excipients; ② the patient has severe heart, liver, kidney and other dysfunction or serious cardiovascular disease; ③ the patient is extremely thin, dehydrated, in poor nutritional status, or in a cachexia state; ④ the patient's bone marrow hematopoietic function is inhibited, and white blood cells are less than 2×10^9/L or platelets < 50×10^9/L or severe anemia; ⑤ Concomitant severe infection; ⑥ Other contraindications to radiotherapy and chemotherapy determined by doctors or patients refusing to assist with radiotherapy and chemotherapy，patients in the control group plan to receive standard treatment after surgery.

• ECOG score 0-2 points.

• Agree to receive Huaier Granule treatment after enrollment (only in the experimental group).

• Conscious, capable of language expression or reading, able to communicate normally, and cooperate in completing questionnaire evaluations.

• Volunteer to join this study and sign an informed consent form.

Exclusion Criteria:

• History of merging with other malignant tumors.

• Known to be allergic to the components of Huai Er 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, Kang'ai 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.