Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery

Sixth Affiliated Hospital, Sun Yat-sen University230 enrolled

Overview

A randomized, paralleled control clinical study investigating Huaier Granule for prevention of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the efficacy and safety.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Colorectal Cancer

Interventions

Huaier GranuleDRUG

Huaier Granule is continuously taken three times per day, 20g per time.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subjects volunteer to sign the informed consent; * Aged: 18 to 75 years old; * Colorectal cancer (AJCC-TNM, Stage Ⅰ, low-risk Stage Ⅱand Stage Ⅲ; Patients with Stage Ⅲ colorectal cancer refuse to postoperative adjuvant chemotherapy); * The diagnosis and colorectal cancer has been confirmed by pathological examination after radical surgery; * The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT), alkaline phosphatase (ALP)\< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN; normal coagulation function; * Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): white blood cells count ≥ 3.0×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L; * ECOG：0-2 points； * No other previous history of malignancy. Exclusion Criteria: * Multiple primary cancer; * Not recover from the colorectal surgery; * Presence of organ, bone, or skin metastases; * Pregnant or lactating women; * Those with active bleeding due to various reasons; * Those with HIV infection or AIDS-associated diseases; * Those with severe acute and chronic diseases; * Those with severe diabetes; * Those with serious infectious diseases; * Those who can not take drugs by oral route; * Drug abusers or those with psychological or mental diseases that may interfere with study compliance; * Conditions that are considered not suitable for this study investigators.

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Disease-free survival (DFS)

DFS was defined as the date of definitive surgery until the date of recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.

Time frame: 1 year

Secondary Outcomes

Overall survival (OS)

OS was defined as the date of definitive surgery until the date of death or the last follow-up.

Time frame: 5 years

Relapse-free survival (RFS)

RFS was defined as the date of definitive surgery until the date of recurrence or death from any cause.

Time frame: 5 years

Metastasis-free survival (MFS)

MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause.

Time frame: 5 years

Central Contacts

Xiaojian Wu, Ph.D.

CONTACT

+86-13760608396 wuxjian@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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