Clinical trial NCT02785146: Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer
Official title: Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Huaier Granule
After radical surgery
Prevention of recurrence and metastasis
Efficacy and safety
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Qidong Gaitianli Medicines Co., Ltd
First posted: 2016-05-27
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* The subjects volunteer to sign the informed consent
* Aged: 18 to 75 years old
* Colorectal cancer (AJCC-TNM, high-risk Stage II and Stage III)
* 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

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Relapse-free survival (RFS)
timeFrame: 5 years
measure: Metastasis-free survival (MFS)
timeFrame: 5 years
Other outcomes:
measure: The effects of Huaier Granule on adverse events of adjuvant chemotherapy.
timeFrame: 6 months
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Xiaojian Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang N, Kong X, Yan S, Yuan C, Yang Q. Huaier aqueous extract inhibits proliferation of breast cancer cells by inducing apoptosis. Cancer Sci. 2010 Nov;101(11):2375-83. doi: 10.1111/j.1349-7006.2010.01680.x.
citation: Wang X, Zhang N, Huo Q, Yang Q. Anti-angiogenic and antitumor activities of Huaier aqueous extract. Oncol Rep. 2012 Oct;28(4):1167-75. doi: 10.3892/or.2012.1961. Epub 2012 Aug 8.
citation: Zhang T, Wang K, Zhang J, Wang X, Chen Z, Ni C, Qiu F, Huang J. Huaier aqueous extract inhibits colorectal cancer stem cell growth partially via downregulation of the Wnt/beta-catenin pathway. Oncol Lett. 2013 Apr;5(4):1171-1176. doi: 10.3892/ol.2013.1145. Epub 2013 Jan 21.
citation: Wang X, Zhang N, Huo Q, Sun M, Dong L, Zhang Y, Xu G, Yang Q. Huaier aqueous extract inhibits stem-like characteristics of MCF7 breast cancer cells via inactivation of hedgehog pathway. Tumour Biol. 2014 Nov;35(11):10805-13. doi: 10.1007/s13277-014-2390-2. Epub 2014 Jul 31.