Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02785146
• Other study ID #: zsly Huaier-1
• Status: Recruiting
• Phase: Phase 3
• First received: May 19, 2016
• Last updated: June 7, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiaojian Wu, Ph.D.
• Phone: +86-13760608396
• Email: wuxjian[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Huaier Granule
Huaier Granule is continuously taken three times per day, 20g per time.
• Oxaliplatin
85 mg/m², ivdrip, D1
• Calcium folinate
Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
• 5-fluorouracil
400 mg/m², iv, D1; and 2400mg/m², civ, 48h

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University	Qidong Gaitianli Medicines Co., Ltd

Country where clinical trial is conducted

China, 

References & Publications (4)

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 — View 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. — View 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. — View 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/ß-catenin pathway. Oncol Lett. 2013 Apr;5(4):1171-1176. Epub 2013 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The effects of Huaier Granule on adverse events of adjuvant chemotherapy.	The adverse events were evaluated every 2 weeks; Eastern Cooperative Oncology Group(ECOG) scores, imaging assessment and related biochemical indicators.	6 months	Yes
Primary	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.	1 year	Yes
Secondary	Overall survival (OS)	OS was defined as the date of definitive surgery until the date of death or the last follow-up.	5 years	Yes
Secondary	Relapse-free survival (RFS)	RFS was defined as the date of definitive surgery until the date of recurrence or death from any cause.	5 years	Yes
Secondary	Metastasis-free survival (MFS)	MFS was defined as the date of definitive surgery until the date of metastasis or death from any cause.	5 years	Yes