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

NCT02785146 | Unknown Phase 3 DMC

• 1 other identifier: zsly Huaier-1
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Huaier Granule; After radical surgery; Prevention of recurrence and metastasis; Efficacy and safety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Overall survival (OS)

  5 years

• Relapse-free survival (RFS)

  5 years

• Metastasis-free survival (MFS)

  5 years

Other Outcomes (1)

• The effects of Huaier Granule on adverse events of adjuvant chemotherapy.

  6 months

Study Arms (2)

mFOLFOX6 + Huaier Granule

EXPERIMENTAL

Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ). Huaier Granule will be administrated from the first cycle of chemotherapy until 48 weeks after surgery or until study termination. Huaier Granule is continuously taken three times per day, 20g per time.

Drug: Huaier Granule; Drug: Oxaliplatin; Drug: Calcium folinate; Drug: 5-fluorouracil

mFOLFOX6

ACTIVE COMPARATOR

Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ).

Drug: Oxaliplatin; Drug: Calcium folinate; Drug: 5-fluorouracil

Interventions

Huaier Granule DRUG

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

Also known as: Huaier

mFOLFOX6 + Huaier Granule

Oxaliplatin DRUG

85 mg/m², ivdrip, D1

mFOLFOX6; mFOLFOX6 + Huaier Granule

Calcium folinate DRUG

Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1

Also known as: Calcium levofolinate

mFOLFOX6; mFOLFOX6 + Huaier Granule

5-fluorouracil DRUG

400 mg/m², iv, D1; and 2400mg/m², civ, 48h

mFOLFOX6; mFOLFOX6 + Huaier Granule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Qidong Gaitianli Medicines Co., Ltd: collaborator

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 20718753 RESULT

• 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.

  PMID: 22895629 RESULT

• 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.

  PMID: 23599758 RESULT

• 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.

  PMID: 25077927 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

huaier; Oxaliplatin; Leucovorin; Fluorouracil

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xiaojian Wu, Ph.D.

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojian Wu, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 27, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 8, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)