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| Name | Class |
|---|---|
| Qidong Gaitianli Medicines Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 ). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaier Granule | Drug | Huaier Granule is continuously taken three times per day, 20g per time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS was defined as the date of definitive surgery until the date of death or the last follow-up. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojian Wu, Ph.D. | Contact | +86-13760608396 | wuxjian@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojian Wu, Ph.D. | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20718753 | Result | 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. | |
| 22895629 | 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. |
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The investigators would like to share the data to the Participating units.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000621679 | huaier |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
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| Oxaliplatin | Drug | 85 mg/m², ivdrip, D1 |
|
| Calcium folinate | Drug | Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1 |
|
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| 5-fluorouracil | Drug | 400 mg/m², iv, D1; and 2400mg/m², civ, 48h |
|
| 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. | 5 years |
| 23599758 | 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. |
| 25077927 | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005492 |
| Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |