Colorectal CancerPhase 3NCT02785146
Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer
A Phase 3 study testing Huaier Granule, Oxaliplatin and Calcium folinate in people with Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Huaier Granule, Oxaliplatin and Calcium folinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Xiaojian Wu, Ph.D., +86-13760608396, wuxjian@mail.sysu.edu.cn
About this study
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
- Being tested
- Huaier Granule, Oxaliplatin, Calcium folinate, 5-fluorouracil
- Keywords
- Huaier Granule, After radical surgery, Prevention of recurrence and metastasis, Efficacy and safety
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier GranuleDrug
Also called Huaier
Huaier Granule is continuously taken three times per day, 20g per time.
OxaliplatinDrug
85 mg/m², ivdrip, D1
Calcium folinateDrug
Also called Calcium levofolinate
Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
5-fluorouracilDrug
400 mg/m², iv, D1; and 2400mg/m², civ, 48h
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 ). Receives: Drug: Oxaliplatin; Drug: Calcium folinate; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Overall survival (OS)
OS was defined as the date of definitive surgery until the date of death or the last follow-up.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Qidong Gaitianli Medicines Co., Ltd
- Responsible party
- Principal investigator, Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Xiaojian Wu, Ph.D., Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785146
- Sponsor's protocol ID
- zsly Huaier-1
- Status last verified
- Jun 2016
- First submitted
- 19 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators would like to share the data to the Participating units.
Publications
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.
PubMed 20718753Wang 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.
PubMed 22895629Zhang 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.
PubMed 23599758Wang 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.
PubMed 25077927
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02785146
- Acronym / sponsor ID
- zsly Huaier-1
- Conditions
- Colorectal Cancer
- Keywords
- Huaier Granule, After radical surgery, Prevention of recurrence and metastasis, Efficacy and safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Qidong Gaitianli Medicines Co., Ltd
- Study start
- Jun 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX6 + Huaier Granule | Experimental | Drug: Huaier Granule, Drug: Oxaliplatin, Drug: Calcium folinate, Drug: 5-fluorouracilTwelve 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 | Drug: Oxaliplatin, Drug: Calcium folinate, Drug: 5-fluorouracilTwelve 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 ). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huaier GranuleAlso: HuaierHuaier Granule is continuously taken three times per day, 20g per time. | Drug | mFOLFOX6 + Huaier Granule |
| Oxaliplatin85 mg/m², ivdrip, D1 | Drug | mFOLFOX6, mFOLFOX6 + Huaier Granule |
| Calcium folinateAlso: Calcium levofolinateCalcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1 | Drug | mFOLFOX6, mFOLFOX6 + Huaier Granule |
| 5-fluorouracil400 mg/m², iv, D1; and 2400mg/m², civ, 48h | Drug | mFOLFOX6, mFOLFOX6 + Huaier Granule |
Primary outcome
Disease-free survival (DFS)
Time frame: 1 year
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.
3 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Relapse-free survival (RFS)
Time frame: 5 years
Metastasis-free survival (MFS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Results publication: PubMed 20718753Zhang 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.
- Results publication: PubMed 22895629Wang 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.
- Results publication: PubMed 23599758Zhang 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.
- Results publication: PubMed 25077927Wang 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.
- Individual participant dataSharing planned: Yes. The investigators would like to share the data to the Participating units.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojian Wu, Ph.D. principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Huaier Granule, Oxaliplatin and Calcium folinate in people with Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojian Wu, Ph.D. (+86-13760608396, wuxjian@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02785146, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.