CancerPhase 3NCT03940053
Prevention of Cancer Development and Progression
A Phase 3 study testing Arginine hydrochloride in people with Cancer, run by Zujiang YU.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of arginine in preventing cancer development Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Arginine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2019to 10 May 2025
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Ages 40-75 years 2. 2 ULN of tumor markers (CEA, AFP, ca-125, ca19-9, NSE, HCG and cyfra21-1) 3. No space-occupying lesions were found by the current imaging examination 4. The major organ function is normal that is meeting the following standards: Blood routine examination: (No blood transfusion, no G-CSF and no medication were corrected within 14 days before screening) a.HB≥80g/L； b.ANC≥1.5×109/L；c.PLT≥50×109/L; Biochemical examination: (ALB was not transfused within 14 days before screening) a. ALB ≥29 g/L； b.ALT and AST<5ULN；c. TBIL ≤3ULN；d.creatinine ≤1.5ULN( albumin and bilirubin, two indicators of Child-Pugh liver function class, can only have one for 2 points) 5. For women of childbearing age, the results of serum/urine pregnancy tests must be negative within 7 days before initiation of treatment. All men and women who participate in the study have to take reliable contraceptive measures within the trial and eight weeks after the trial is completed 6. volunteers must signed informed consent.
Who cannot join
- 1. patients suffering from any malignant tumors in the past (within 5 years) or at the same time; excluding cured basal cell carcinoma and carcinoma in situs of cervix 2. Patients who are undergoing transplantation or have a history of organ transplantation 3. Patients with an allergic history of arginine hydrochloride 4. The blood pressure cannot be reduced to the normal range by the antihypertensive drug treatment in patients with hypertension(systolic pressure>140 mmHg, diastolic pressure>90 mmHg) 5. Patients with myocardial ischemia or myocardial infarction over grade II or a poorly controlled arrhythmia (including QTc interval: men ≥450 ms; women ≥470 ms) 6.Cardiac functional insufficiency of grade III to IV according to NYHA standard; echocardiography: LVEF<50% 7. Patients with severe organ damage and less than 3 years expected survival time 8. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives 9. Patients with mental sickness or the history of psychotropic drug abuse 10. Patients with severe infection (unable to control the infection effectively) 11. The researchers believe that any other factors unsuitable for entering into the study.
About this study
Official title: The Efficacy of Arginine in Preventing Cancers. A Single Center, Open, Prospective Study
The purpose of this study is to evaluate the efficacy and safety of arginine in preventing cancer development
Read the detailed description
Cancer is considered to be the leading cause of death among non-infectious diseases and the most important obstacle to increase life expectancy for every country in the 21st century. However, even if various interventions such as embolization chemotherapy, systemic chemotherapy, radiofrequency ablation, and targeted therapy are widely used in clinical practice, the improvement of patients' survival is still limited. Our previous study found that arginine hydrochloride could significantly promote the apoptosis of liver cancer cells, and inhibit the progression of HCC by prompting the urea cycle. Therefore, our research group has carried out this study to evaluate the efficacy of arginine in preventing cancers.
- Conditions
- Cancer
- Being tested
- Arginine hydrochloride
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine hydrochlorideDrug
Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days. Treatment is continued until the levels of tumor marker dropped to normal
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Subjects only accept the routine treatment for underlying diseases. |
| Intervention | Experimental | Based on the routine treatment for underlying diseases, subjects were administrated by arginine. Receives: Drug: Arginine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
the percentage of patients with cancer from start of treatment to follow-up date of last participant cancers Incidence
Measured: 60 months
Secondary outcomes (2)
tumor markers
the levels of tumor markers in every check point
Measured: 60 months
Chinese Quality of Life Questionnaire - EORTC QLQ-C30 score
The overall enjoyment of life
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start10 May 2019 (estimated)
- Primary completion10 Aug 2024 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zujiang YU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zujiang YU, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940053
- Sponsor's protocol ID
- APT-001
- Status last verified
- May 2019
- First submitted
- 5 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Arginine in Preventing Cancers. A Single Center, Open, Prospective Study
- ClinicalTrials.gov ID
- NCT03940053
- Acronym / sponsor ID
- APT-001
- Conditions
- Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zujiang YUUniversity, hospital or other
- Study start
- 10 May 2019 (estimated)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 7 May 2019 (actual)
- 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.
The purpose of this study is to evaluate the efficacy and safety of arginine in preventing cancer development
Detailed description
Cancer is considered to be the leading cause of death among non-infectious diseases and the most important obstacle to increase life expectancy for every country in the 21st century. However, even if various interventions such as embolization chemotherapy, systemic chemotherapy, radiofrequency ablation, and targeted therapy are widely used in clinical practice, the improvement of patients' survival is still limited. Our previous study found that arginine hydrochloride could significantly promote the apoptosis of liver cancer cells, and inhibit the progression of HCC by prompting the urea cycle. Therefore, our research group has carried out this study to evaluate the efficacy of arginine in preventing cancers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –Subjects only accept the routine treatment for underlying diseases. |
| Intervention | Experimental | Drug: Arginine hydrochlorideBased on the routine treatment for underlying diseases, subjects were administrated by arginine. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Ages 40-75 years 2. 2 ULN of tumor markers (CEA, AFP, ca-125, ca19-9, NSE, HCG and cyfra21-1) 3. No space-occupying lesions were found by the current imaging examination 4. The major organ function is normal that is meeting the following standards: Blood routine examination: (No blood transfusion, no G-CSF and no medication were corrected within 14 days before screening) a.HB≥80g/L； b.ANC≥1.5×109/L；c.PLT≥50×109/L; Biochemical examination: (ALB was not transfused within 14 days before screening) a. ALB ≥29 g/L； b.ALT and AST<5ULN；c. TBIL ≤3ULN；d.creatinine ≤1.5ULN( albumin and bilirubin, two indicators of Child-Pugh liver function class, can only have one for 2 points) 5. For women of childbearing age, the results of serum/urine pregnancy tests must be negative within 7 days before initiation of treatment. All men and women who participate in the study have to take reliable contraceptive measures within the trial and eight weeks after the trial is completed 6. volunteers must signed informed consent.
Key exclusion criteria (1 listed)
- 1. patients suffering from any malignant tumors in the past (within 5 years) or at the same time; excluding cured basal cell carcinoma and carcinoma in situs of cervix 2. Patients who are undergoing transplantation or have a history of organ transplantation 3. Patients with an allergic history of arginine hydrochloride 4. The blood pressure cannot be reduced to the normal range by the antihypertensive drug treatment in patients with hypertension(systolic pressure>140 mmHg, diastolic pressure>90 mmHg) 5. Patients with myocardial ischemia or myocardial infarction over grade II or a poorly controlled arrhythmia (including QTc interval: men ≥450 ms; women ≥470 ms) 6.Cardiac functional insufficiency of grade III to IV according to NYHA standard; echocardiography: LVEF<50% 7. Patients with severe organ damage and less than 3 years expected survival time 8. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives 9. Patients with mental sickness or the history of psychotropic drug abuse 10. Patients with severe infection (unable to control the infection effectively) 11. The researchers believe that any other factors unsuitable for entering into the study.
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 |
|---|---|---|
| Arginine hydrochlorideArginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days. Treatment is continued until the levels of tumor marker dropped to normal | Drug | Intervention |
Primary outcome
Incidence
Time frame: 60 months
the percentage of patients with cancer from start of treatment to follow-up date of last participant cancers Incidence
2 secondary outcomes
tumor markers
Time frame: 60 months
Chinese Quality of Life Questionnaire - EORTC QLQ-C30 score
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arginine hydrochloride in people with Cancer, run by Zujiang YU.
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 1 inclusion and 1 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2019.