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Advanced CancerPhase 1NCT02245204

Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers

A Phase 1 study testing Chlorogenic acid in people with Advanced Cancer, run by Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study: Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the advanced malignant tumor subjects; Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Advanced Cancer
What is being tested?
Chlorogenic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
Sep 2014to Oct 2016
Phase
Phase 1
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with pathologic or/and FNAC confirmation of advanced cancer but without effective treatment or with treatment failure;
  • Between 18 and 65 years of age, KPS≥70;
  • According to RECIST 1.1,patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as >2.0cm by general CT or >1.0cm by spiral CT;
  • Life expectancy of at least three (3) months at the enrollment;
  • Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:
  • PLT count≥100×10~9/L,
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  • WLB count≥4.0×10~9/L and ≤12×10~9/L,
  • Neutrophil granulocyte count≥2.0×10~9/L,
  • HGB count≥90g/L,
  • Total bilirubin <=1.5 times of ULN,
  • ALT/AST ≤2.5 times of ULN,
  • SCr≤1.5 times of ULN,
  • Normal ECG with LVEF (≥50%) measured by echocardiography;
  • Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months;
  • Volunteered for the phase 1 trial and sign the informed consent without protest;

Who cannot join

  • Patients who have received large area radiotherapy （>30% marrow capacity）;
  • Patients who suffer from other serious complication, such as uncontrollable infection, myocardial infarction within the past 6 months at the enrollment , uncontrollable hypertension ,thromboembolism and etc.;
  • Symptomatic patients with brain metastases (except for the patients whose brain metastases is controlled to stable status after whole brain radiotherapy);
  • Patients who have received the therapy of chemotherapy within 4 weeks before enrollment;
  • Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment;
  • Patients who have received therapy of major surgery within 6 weeks or biopsy surgery within 2 weeks before enrollment;
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  • Patients who or have received radical radiotherapy within 6 weeks or local palliative radiotherapy within 2 weeks before enrollment;
  • Patients who experience grade 2 or more than grade 2 toxicity caused by the past therapies;
  • Patients who have history of drug abuse or alcoholism;
  • Patients who smoke over 5 cigarettes or equivalent tobacco per day;
  • Uncontrollable psychopaths;
  • Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan;
  • Patients who had received a therapy of another investigational drug within 4 weeks or patients who are still in another clinical trial at the enrollment;
  • Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;
  • Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters;
  • Allergic to the investigational drug;
  • Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, 100142

Other trials in China

About this study

The purpose of this study:

Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the advanced malignant tumor subjects;

Read the detailed description
  1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for injection in the advanced malignant tumor subjects;
  2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection;
  3. Preliminary observation the effectiveness and effective dose;
  4. Provide the basis for the dosage regimen of phase II/III.
Conditions
Advanced Cancer
Being tested
Chlorogenic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chlorogenic acidDrug

    Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.

Study groups in NCT02245204
Study groupRoleWhat they receive
Chlorgenic acid, Treatment, powderExperimentalChlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.
Receives: Drug: Chlorogenic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events

    Measured: Within the first 60 days after the first dose of chlorogenic acid

Secondary outcomes (4)

  1. Dose-Limiting Toxicity

    Measured: Within the first 30 days after the first dose of chlorogenic acid

  2. Maximum Tolerated Dose

    Measured: Within the first 30 days after the first dose of chlorogenic acid

  3. Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid

    Measured: Within the first 30 days after the first dose of chlorogenic acid

  4. Improvement in cancer-related symptoms and quality of life

    Measured: Within 1 year after the first dose of chlorogenic acid

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02245204
Sponsor's protocol ID
LYS-I-01
Status last verified
Oct 2018
First submitted
16 Sep 2014
Last updated
21 Nov 2018
Results posted
No
Data monitoring committee
No

Publications

  • Zhu H, Chen J, Dong X, Qin X, Li Z. Influence of dihydrocaffeic acid and quinic acid on lung metabolism and function: Implications for dietary interventions. Biochem Biophys Res Commun. 2025 Sep 1;777:152274. doi: 10.1016/j.bbrc.2025.152274. Epub 2025 Jun 28.

    PubMed 40614321

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Chlorogenic acid in people with Advanced Cancer, run by Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd 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 15 inclusion and 17 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: finished, as of the sponsor's last update on 21 Nov 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of adverse events (time frame: Within the first 60 days after the first dose of chlorogenic acid). 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 NCT02245204, which also lists 1 linked publication.

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 21 Nov 2018.

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