Advanced Lung CancerPhase 1/2NCT03751592
Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer
A Phase 1/2 study testing Chlorogenic acid in people with Advanced Lung Cancer, run by Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd at 1 site in China.
Trial summary
This Ib / IIa clinical trial program focuses on the small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC in order to start a better development on the broad-spectrum value of chlorogenic acid： Determine the Disease control rate（DCR）of phase Ib/IIa of Chlorogenic acid for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung 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
- 144 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2018to 30 Apr 2021
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18;
- Recurrent small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC;
- Estimated lifetime ≥ 3 months；
- Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:1)PLT count≥80×10~9/L； 2)NEUT# count≥1.5×10~9/L ；3)HGB count≥90g/L；4)Total bilirubin <=1.5 times of ULN；5)ALT/AST ≤2.5 times of ULN；
- 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 suffer from other serious complication, such as uncontrollable infection, myocardial infarction within the past 6 months at the enrollment , uncontrollable hypertension ,thromboembolism and etc.;
- Patients with brain metastases;
- Patients with bone metastases;
- Patients who have primary immunodeficiency;
- Organ transplanters recipients;
- Patients who have received the therapy of chemotherapy within 4 weeks or radical radiotherapy with in 6 weeks before enrollment;
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- 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 1 month；
- Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;
- Patients who have received therapy of major surgery within 6 weeks or biopsy surgery within 2 weeks before enrollment;
- Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters；
- Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment;
- Patients who or have received radical radiotherapy within 6 weeks or local palliative radiotherapy within 2 weeks before enrollment;
- History of drug abuse；
- Patients who was treated with Immunologic drugs in 3 months;
- 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, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
Yuankai Shi, Dr
About this study
Official title: A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients
This Ib / IIa clinical trial program focuses on the small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC in order to start a better development on the broad-spectrum value of chlorogenic acid： Determine the Disease control rate（DCR）of phase Ib/IIa of Chlorogenic acid for injection in the advanced Lung Cancer Patients.
Read the detailed description
- Determine the Disease control rate（DCR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine the Overall Survival（OS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine the Objective response rate（ORR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine the Progression Free Survival（PFS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine Eastern Cooperative Oncology Group（ECOG）.
- Conditions
- Advanced Lung 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 group | Role | What they receive |
|---|---|---|
| Chlorogenic acid, Treatment, powder | Experimental | Chlorogenic 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.
disease control rate（DCR)
Measured: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Secondary outcomes (4)
objective response rate (ORR)
Measured: Within the first 10 weeks after the first dose of chlorogenic acid for injection
progress free survival(PFS)
Measured: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Overall Survival（OS）
Measured: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Eastern Cooperative Oncology Group （ECOG） score standard
Measured: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start17 Jul 2018
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Lung 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Dr, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751592
- Sponsor's protocol ID
- LYS-LC-01
- Status last verified
- Sep 2018
- First submitted
- 19 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT03751592
- Acronym / sponsor ID
- LYS-LC-01
- Conditions
- Advanced Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Sichuan J.Z. Bio-chemical Science and Technology Development Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 23 Nov 2018 (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.
This Ib / IIa clinical trial program focuses on the small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC in order to start a better development on the broad-spectrum value of chlorogenic acid： Determine the Disease control rate（DCR）of phase Ib/IIa of Chlorogenic acid for injection in the advanced Lung Cancer Patients.
Detailed description
- Determine the Disease control rate（DCR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine the Overall Survival（OS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine the Objective response rate（ORR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine the Progression Free Survival（PFS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
- Determine Eastern Cooperative Oncology Group（ECOG）.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chlorogenic acid, Treatment, powder | Experimental | Drug: Chlorogenic acidChlorogenic 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%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18;
- Recurrent small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC;
- Estimated lifetime ≥ 3 months；
- Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:1)PLT count≥80×10~9/L； 2)NEUT# count≥1.5×10~9/L ；3)HGB count≥90g/L；4)Total bilirubin <=1.5 times of ULN；5)ALT/AST ≤2.5 times of ULN；
- Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months;
Key exclusion criteria (16 listed)
- 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.;
- Patients with brain metastases;
- Patients with bone metastases;
- Patients who have primary immunodeficiency;
- Organ transplanters recipients;
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 |
|---|---|---|
| Chlorogenic acidChlorogenic 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. | Drug | Chlorogenic acid, Treatment, powder |
Primary outcome
disease control rate（DCR)
Time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
4 secondary outcomes
objective response rate (ORR)
Time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
progress free survival(PFS)
Time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Overall Survival（OS）
Time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Eastern Cooperative Oncology Group （ECOG） score standard
Time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Derived from this study: PubMed 40614321Zhu 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.
- Individual participant dataSharing planned: No
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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.
Yuankai Shi, Dr principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chlorogenic acid in people with Advanced Lung 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 6 inclusion and 16 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 26 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sheng Yang, Dr (8613683260156, medart@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease control rate（DCR) (time frame: Within the first 10 weeks after the first dose of chlorogenic acid for injection). 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 NCT03751592, 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 26 Nov 2018.