Clinical trial · Interventional
Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer
A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorogenic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chlorogenic acid, Treatment, powder
- description
- 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%.
- interventionNames
- Drug: Chlorogenic acid
Primary outcomes (1)
- measure
- disease control rate(DCR)
- timeFrame
- Within the first 10 weeks after the first dose of chlorogenic acid for injection
Secondary outcomes (4)
- measure
- objective response rate (ORR)
- timeFrame
- Within the first 10 weeks after the first dose of chlorogenic acid for injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18; 2. Recurrent small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC; 3. Estimated lifetime ≥ 3 months; 4. 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; 5. Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months; 6. Volunteered for the phase 1 trial and sign the informed consent without protest. Exclusion Criteria: 1. 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.; 2. Patients with brain metastases; 3. Patients with bone metastases; 4. Patients who have primary immunodeficiency; 5. Organ transplanters recipients; 6. Patients who have received the therapy of chemotherapy within 4 weeks or radical radiotherapy with in 6 weeks before enrollment; 7. Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan; 8. Patients who had received a therapy of another investigational drug within 1 month; 9. Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody; 10. Patients who have received therapy of major surgery within 6 weeks or biopsy surgery within 2 weeks before enrollment; 11. Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters; 12. Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment; 13. Patients who or have received radical radiotherapy within 6 weeks or local palliative radiotherapy within 2 weeks before enrollment; 14. History of drug abuse; 15. Patients who was treated with Immunologic drugs in 3 months; 16. Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).
References
Publications (1)
- DERIVEDZhu 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. PMID 40614321