Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer

Study Overview
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Brief Summary
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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
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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）.

Official Title
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A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients

Conditions
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Advanced Lung Cancer

Intervention / Treatment
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* Drug: Chlorogenic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorogenic acid, Treatment, powder<br>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%. | Drug: Chlorogenic acid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate（DCR) |  | Within the first 10 weeks after the first dose of chlorogenic acid for injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate (ORR) |  | Within the first 10 weeks after the first dose of chlorogenic acid for injection | 
| progress free survival(PFS) |  | Within the first 10 weeks after the first dose of chlorogenic acid for injection | 
| Overall Survival（OS） |  | Within the first 10 weeks after the first dose of chlorogenic acid for injection | 
| Eastern Cooperative Oncology Group （ECOG） score standard |  | Within the first 10 weeks after the first dose of chlorogenic acid for injection |