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

Sichuan J.Z. Bio-chemical Science

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Advanced Lung Cancer

Treatments: Drug: Chlorogenic acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03751592

LYS-LC-01

Details and patient eligibility

About

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.

Full description

1. Determine the Disease control rate（DCR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
2. Determine the Overall Survival（OS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
3. Determine the Objective response rate（ORR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
4. Determine the Progression Free Survival（PFS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
5. Determine Eastern Cooperative Oncology Group（ECOG）.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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144 participants in 1 patient group

Chlorogenic acid, Treatment, powder

Experimental group

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%.

Treatment:

Drug: Chlorogenic acid