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

• Status: Unknown status
• Trial end date: 2021-04-30
• Target enrollment: 0
• Participant gender: All

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 injection in the advanced Lung Cancer Patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
• Collaborator: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Criteria

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).