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

NCT ID: NCT03751592

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2021-04-30

Brief 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.

Detailed 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）.

Conditions

Advanced Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chlorogenic acid, Treatment, powder

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%.

Group Type: EXPERIMENTAL

Chlorogenic acid

Intervention Type: DRUG

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.

Interventions

Chlorogenic acid

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.

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuankai Shi, Dr

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Sheng Yang, Dr

Role: CONTACT

medart@126.com

8613683260156

Jianping Xu, Dr

Role: CONTACT

13651379626@139.com

8613651379626

Other Identifiers

LYS-LC-01

Identifier Type: -

Identifier Source: org_study_id