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

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Lung Cancer
• Intervention / Treatment: Drug: Chlorogenic acid

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）.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sheng Yang, Dr; Phone Number: 8613683260156; Email: medart@126.com
• Study Contact Backup: Name: Jianping Xu, Dr; Phone Number: 8613651379626; Email: 13651379626@139.com

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • Cancer Hospital Chinese Academy of Medical Sciences
    • Principal Investigator: Yuankai Shi, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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%.

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Yuankai Shi, Dr, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LYS-LC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No