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

NCT03751592 | Unknown Phase 1

• 1 other identifier: LYS-LC-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (1)

• disease control rate（DCR)

  Within the first 10 weeks after the first dose of chlorogenic acid for injection

Secondary Outcomes (4)

• 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

Study Arms (1)

Chlorogenic acid, Treatment, powder

EXPERIMENTAL

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

Interventions

Chlorogenic acid 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.

Chlorogenic acid, Treatment, powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Interventions

Chlorogenic Acid

Intervention Hierarchy (Ancestors)

Cinnamates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cyclohexanecarboxylic Acids

Study Officials

• Yuankai Shi, Dr

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Yang, Dr

CONTACT

8613683260156; medart@126.com

Jianping Xu, Dr

CONTACT

8613651379626; 13651379626@139.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 23, 2018
• Study Start: July 17, 2018
• Primary Completion: October 30, 2020
• Study Completion: April 30, 2021
• Last Updated: November 26, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)