Status:
UNKNOWN
Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer
Lead Sponsor:
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Advanced Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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-s...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).
Key Trial Info
Start Date :
July 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03751592
Start Date
July 17 2018
End Date
April 30 2021
Last Update
November 26 2018
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021