Clinical trial NCT03751592: Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer
Official title: A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Lung Cancer
Lead sponsor: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2018-11-23
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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）.

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).

Primary outcomes:
measure: disease control rate（DCR)
timeFrame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Secondary outcomes:
measure: objective response rate (ORR)
timeFrame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
measure: progress free survival(PFS)
timeFrame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
measure: Overall Survival（OS）
timeFrame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
measure: Eastern Cooperative Oncology Group （ECOG） score standard
timeFrame: Within the first 10 weeks after the first dose of chlorogenic acid for injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yuankai Shi, Dr
role: PRINCIPAL_INVESTIGATOR
References: