Status:
UNKNOWN
A Safety and Efficacy Trial of Docetaxel With or Without XH1 in Non-small Cell Lung Cancer (NSCLC) Patients
Lead Sponsor:
Haining Health-Coming Biotech Co., Ltd.
Collaborating Sponsors:
Alphacait, LLC
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective, randomized, multicenter clinical study designed to evaluate its safety and efficacy by using Docetaxel with or without Traditional Chinese Medicine XH1 in patients with Stage ⅢB...
Detailed Description
Lung cancer is one of the most common malignant tumors in the world and has become the No. 1 cause of death from malignant tumors in China. Non-small cell lung cancer (NSCLC) includes squamous cell ca...
Eligibility Criteria
Inclusion
- Pathologically diagnosed IIIB or IV non-small cell lung cancer and EGFR negative
- Previously accepted first-line standard treatment failure or recurrence
- At least one measurable lesion
- From the last radiotherapy interval of at least 4 weeks, recovery from acute toxicity of radiation, prophylactic brain radiotherapy or palliative bone metastases lesions except radiotherapy
- Any gender, age ≥18 years
- ECOG PS : 0-2 points
- Expected survival ≥ March
- The level of organ function meets the following criteria (1) subject to the standard blood test: ANC ≥ 1.5 × 10 9 / L, PLT ≥ 8 0 × 10 9 / L, Hb ≥ 100 g / L (2) biochemical tests must meet the following criteria: TBIL \<1.5 × U LN, ALT, AST \<2 .5 × ULN ( if liver ALT, AST can be \<5 × U LN), BUN, and Cr ≤ 1 × ULN)
- Patients must be willing to eight weeks after the use of appropriate methods of contraception and the last administration of the test drug during the test, or surgically sterile
- Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up
Exclusion
- Symptomatic brain metastasis (could still enroll into the study if treatment finished 21 days prior to the enrollment and the patient is stable, but brain MRI, CT or angiogram is needed to rule out no intracranial hemorrhage)
- Following cardiac disease: second-degree or above cardiac ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval male\>450 ms, female\>470ms), according to NYHA criteria, III to IV cardiac insufficiency, or echocardiogram reveals left ventricular ejection fraction (LVEF) \<50%
- History of pulmonary interstitial lung disease or active interstitial lung disease;
- Coagulation dysfunction (INR \>1.5 or PT\>ULN+ 4sec, or PTT\>1.5 ULN), with bleeding tendency or currently receiving thrombolysis therapy or anticoagulation treatment;
- Major surgery, severe traumata, fracture or ulcers within past 4 weeks.
- Active infections requiring antimicrobial therapy (e.g., requires the use of antimicrobial drugs, antiviral, antifungal therapy)
- Participation of other cancer chemotherapy clinical study within past 4 weeks;
- History of uncured coexisting cancer, not including cured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer
- Pregnant or breast feeding women; fertile patients not willing or able to take effective contraceptive measures
- Any circumstances that might affect the proceeding of the clinical trial and/or research result analysis, as determined by the clinical investigator(s)
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03407300
Start Date
February 1 2018
End Date
February 1 2019
Last Update
September 13 2018
Active Locations (1)
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1
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310000