Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer

Shandong First Medical University

Status and phase: Unknown; Phase 4

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Yangzhengxiaoji Capsule; Drug: Placebo Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02195453

yl-yxb08-lcsyfa-201302

Details and patient eligibility

About

The purpose of this study is to observe quality of life and treatment side effects in patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and Yangzhengxiaoji capsule.

Enrollment: 520 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histology and/or cytology confirmed stage Ⅳ NSCLC patients;

2. With at least one measurable solid tumor (RECIST standard version 1.1): tumor >=10 mm in diameter on CT or MRI images, or lymph node >=15 mm in diameter on CT or MRI images;

3. Eastern Cooperative Oncology Group(ECOG) score 0-1, expectant survival > 3 months;

4. Age: 18-70 years;

5. Normal organ function:

   Bone marrow: neutrophils (ANC) count>=1.5×10^9/L, Platelets count>=100×10^9/L, hemoglobin>=90g/L；Renal function, serum creatinine<=1.5 mg/dl, and/or creatinine clearance or>=60 ml/min; Liver function: total serum bilirubin levels <= 1.5 times the upper limit of normal (ULN), serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT)<=2.5 times the ULN, if abnormal liver function caused by the underlying malignancy, the AST and ALT >=5 times ULN;

6. For patients with brain metastases, bone metastases or pleural effusion, systemic chemotherapy is proposed after the effective local treatment to control symptoms;

7. Informed consent.

Exclusion criteria

1. Clinically significant hepatic dysfunction: AST or ALT > 2.5 times the ULN, total serum bilirubin levels > 1.5 times the ULN; clinically significant renal insufficiency: serum creatinine > 1.5 times the ULN;
2. Severe heart disease: New York Heart Association class Ⅲ-IV class of heart failure, unstable angina, myocardial infarction, coronary revascularization six months before randomization;
3. Spleen resection or combined with other severe hematopoietic system diseases;
4. Uncontrolled diabetes, hypertension (above 180/120mmHg), infection or severe gastrointestinal ulcers;
5. History or present with other cancer, except for non melanoma skin cancer, cervical cancer in situ and other cured cancer for at least 5 years;
6. Mental illness, without legal capacity or limited capacity;
7. Pregnancy, lactation or patients with pregnancy plan;
8. Participated in other clinical trail in the past 1 months or participating in other trail now;
9. Other unsuitable condition decided by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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520 participants in 2 patient groups, including a placebo group

Yangzhengxiaoji Capsule

Experimental group

Description:

Gemcitabine or Pemetrexed Cisplatin Yangzhengxiaoji Capsule four granules t.i.d po

Treatment:

Drug: Yangzhengxiaoji Capsule

Placebo Capsule

Placebo Comparator group

Description:

Gemcitabine or Pemetrexed Cisplatin Placebo Capsule four granules t.i.d po

Treatment:

Drug: Placebo Capsule