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

NCT ID: NCT02195453

Last Updated: 2014-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-12-31

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Yangzhengxiaoji Capsule

Gemcitabine or Pemetrexed

Cisplatin

Yangzhengxiaoji Capsule four granules t.i.d po

Group Type: EXPERIMENTAL

Yangzhengxiaoji Capsule

Intervention Type: DRUG

Gemcitabine 1000mg/m² or Pemetrexed 500mg/m² IV drip on D1 and D8,21 days for a cycle.

Cisplatin 75mg/m² IV drip for one day or two-three days total injection,21 days for a cycle.

Yangzhengxiaoji Capsule four granules t.i.d po.

Placebo Capsule

Gemcitabine or Pemetrexed

Cisplatin

Placebo Capsule four granules t.i.d po

Group Type: PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type: DRUG

Gemcitabine 1000mg/m² or Pemetrexed 500mg/m²IV drip on D1 and D8,21 days for a cycle.

Cisplatin 75mg/m² IV drip for one day or two-three days total injection, 21 days for a cycle.

Placebo Capsule four granules t.i.d po.

Interventions

Yangzhengxiaoji Capsule

Gemcitabine 1000mg/m² or Pemetrexed 500mg/m² IV drip on D1 and D8,21 days for a cycle.

Cisplatin 75mg/m² IV drip for one day or two-three days total injection,21 days for a cycle.

Yangzhengxiaoji Capsule four granules t.i.d po.

Intervention Type: DRUG

Placebo Capsule

Gemcitabine 1000mg/m² or Pemetrexed 500mg/m²IV drip on D1 and D8,21 days for a cycle.

Cisplatin 75mg/m² IV drip for one day or two-three days total injection, 21 days for a cycle.

Placebo Capsule four granules t.i.d po.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Jinming Yu

Shandong Cancer Hospital and Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinming Yu, PhD

Role: STUDY_CHAIR

Shandong Cancer Hospital and Institute

Jie Wang, PhD

Role: STUDY_CHAIR

Biejing Cancer Hospital

Central Contacts

Ligang Xing, M.D.

Role: CONTACT

xinglg@gmail.com

18053100188

Other Identifiers

yl-yxb08-lcsyfa-201302

Identifier Type: -

Identifier Source: org_study_id