Status:
UNKNOWN
SHR-1210 Combined With Epirubicin in the Treatment of Extensive Disease Small Cell Lung Cancer
Lead Sponsor:
Henan Cancer Hospital
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Small Cell Lung Cancer Extensive Stage
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Patients with extensive disease SCLC after failure of first-line treatment were enrolled with SHR-1210 and epirubicin for 3 cycles to evaluate initial efficacy
Detailed Description
Small cell lung cancer is a neuroendocrine tumor with strong invasiveness, rapid growth rate and early metastasis in lung cancer. The systemic chemotherapy response rate is high in a wide range of pat...
Eligibility Criteria
Inclusion
- The subject is 18-75 years old when the informed consent form is signed, and the gender is not limited.
- Histological or cytological diagnosis of patients with extensive small cell lung cancer (ED-SCLC).
- Must provide specimens of tumor tissue at or after diagnosis of advanced or metastatic tumors or consent to biopsy, formalized or freshly obtained, formalin-fixed, paraffin-embedded (FFPE) within 1 month prior to the first dose. After the tumor tissue block can cut at least 10 slices for staining and detection.
- Subjects have undergone rapid progression or relapse of drug resistance after first-line treatment.
- According to the RECIST 1.1 standard, subjects must have a target lesion that can be measured by CT or MRI.
- 6, ECOG PS score: 0-1 points. 7. The expected survival period is ≥ 3 months. 8, the main organ function meets the following criteria: a) blood routine (no blood transfusion within 14 days, no G-CSF, no use of drugs to correct): absolute neutrophil ≥ 1.5 × 109 / L, platelets ≥ 100 × 109 / L, hemoglobin ≥ 90 g / L, white blood cells ≥ 4.0 × 109 / L and ≤ 15 × 109 / L; b) blood biochemistry: total bilirubin ≤ 1.5 ULN, AST / ALT ≤ 2.5 ULN, (if liver metastasis, then ≤ 5 times the upper limit of normal value), ALB ≥ 30 g / L, serum creatinine ≤ 1.5 ULN; c) Coagulation function: APTT ≤ 1.5 × ULN and prothrombin time - international normalized ratio (PT-INR) \< 1.5xULN ( Did not receive anticoagulant therapy).
- 9\. Volunteer to participate in clinical trials and sign informed consent, good compliance
Exclusion
- 1\. Target disease exclusion criteria: 1) Exclude subjects without measurable lesions 2) Subjects who can be surgically resected or radically treated. 3) Subjects who have received anti-PD-1 (L1) or CTLA4 mAb treatment.
- History and comorbidities: 1) Exclude any active, known or suspected autoimmune disease in the subject 2) Exclude 2, use anti-tumor vaccine or other anti-tumor with immune stimulation within 1 month before the first dose Subjects treated with drugs. 3) Exclude subjects who are highly suspected of having interstitial pneumonia. 4) Subjects who excluded other active malignancies requiring simultaneous treatment excluded subjects with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias, and grade III to IV cardiac insufficiency. 5) Exclude subjects with active tuberculosis (TB). 6) Exclude subjects who had severe infections within 4 weeks prior to the first dose. Exclude subjects with any active infection. 7) Exclude subjects who are ready or have undergone tissue/organ transplantation. 8) Exclude subjects who have been vaccinated or will be vaccinated within 30 days prior to the first dose.
- 3\. Physical examination and laboratory examinations 1) A known history of human immunodeficiency virus (HIV) is known or known to have acquired immunodeficiency syndrome (AIDS). 2) Untreated active hepatitis. 3) Exclude subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- 4, allergic reactions and adverse drug reactions 1) severe allergic reactions to other monoclonal antibodies. 2) Allergic or intolerant to the infusion. 3) Serious intolerance to epirubicin or toxicity.
- 5\. Exclude subjects with mental illness, alcoholism, refrain from quitting, drug use or substance abuse.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03755115
Start Date
February 1 2019
End Date
May 31 2020
Last Update
January 16 2019
Active Locations (1)
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1
Tian Tongde
Zhengzhou, Henan, China, 450000