SHR-1210 Combined With Epirubicin in the Treatment of Extensive Disease Small Cell Lung Cancer

Clinical Study of PD-1 Monoclonal Antibody SHR-1210 Combined With Epirubicin in the Treatment of Extensive Small Cell Lung Cancer After First-line Treatment Failure

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03755115

Enrollment

Registered

2018-11-27

Start date

2019-02-01

Completion date

2020-05-31

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

ICD, PD1, ED-SCLC

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 patients, but it is easy to resist drug recurrence, which brings certain difficulties to clinical treatment. The signaling pathway activated by programmed cell death receptor 1 (PD-1) and its ligand (programmed death-ligand 1, PDL1) is a hotspot in recent years and has brought good news to cancer patients. However, PD1 inhibitors are only about 13% effective in treating lung cancer patients. Epirubicin is a classic drug that activates the immunogenicity of tumor tissues, induces tumor immunogenic death, and releases some marker proteins such as CRT, HMGB1, HSP and so on. These two drugs combine to enhance the anti-tumor effect of the human immune system.The investigators designed the study to explore the possibility of apatinib as the Second-line Therapy in ED-SCLC.

Interventions

DRUGEpirubicin plus SHR1210

First intravenous injection of epirubicin injection, D1,30mg/m\^2 Then intravenous administration with SHR-1210,D1, a fixed dose of 200mg, 30min per infusion, Q2W. The total dose of epirubicin is 360 mg/m\^2.next SHR-1210 single drug maintenance .Until to secdonary disease progression or intolerance side effects.Evaluate efficacy every 3 cycles.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. The subject is 18-75 years old when the informed consent form is signed, and the gender is not limited. 2. Histological or cytological diagnosis of patients with extensive small cell lung cancer (ED-SCLC). 3. 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. 4. Subjects have undergone rapid progression or relapse of drug resistance after first-line treatment. 5. 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 criteria

1\. Target disease

Design outcomes

Primary

Measure	Time frame	Description
ORR	6 month	Objective Response Rate

Secondary

Measure	Time frame	Description
PFS	2 years	Progression Free Survival
DCR	2 years	Disease Control Rate
OS	2 years	Overall Survival
AE	2 year	Adverse reactions
characteristic antigen on the surface of immunogenic dead cells	3 month	characteristic antigen on the surface of immunogenic dead cells,such as CRT(calnetulin),HSP(heat shock protein),HMGB1(High-mobility group box 1 protein),TIL (tumor infiltrating lymphocytes)，ATP,which are measured by IHC or ELISA.

Countries

China

Contacts

Primary ContactTongde Tian

tian_tong_de@163.com0086-15093118217

Backup ContactDu Yang

1061453586@qq.com0086-18737704121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026