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

January 15, 2019 updated by: Henan Cancer Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Tian Tongde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Epirubicin plus SHR1210
First intravenous injection of epirubicin injection, D1,30mg/m^2 Then intravenous administration with SHR-1210,D1, a fixed dose of 200mg, D1,30min 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.
Drug: Epirubicin 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 6 month
Objective Response Rate
6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 2 years
Overall Survival
2 years
PFS
Time Frame: 2 years
Progression Free Survival
2 years
DCR
Time Frame: 2 years
Disease Control Rate
2 years
AE
Time Frame: 2 year
Adverse reactions
2 year
characteristic antigen on the surface of immunogenic dead cells
Time Frame: 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.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan Cancer Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jiangsu HengRui Medicine Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tongde Tian, Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR-1210-EPI-II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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