Camrelizumab in Combination With Apatinib Mesylate, Paclitaxel-albumin and S-1 for Translational Treatment of Gastric Cancer

February 5, 2020 updated by: Zhongtao Zhang, Beijing Friendship Hospital

Efficacy and Safety of Camrelizumab in Combination With Apatinib Mesylate, Paclitaxel-albumin and S-1 for Translational Treatment of Gastric Cancer

This is an interventional clinical trial to assess the efficacy and safety of camrelizumab in combination with apatinib mesylate, paclitaxel-albumin and S-1 for translational treatment of gastric cancer.

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.

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.
30

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.
  • Name: Zhongtao Zhang
  • Phone Number: 8618811792819 8618811792819
  • Email: zhongtao.z@139.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age:18～70; expected survival>3 months
  2. pathologically diagnosed gastric cancer or esophageal-gastric-junction cancer, being predominantly adenocarcinoma
  3. no previous treatment of anti-cancer drugs
  4. ECOG score 0~2
  5. CT/MRI/PET-CT diagnosed as unresectable
  6. no disfunction of major organs

  7. lab results satisfy the following criteria:

    • Hb≥90g/L
    • WBC≥3.5×109/L
    • Neutrophil≥1.5×109/L
    • Plt≥100×109/L
    • ALT、AST≤2.5 upper limit (≤5 upper limit for patients with liver metastasis)
    • Tbil≤1.5 upper limit
    • serum creatinine≤1.5 upper limit

7.women at child-bearing age must be tested negative within 7 days before inclusion, and must be willing to take contraception measures during treatment and within 12 weeks after last dose of treatment; men must be sterilized or willing to take contraception measures during treatment and within 12 weeks after last dose of treatment 8.willing to join this research with hand-signed written Informed consent 9.good compliance for follow-up

Exclusion Criteria:

  1. patients with positive HER-2 test
  2. with conditions that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction
  3. allergic to carrizumab for injection, apatinib mesylate, paclitaxel for injection (albumin binding type) and tS-1 or relevant drug excipients; allergic to any other monoclonal antibodies; cannot tolerate radiation toxicity;
  4. with active autoimmune disease or autoimmune disease history, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy); patients with complete remission of childhood asthma and require no intervention can be included, whereas those who need medical intervention with bronchodilator cannot be included
  5. with congenital or acquired immune defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the lower detection limit of the analysis method) or combined hepatitis B and hepatitis C co infection
  6. immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroids in physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids for equivalent amount);
  7. inoculated live attenuated vaccine within 4 weeks before the first administration or during the study period
  8. severe infection (requiring intravenous drip of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or fever> 38.5° C of unknown cause during screening / before the first administration
  9. known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  10. objective evidence indicating previous or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pneumonia, drug-related pneumonia, severe impairment of lung function, etc
  11. patients with hypertension that cannot be restored to the normal range (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg) after treatment with antihypertensive drugs for 3 months
  12. patients with uncontrolled clinical symptoms or diseases of the heart, including but not limited to congestive heart failure (NYHA grade > II); unstable or severe angina; acute myocardial infarction within 6 months; patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; left ventricular ejection fraction (LVEF) < 50%
  13. patients at risk of serious bleeding, including but not limited to severe bleeding (bleeding > 30 ml within 3 months), hemoptysis (bleeding > 5 ml within 4 weeks), and thromboembolism events (within the past 12 months)
  14. with symptoms indicating Grade 2+ peripheral neuropathy
  15. participating in other clinical trials, or participating in any clinical study for drugs within previous 4 weeks
  16. other situations that the researchers regard as not suitable for inclusion.

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: Camrelizumab+Apatinib+Paclitaxel-albumin+S-1
Camrelizumab：D1, 200 mg ivgtt Apatinib Mesylate：D1~21, 250 mg, po qd Paclitaxel-albumin：D1&D8, 100～120 mg/m2 S-1：D1~14, 60mg bid
Drug: Camrelizumab+Apatinib+Paclitaxel-albumin+S-1
Combination therapy of 4 drugs, 21 days for one cycle.

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
R0 resection rate
Time Frame: 3 years
proportion of patients for whom radical resection can be achieved
3 years

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
ORR
Time Frame: 3 years
objective response rate
3 years
DFS
Time Frame: 3 years
disease free survival (period)
3 years
3-year DFS
Time Frame: 3 years
3-year disease free survival (rate)
3 years
PFS
Time Frame: 3 years
progression free survival (period)
3 years
OS
Time Frame: 3 years
overall survival (period)
3 years
1-year OS
Time Frame: 1 year
1-year overall survival (rate)
1 year
3-year OS
Time Frame: 3 years
3-year overall survival (rate)
3 years

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.
Beijing Friendship Hospital

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.
  • Study Director: Wei Deng, Beijing Friendship Hospital

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.
March 1, 2020

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.
February 28, 2023

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.
February 28, 2023

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).
February 5, 2020

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.
February 5, 2020

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.
February 6, 2020

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.
February 6, 2020

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.
February 5, 2020

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.
February 1, 2020

More Information

Terms related to this study

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.
  • BFH-CamrelizumabCombo4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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