Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric Cancer

April 14, 2022 updated by: Houxinfang, Henan Cancer Hospital

A Phase II Clinical Study of Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the First-line Treatment of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

The purpose of this study is to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer, and to further explore the curative effect of PD - L1 expression in tumor tissue, EBV virus content, microsatellite instability (MSI), DNA mismatch repair (MMR), tumor mutation load (TMB), lymphocyte subgroup and cytokines.

Study Overview

Status

Status

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

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

Gastric cancer is a common malignant tumor of digestive tract.The incidence of gastric cancer in China accounts for about half of the world's total, the incidence rate ranks second, and the mortality rate ranks second.Moreover, the proportion of early gastric cancer in China is very low, only about 20%. Most of them are in advanced stage at the time of discovery. The overall 5-year survival rate is less than 15%, which seriously threatens the health and life of Chinese people.For nearly 90% of HER2 negative patients with advanced gastric and gastroesophageal junction adenocarcinoma (g / GEJ), the current first-line treatment option is chemotherapy, and the efficacy of available drugs is very limited.The ORR of the first-line chemotherapy is about 40%, and the OS is about 10 months. New therapeutic drugs are urgently needed to improve the efficacy of advanced G/GEJ.The purpose of this study was to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer.

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.
46

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.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Henan
      • Ho-nan, Henan, China, 450000
        • Recruiting
        • Henan Tumor Hospital
        • Contact:

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. Age 18-75 years old, no gender limit.
  2. ECOG 0-1; estimated survival time ≥12 weeks.
  3. Histopathologically confirmed unresectable locally advanced or metastatic HER-2 negative gastric adenocarcinoma.
  4. At least one measurable lesion (RECIST1.1 standard).
  5. Have not received systemic treatment for inoperable or metastatic gastric adenocarcinoma, past (new) adjuvant chemotherapy and adjuvant radiotherapy treatment ended to enrollment> 6 months.
  6. For local lesions (non-target lesions) palliative treatment (mainly local radiotherapy) end time to random entry time> 2 weeks.

  7. The main organs and bone marrow function are basically normal:

    1. Routine blood: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥80g/L;
    2. Liver function: TBiL≤1.5×ULN; ALT/AST≤2.5×ULN (for patients with liver metastases, ≤5ULN);
    3. Renal function: serum creatinine≤1.5×ULN and creatinine clearance rate>60mL/min;
    4. INR≤1.5×ULN and activated partial thromboplastin time ≤1.5×ULN.
  8. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.
  9. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age shall take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.

Exclusion Criteria:

  1. Patients with symptomatic central nervous system disease or meningeal metastasis; for patients with brain metastases who have received previous treatment, if the clinical condition is stable and imaging evidence does not show disease progression within 4 weeks before the first treatment, they can be considered for inclusion.
  2. Patients who have previously been treated with albumin-bound paclitaxel or paclitaxel.
  3. Received major surgery (craniotomy, thoracotomy or laparotomy), open biopsy or major traumatic injury within 28 days before enrollment, or expected major surgery during the study treatment period.
  4. Suffered from other malignant tumors in the past 5 years (except for cured skin basal cell or squamous cell carcinoma, or carcinoma in situ such as cervix and breast).
  5. The investigator believes that it will affect the subjects' ability to receive the treatment of the study protocol and are not controlled for serious medical diseases, such as combined serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Active peptic ulcer, severe infection, etc.
  6. Symptomatic congestive heart failure or cardiac color Doppler ultrasound examination shows LVEF (left ventricular ejection fraction <50%).
  7. Any arterial thromboembolic events, including unstable angina pectoris and cerebrovascular accidents, occurred within 6 months before being selected for treatment.
  8. A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment.
  9. Participate in other clinical trials 28 days before enrollment, unless participating in observational (non-interventional) clinical research or in the follow-up phase of interventional research.
  10. Patients with a history of interstitial lung disease, non-infectious pneumonia, or active tuberculosis.
  11. Patients with congenital or acquired immune deficiency, active hepatitis B or C.
  12. The patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes. Those who are still using it within 2 weeks before enrollment.
  13. Patients with difficult-to-control effusion, accompanied by severe pleural effusion, abdominal effusion and other clinical symptoms.
  14. Patients with grade ≥ 2 sensory or motor neuropathy; patients with peripheral neuropathy NCT-CTCAE ≥ 2.
  15. People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders.

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+albumin-bound paclitaxel+S-1
Other: Camrelizumab, Albumin-bound paclitaxel, S-1
Camrelizumab: 200mg, iv, Q3W, d1; Albumin-bound paclitaxel: 125mg/m2, iv, d1, 8, Q3W; S-1: According to the patient's body surface area, the dosage is set to 40, 50, 60 mg/time, bid, po, taking 2 weeks, and stopping the drug for 1 week as a 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
Objective response rate (ORR)
Time Frame: up to 2 years
Defined as the proportion of patients with a documented complete response, and partial response (CR+PR).
up to 2 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
Disease control rate (DcR)
Time Frame: up to 2 years
defined as the proportion of patients with complete response, partial response and disease stabilization (CR+PR+SD).
up to 2 years
Overall survival (OS)
Time Frame: up to 2 years
Defined as the date from random grouping to death from any cause.
up to 2 years
Progression free survival (PFS)
Time Frame: up to 2 years
Defined as the time betwween the onset of treatment and the observation of disease progression or death from any cause.
up to 2 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.
Henan Cancer 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 (Actual)

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.
August 17, 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.
December 31, 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.
December 31, 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).
December 14, 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.
December 14, 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.
December 19, 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.
April 15, 2022

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.
April 14, 2022

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, 2021

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.
  • YXGC-001

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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