A Study to Evaluate the Efficacy and Safety of Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative Microsatellite Stability (MSS) Advanced or Metastatic Gastric (GC) or Gastroesophageal Junction (GEJ) Cancer

April 1, 2022 updated by: Jiuda Zhao

An Open-Label, Multi-Center, Phase II Study to Evaluate the Efficacy and Safety of PD-1 Antibody Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative MSS Advanced or Metastatic GC or GEJ Cancer

To evaluate the efficacy and safety of Sintilimab combined with apatinib and chemotherapy as First-line or second-line Therapy in Treatment of HER-2 negative MSS Advanced or Metastatic GC or GEJ Cancer. At the same time, the correlation between tissue programmed death ligand-1(PD-L1) expression and blood circulating tumor cell(CTC) counts and the efficacy of immune combination therapy was also explored.

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

Participants receive Sintilizumab 200 mg, intravenously (IV) every 3 weeks(Q3W);plus Apatinib 250 mg twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days; plus Tegafur gimeracil oteracil potassium capsules (40mg for body surface area < 1.25/m^2, 50mg/m^2 for body surface area 1.25-1.5m^2, 60mg for body surface area > 1.5/m^2) BID by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus Oxaliplatin 85 mg/m^2, IV Q3W; for 4-6 cycles followed by Cindilizumab plus Tegafur gimeracil oteracil potassium capsules.

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.
31

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 Locations

  • China
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Recruiting
        • Affiliated Hospital of Qinghai University
        • 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. Patients with inoperable advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma confirmed by histology, and HER-2 negative by immunohistochemistry. HER-2 negative was defined as immunohistochemistry 0-1 + or 2 + but fish results were negative.
  2. According to recist1 1 measurement standard at least one or more target lesions can be measured.
  3. Patients with microsatellite stability (MSS type) or normal mismatch repair protein (PMMR) confirmed by immunohistochemistry or second-generation sequencing..
  4. Aged 18-75.
  5. The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1 points.
  6. Life expectancy is more than 3 months.
  7. The blood routine examination was basically normal within 1 week before enrollment (taking the normal value in the laboratory of each research center as the standard). The white blood cell count (WBC) ≥ 2.5 × 10^9 / L or neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 100 × 10^9/L； Hemoglobin ≥ 9.0 g / dl. Patients can receive blood transfusion or erythropoietin treatment to meet this standard.
  8. The liver and kidney function, nail function and coagulation function were basically normal within 1 week before enrollment (based on the normal values in the laboratories of each research center). Total bilirubin (TBIL) ≤ 1.5 × Upper limit of normal value (ULN); alanine aminotransferase (SGPT / ALT) ≤ 2.5 × ULN (patients with liver metastasis) ≤ 5 × ULN);Aspartate aminotransferase (SGOT / AST) ≤ 2.5 × ULN (patients with liver metastasis) ≤ 5 × ULN);Creatinine clearance rate (CCR) ≥ 60 ml / min; Urinary protein < 2 +; If urinary protein ≥ 2 +, 24-hour urinary protein must be ≤ 1g; Thyroid stimulating hormone (TSH) ≤ upper limit of normal value (ULN); in case of abnormality, T3 and T4 levels shall be measured; if T3 and T4 levels are normal, they can be selected. International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN。
  9. The patient is willing and able to comply with the provisions of the study protocol during the study.
  10. Before entering the study, during the study and within 6 months after the end of treatment, patients with fertility must take effective contraceptive measures (hormone or barrier contraception; abstinence).
  11. The subject agreed not to participate in another intervention study when receiving the study drug in this study. Subjects ended the last study for more than 1 month.
  12. Subjects who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy or chemoradiotherapy) of GC / GEJ must complete the last dose of treatment at least 6 months before the first study treatment. Palliative radiotherapy is allowed, but it must be completed 2 weeks before the start of study treatment.

Exclusion Criteria:

  1. Patients who have received chemotherapy, radiotherapy or biological therapy within two weeks. Received any investigational drug within 4 weeks before the start of study treatment.
  2. Pregnant or lactating women; women with fertility have a positive pregnancy test or no pregnancy test at the time of screening.
  3. Severe / uncontrolled intermittent disease / infection.
  4. Obvious cardiovascular disease (history of congestive heart failure > NYHA class II, unstable angina pectoris or myocardial infarction, unstable angina pectoris or myocardial infarction, or severe arrhythmia in the past six months).
  5. History or evidence of hereditary bleeding syndrome or coagulation disease with bleeding risk, history of thrombotic disease and active gastrointestinal bleeding.
  6. There have been arterial thromboembolism events in the past 6 months, including transient ischemic attack and cerebrovascular accident.
  7. Patients with previous malignant tumors, unless the previous malignant tumors have been diagnosed and treated for more than 5 years, and there is no evidence of recurrence.
  8. The subjects have known human immunodeficiency virus (HIV) infection or known positive detection history of active hepatitis B (positive HBsAg) or hepatitis C infection. The subjects with HBsAg negative but HBC AB positive will be tested for HBV DNA replication. If it is greater than the minimum copy number of HBV DNA, the subjects will be excluded. The subjects with seropositive but hepatitis C virus The subjects with negative replication results of (HCV) RNA test are eligible for inclusion.
  9. Patients with neuropathy > grade 3 at screening.
  10. Patients with QTc > 500msec during screening.
  11. Patients with meningeal disease and no other measurable brain metastasis were excluded.
  12. Have received bevacizumab, sorafenib, sunitinib or other VEGF pathway targeted therapy.
  13. Have a history of severe hemoptysis.
  14. Having a mental illness or social situation can hinder study compliance.
  15. A severe nonunion wound, ulcer, or bone fracture.
  16. Major surgery, open biopsy or major trauma within 28 days before enrollment, and minor surgery within 7 days before enrollment.
  17. Have a history of allergic reaction to compounds similar to the chemical composition of the study drug.
  18. Take chronic daily aspirin (> 325 mg / day), dipyridamole, ticlopidine, clopidogrel, cilostazol, non steroidal anti-inflammatory drugs and other drugs known to inhibit platelet function.
  19. Recent formal antihypertensive treatment still failed to control hypertension (systolic blood pressure greater than 140mmHg and diastolic blood pressure greater than 90mmHg), and the patients had obvious symptoms of hypertension.

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: Treatment of HER-2 Negative MSS Advanced Gastric
Sintilimab Plus Apatinib and Chemotherapy in Patients with Previously Untreated HER-2 negative MSS Advanced or Metastatic GC or GEJ Cancer
Drug: Sintilimab 200 mg, intravenously (IV) every 3 weeks(Q3W)
for 2-6 cycles followed by Sindilizumab plus Tegafur gimeracil oteracil potassium capsules.
Other Names:
  • Apatinib 250 mg twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days;
  • Tegafur gimeracil oteracil potassium capsules twice daily (BID) by continous oral adminstration for 14 days, every 3 weeks(Q3W)
  • Oxaliplatin 85 mg/m^2, IV every 3 weeks(Q3W)

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: 36 months
per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
36 months

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
Progression-free Survival (PFS)
Time Frame: 36 months
per RECIST 1.1
36 months
Disease Control Rate (DCR)
Time Frame: 36 months
per RECIST 1.1
36 months
Duration of Response (DoR)
Time Frame: 36 months
per RECIST 1.1
36 months
Adverse events (AEs)
Time Frame: 36 months
Number of Subjects with treatment-related adverse events
36 months

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.
Jiuda Zhao

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.
Second Hospital of Lanzhou 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 (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.
February 15, 2022

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.
June 1, 2024

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.
June 1, 2025

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).
January 19, 2022

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.
January 19, 2022

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.
January 31, 2022

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 11, 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 1, 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.
April 1, 2022

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.
  • AHQU-2022001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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