Adjuvant Chemotherapy in Combination With Camrelizumab for Stage III Gastric Cancer (FOCUS-02)

September 14, 2024 updated by: Yu jiren

A Multi-center, Phase II Study to Evaluate Safety and Efficacy of Adjuvant Chemotherapy With Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin and Camrelizumab for Stage III Gastric Cancer (FOCUS-02)

This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the safety of tegafur gimeracil oteracil potassium capsule plus oxaliplatin and Camrelizumab as adjuvant therapy in stage III gastric cancer, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), overall survival (OS) and treatment completion rate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

  1. Study population: participants with stage III gastric cancer confirmed by postoperative pathology according to American Joint Committee on Cancer (AJCC) / Union for International Cancer Control (UICC) 8th Tumor Node Metastasis (TNM) staging classification.
  2. Sample size: single arm design was used in this study and 52 participants were estimated to be enrolled.
  3. Research content: In this study, within 4-6 weeks after the completion of the operation, the participants were selected and qualified for this study, and were scheduled to receive 200mg camrelizumab once intravenous infusion on the first day (q3w), then 130mg/m^2 oxaliplatin on the first day (q3w), and tegafur gimeracil oteracil potassium capsule was taken as follow: surface area is less than 1.25, 80mg per day, twice a day; ≥1.25 ~ <1.5, 100mg per day, twice a day; ≥1.5, 120mg per day, twice a day, and oral administration for 1-14 days every 3 weeks. Three weeks as a course of treatment, a total of 8 courses, after treatment, safety visit and survival follow-up will be carried out. A total of 3 years follow-up time is scheduled since the first medication, and the frequency is once every 3-6 months within 2 years, and once every 6-12 months for the third year.
  4. Adverse events (AEs) management: To minimize the risk of AEs, the investigators will monitor carefully to determine whether or not they are within the expected range. The degree of AEs is evaluated according to The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.0). Investigators will also conduct a thorough examination and adopt an appropriate system to take any necessary measures to deal with AEs.

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 (Actual)

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.
52

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
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Lishui, Zhejiang, China, 323000
        • Lishui Central Hospital
      • Taizhou, Zhejiang, China, 317000
        • Taizhou Hospital
      • Wenzhou, Zhejiang, China, 325027
        • The Second Affiliated Hospital of Wenzhou Medical University

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

Description

Inclusion Criteria:

  1. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).
  2. The gender is not limited. Age: ≥ 18 years and ≤ 75 years old.
  3. Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology.
  4. Without evidence of distant metastatic disease before operation by imaging.
  5. Received D2 or D2+ radical gastrectomy by open surgery (R0 resection).
  6. Stage III gastric cancer confirmed by postoperative pathology (AJCC/UICC 8th TNM staging classification).
  7. Participants with a performance status of 0 ~ 1 on the Eastern Cooperative Oncology Group (ECOG) within 7 days before the first dose of study treatment.
  8. Life expectancy ≥ 6 months.

  9. The functions of the vital organs meet requirements as follow (within 14 days before the first dose of study treatment, participant has not received treatment of blood transfusion, albumin, recombinant human thrombopoietin or granulocyte stimulating factor):

    A. Hematological function：

    • White blood cell count (WBC): 3.5 × 10 ^ 9 / L ~12.0 × 10 ^ 9 / L；
    • Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L；
    • Platelet count (PLT) ≥ 100 × 10 ^ 9 / L；
    • Hemoglobin (Hb) ≥ 90 g / L.

    B. Hepatic function：

    • Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal);
    • Aspartate aminotransferase (AST) ≤ 2.5 × ULN;
    • Alanine aminotransferase (ALT) ≤ 2.5 × ULN;
    • Albumin (ALB) ≥ 30 g / L.

    C. Renal function：

    • Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml / min for those with creatinine level > 1.5 × ULN.

    D. Coagulation function：

    • International normalized ratio (INR) ≤ 1.5;
    • Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  10. Female of childbearing age must meet requirements: urine pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of camrelizumab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. For the male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of camrelizumab, or 180 days after the last dose of chemotherapy, whichever is longer).

Exclusion Criteria:

  1. Received previous chemotherapy, radiotherapy, targeted therapy or immunotherapy.
  2. Previous or concurrent have other active malignant tumors (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).
  3. Existence of unrecovered complications after radical gastrectomy before the first dose of study treatment (including but not limited to: infection, gastrointestinal bleeding/ obstruction, anastomotic fistula, pancreatic fistula and anastomotic stenosis).
  4. Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV), echocardiogram shows left ventricular ejection fraction (LVEF) < 50%.
  5. Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).
  6. Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.
  7. Participants with active tuberculosis.
  8. Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.
  9. Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.
  10. Females who are pregnant or breastfeeding or expecting to conceive during the study period.
  11. Participants who need long-term systemic steroid therapy (> 10 mg/d prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.
  12. Concurrent or previous have severe allergic reaction to any antibody-based drugs.
  13. Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia).
  14. Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.
  15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  16. Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.
  17. Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.

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 and chemotherapy
Participants receive camrelizumab 200 mg intravenously (IV) on the first day (q3w), then oxaliplatin 130 mg/m^2, IV on the first day (q3w), and tegafur gimeracil oteracil potassium capsule 80 mg/m^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Three weeks as a course of treatment, a total of 8 courses.
Drug: Camrelizumab
Camrelizumab, 200 mg IV for 30-60 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.
Other Names:
  • SHR-1210
Drug: Oxaliplatin
Oxaliplatin: 130 mg/m^2 IV for 2-6 hour in first day which will be administered at least 30 min after completion of camrelizumab administration, every 3 weeks. Repeated every 21 days, 21 days for a cycle.
Drug: Tegafur gimeracil oteracil potassium capsule
Tegafur gimeracil oteracil potassium capsule: 80 mg/m^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Repeated every 21 days. 21 days for 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
The incidences and types of adverse events
Time Frame: 9 months
The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
9 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
Disease-free survival (DFS)
Time Frame: 3 years
Disease-free survival (DFS)
3 years
Overall survival (OS)
Time Frame: 3 years
Overall survival (OS)
3 years
Treatment completion rate
Time Frame: 6 months
Percentage of participants who complete eight cycles of chemotherapy in combination with Camrelizumab.
6 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.
Yu jiren

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: Jiren Yu, First Affiliated Hospital of Zhejiang 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.
September 9, 2020

Primary Completion (Actual)

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 29, 2023

Study Completion (Estimated)

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.
March 29, 2026

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).
August 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.
August 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.
August 17, 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.
September 19, 2024

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.
September 14, 2024

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.
September 1, 2024

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.
  • IIT20200046C-R1

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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