The Conversion Therapy of Chemotherapy Plus Camrelizumab in Metastatic Gastric Cancer

February 4, 2024 updated by: Quan Wang

PD-1 Inhibitor Plus Chemotherapy as Conversion Therapy in Unresectable Gastric Cancer (STARS-GC01): A Single-arm, Single-center, Prospective Clinical Study.

Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric cancer patients diagnosed for the first time in China have a higher proportion of advanced stages and a higher postoperative metastasis rate.Studies have shown that patients with good pathological response after preoperative neoadjuvant therapy (such as tumor regression grade, TRG0 or 1) have a better prognosis.The purpose of this study is to treat patients with advanced gastric cancer who are difficult to perform R0 surgery with chemotherapy combined with immunotherapy. At the same time as the primary cancerous lesions are reduced, the distant metastatic lesions are effectively controlled in order to perform R0 surgery and to improve the survival rate of patients with advanced gastric cancer.

Study Overview

Status

Status

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

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

The interventions include camrelizumab and chemotherapy selected based on the use of different metastatic sites as conversion therapy.

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.
37

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 Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • First Hospital of Jilin 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. The patient voluntarily participates in the study with full informed consent and signs a written informed consent form.
  2. Age 18-75 years old, male or female.
  3. HER-2 negative unresectable gastric cancer.
  4. Patients with gastric cancer who PD-L1+（CPS≥1）or MSI-H/dMMR, or EBV（+）.
  5. Patients were assessed by physicians before enrollment to determine eligibility for conversion therapy.
  6. The expected survival time of the patient is≥ 12 weeks.
  7. ECOG 0-1.
  8. The patient has good organ function: no blood transfusion or colony-stimulating factor and thrombopoietin have been received in the 14 days before the first study, neutrophil count ≥1.5×109/L, platelet count ≥80×109/ L hemoglobin ≥ 80 g/L, serum creatinine ≤ 1.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT, AST ≤ 2.5 times ULN (without liver metastasis) or ≤ 5 times ULN (such as liver metastasis occurred), albumin ≥30 g/L. Requirements for coagulation function: International normalized ratio (INR) ≤ 1.5 times ULN, prothrombin time (PT) ≤ 1.5 times ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN. Requirements for electrolytes: the corrected serum calcium, blood potassium, and blood magnesium are within the normal range;
  9. Women of childbearing age are required to have a pregnancy test (serum or urine) within 7 days of entry and the results are negative and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last drug is given. For men, it should be surgical sterilization or consent to the use of appropriate methods of contraception during the trial and 8 weeks after the last administration of the experimental drug.

Exclusion Criteria:

  1. Those who are known to be allergic to the study drug or any of its excipients or have had severe allergic reactions.
  2. Patients who have received chemotherapy and monoclonal antibodies within 21 days and those who have received radiotherapy within 14 days.
  3. Participated in other clinical trials within 21 days before screening.
  4. Other malignant tumors have been diagnosed within 5 years before entering the study, except for skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or intraductal carcinoma in situ of the breast that can be treated locally and cured.
  5. There is uncontrollable or symptomatic active central nervous system (CNS) metastasis, which can be manifested as clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and/or progressive growth; imaging Prompt asymptomatic spinal cord compression, except for those who have been evaluated by specialists as stable and do not need treatment for the time being; For those who have received CNS metastasis treatment, imaging examinations during the screening period have shown that they have been stable for ≥4 weeks and have been stopped before the first study administration Except for systemic hormone therapy (prednisone or other curative hormones with a dose> 10 mg/day) for ≥ 4 weeks.
  6. Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion.
  7. Poorly controlled tumor-related pain; patients who need analgesic treatment, must receive a stable dose of treatment before participating in the study; should be suitable for palliative radiotherapy (for example, bone metastasis or metastasis that causes nerve damage) before enrollment. If appropriate, consider local treatment of asymptomatic metastatic lesions whose further growth may cause functional defects or intractable pain (for example, epidural metastases not related to spinal cord compression).
  8. Peripheral neuropathy or hearing loss ≥ 2 (according to NCI-CTCAE 5.0).
  9. Pregnant or (confirmed by blood or urine HCG test) or breastfeeding women or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until after the last trial treatment at least 6 months.
  10. Patients with moderate to severe liver and kidney dysfunction.
  11. Diabetes that is difficult to control (refers to the large fluctuations in blood glucose under standard insulin treatment and frequent blood glucose monitoring, which affects the life of the patient and frequent hypotension).

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: Conversion therapy
Camrelizumab combined with chemotherapy selected per metastasis site.
Drug: Camrelizumab
200mg, intravenous drip administration, d1, every 3 weeks.
Other Names:
  • SHR-1210
Drug: S-1
Oral, d1-14, every 3 weeks.
Other Names:
  • Tegafur Gimeracil Oteracil Potassium Capsule
Drug: Oxaliplatin
130mg/m² intravenous drip administration, d1, every 3 weeks(For patients with liver and/or para-aortic lymph node metastasis).
Drug: Paclitaxel
Intraperitoneal paclitaxel 20 mg/m² and intravenous paclitaxel 50 mg/m² on days 1 and 8, every 3 weeks(For patients with peritoneal metastasis ).

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: Within 1 month of surgery.
Defined as no residue under the microscope after resection
Within 1 month of surgery.

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
Pathologic complete response
Time Frame: Within 1 month of surgery.
The number of people who have achieved complete pathological remission accounted for the proportion of people who met the plan.
Within 1 month of surgery.
Overall survival
Time Frame: From the start of system therapy to death from any cause.
The time from the start of system therapy to the death of any cause.
From the start of system therapy to death from any cause.
2-year survival rate
Time Frame: 2 years from the start of system therapy.
Percentage of subjects who are alive without death event at two years.
2 years from the start of system therapy.
Adverse events(all grades）
Time Frame: From the start of system therapy to 6 months after surgery.
Assessed per Common Terminology Criteria for Adverse Events(CTCAE) version 5.0
From the start of system therapy to 6 months after surgery.
Serious adverse events(≥grade 3）
Time Frame: From the start of system therapy to 6 months after surgery.
Assessed per Common Terminology Criteria for Adverse Events(CTCAE) version 5.0
From the start of system therapy to 6 months after surgery.

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.
Quan Wang

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: Quan Quan, MD, The First Hospital of Jilin 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.
August 17, 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.
May 6, 2023

Study Completion (Actual)

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 6, 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).
November 20, 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.
January 1, 2021

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 5, 2021

Study Record Updates

Last Update Posted (Estimated)

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 7, 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.
February 4, 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.
February 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.
  • STARS-GC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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