Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

February 1, 2024 updated by: Wuhan Union Hospital, China

A Clinical Study of the Efficacy and Safety of Sintilimab in Combination With Chemotherapy (S-1/Oxaliplatin, SOX) and Radiotherapy for the Neoadjuvant Treatment of Locally Advanced Esophagogastric Junction Adenocarcinoma

The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (S-1+Oxaliplatin) and radiotherapy for locally advanced esophagogastric junction adenocarcinoma.

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.

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 (Estimated)

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.
32

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
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Min Jin
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-70, male and female.
  • Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aNxM0 (AJCC v8), Siewert typed as type II-III.
  • No previous anti-tumor treatment.
  • ECOG score was 0-1.
  • Expected survival of ≥ 6 months
  • Adequate organ reserve function.

Exclusion Criteria:

  • Malignant disease other than gastric cancer (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ) diagnosed within 5 years.
  • Known Her-2 positive( IHC 3+ or FISH positve).
  • Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody
  • Severe allergic reaction to monoclonal antibody.
  • Receiving systemic glucocorticoid therapy within 7 days prior to the first dose of the study
  • Known endoscopic signs of active bleeding from the lesion

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: Neoadjuvant immunotherapy-chemoradiotherapy

This is a one arm study, enrolled locally advanced EGJ patients will receive Sintilimab (PD-1 inhibitor) and combined with preoperative chemoradiotherapy and operation.

generic name：PD-1; dosage form：Injection; dosage：200mg (20ml)； frequency：every 3 weeks； duration：3 times before operation and 3-5 times after operation
Drug: PD-1inhibitor
Patients receive 3 cycles of preoperative chemotherapy with Sintilimab（PD-1 inbibitor） and SOX (every 3 weeks), followed by radiotherapy (total dose of 36-40Gy in 18-22 fractions) during cycle 1 of the combination. Radical surgery for gastric cancer will be performed within 4-6 weeks after completion of neoadjuvant treatment, followed by 3-5 cycles of postoperative adjuvant chemotherapy with the SOX regimen.

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
Pathologic Complete Response
Time Frame: 10 days after operation
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
10 days after operation

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
Objective response rate (ORR)
Time Frame: 6 months after the recruitment of the last subject.
The Objective response rate (ORR) is defined as the proportion of patients with a complete response (CR) or a partial response (PR) to preoperative therapy. The ORR will be evaluated using the RESIST1.1 protocol.
6 months after the recruitment of the last subject.
Overall survival (OS)
Time Frame: Through study completion, an average of 1 year
OS was the time from enrolment to death from any cause. OS was censored on the last date known to be alive for patients without documentation of death.
Through study completion, an average of 1 year
Disease-Free-Survival (DFS)
Time Frame: Through study completion, an average of 1 year
The time between the beginning of treatment and the observation of disease progression or death from any cause.
Through study completion, an average of 1 year
Number of participants with AEs (Adverse Events)
Time Frame: Through study completion, an average of 1 year
The AEs during the trial, including radiation mucositis, bone marrow suppression, AEs related to immunotherapy and so on. The AEs will be evaluated using the CTCAE 5.0 protocol.
Through study completion, an average of 1 year
Major pathologic response (MPR)
Time Frame: 10 days after operation
defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy
10 days after operation

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.
Wuhan Union Hospital, China

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.
March 30, 2021

Primary Completion (Estimated)

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 30, 2024

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 30, 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).
February 1, 2024

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 1, 2024

First Posted (Estimated)

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 9, 2024

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 9, 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 1, 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.
January 1, 2024

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.
  • 2018S00686

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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