Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell Cancer

August 20, 2021 updated by: Feng Wang, The First Affiliated Hospital of Zhengzhou University

Phase II Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell Cancer

The purpose of this study is to evaluate the efficacy and safety of Camrelizumab or Camrelizumab plus chemotherapy in patients with untreated, advanced ESCC with PD-L1 CPS≥10 ,who have been achieved PR and CR after treated with Camrelizumab.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

Standard 1L chemotherapy for advanced or metastatic esophageal squamous cell cancer(ESCC) results in poor OS(median<1year).Camrelizumab provided superior OS versus chemotherapy in heavily pretreated advanced/rucurrent ESCC.PD-1 antibody +chemo showed promisng antitumor activity in 1L advanced or metastatic ESCC.PD-L1 expression by CPS at cutoff≥10 has shown better enrichment for efficacy fo checkpoint inhibitors in ESCC.Recently, two clinical trials on Pembrolizumb have attracted our attention,KEYNOTE-181 and KEYNOTE-590.The median duration of response was 9.3 months in pembrolizumab monotherapy (KEYNOTE-181) ,and 8.3 months in Pembrolizumb plus chemotherapy (KEYNOTE-590). We hypothesis that administration of the PD-1 inhibitor will significantly prolong survival compared to PD-1 inhibitor combined with chemotherapy, when used as maintenance therapy in patients sensitive to PD-1 inhibitors.

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.
337

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 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
    • Henan
      • Zhengzhou, Henan, China, 450000
        • The First Affiliated Hospital of Zhengzhou 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Male or female

    • Age ≥18 years
    • Histologically or cytologically confirmed locally advanced unresectable or metastatic ESCC
    • Measurable disease per RECIST v1.1 assessed by the local investigator
    • ECOG performance status 0 or 1
    • Provide newly obtained (preferred) or archival tissue sample
    • Negative urine or serum pregnancy test within 72 h before randomization (females)
    • Willing to use an adequate method of contraception throughout the study and for 120 days after the last dose of study medication and up to 180 days after the last dose of cisplatin
    • Adequate hematologic function, defined as ANC ≥ 1500/μl,platelet count ≥ 100,000/μl and hemoglobin ≥ 9.0 g/dl or ≥5.6 mmol/l
    • Adequate renal function, defined as creatinine ≤ 1.5 × ULN or measured or calculated creatinine clearance ≥ 60 mL/min for those with creatinine levels 1.5 × ULN
    • Adequate hepatic function, defined as total bilirubin ≤1.5 × ULN, or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN, and ALT/AST levels ≤ 2.5 × ULN
    • Adequate coagulation function, defined as INR ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range
    • Written informed consent

Exclusion Criteria:

  • • Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator

    • Previous therapy for advanced disease
    • Major surgery, open biopsy or significant traumatic injury within 28 days before randomization or anticipated need for major surgery during the study treatment period
    • Known additional malignancy that is progressing or requires active treatment (except for BCC or SCC of the skin, in situ cervical cancer, in situ breast cancer that has undergone potentially curative treatment and in situ or intramucosal pharyngeal cancer)
    • Known active CNS metastases and/or carcinomatous meningitis; patients with previously treated and radiologically stable brain metastases may be eligible
    • Active autoimmune disease that has necessitated systemic treatment (other than replacement therapy) in the past 2 years
    • Diagnosis of immunodeficiency, receiving chronic systemic steroid therapy 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment or history of organ transplant including allogeneic stem cell transplant
    • Active infection necessitating systemic therapy
    • History or current evidence of any condition, therapy or laboratory abnormality that might confound the study results or interfere with study participation

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: Randomized
  • Interventional Model: Parallel 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
Camrelizumab (200 mg every 2 weeks),Treatment will continue until confirmed radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, nonadherence to treatment or trial procedures or completion of 16 cycles of Camrelizumab (approximately 1 years)
Drug: Camrelizumab
Eligible patients receive Camrelizumab 200 mg by intravenous (iv.) infusion every 2 weeks (Q2W) for 4 cycles.Imaging will be performed 2-3 weeks after the 4th Camrelizumab administration.Patients who achieve PD and SD will be not included in the data statistics of this trial.The follow-up treatment according to investigator's and patients's choice(chemotherapy, Camrelizumab plus chemotherapy or Camrelizumab monotherapy).Other patients whose BOR is in remission (CR+PR) will be randomly assigned in a 1:1 ratio to receive Camrelizumab (200 mg every 2 weeks), or Camrelizumab plus chemotherapy(Camrelizumab 200 mg every 3 weeks,docetaxel 75mg/m2/d plus cisplatin 75 mg/m2/d on day 1 every 3 weeks),)Treatment will continue until confirmed radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, nonadherence to treatment or trial procedures or completion of 16 cycles of Camrelizumab (approximately 1 years).
Other Names:
  • SHR-1210
Active Comparator: Camrelizumab plus chemotherapy
Camrelizumab plus chemotherapy(Camrelizumab 200 mg every 3 weeks,docetaxel 75mg/m2/d plus cisplatin 75 mg/m2/d on day 1 every 3 weeks),)Treatment will continue until confirmed radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, nonadherence to treatment or trial procedures or completion of 16 cycles of Camrelizumab (approximately 1 years).
Drug: Camrelizumab
Eligible patients receive Camrelizumab 200 mg by intravenous (iv.) infusion every 2 weeks (Q2W) for 4 cycles.Imaging will be performed 2-3 weeks after the 4th Camrelizumab administration.Patients who achieve PD and SD will be not included in the data statistics of this trial.The follow-up treatment according to investigator's and patients's choice(chemotherapy, Camrelizumab plus chemotherapy or Camrelizumab monotherapy).Other patients whose BOR is in remission (CR+PR) will be randomly assigned in a 1:1 ratio to receive Camrelizumab (200 mg every 2 weeks), or Camrelizumab plus chemotherapy(Camrelizumab 200 mg every 3 weeks,docetaxel 75mg/m2/d plus cisplatin 75 mg/m2/d on day 1 every 3 weeks),)Treatment will continue until confirmed radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, nonadherence to treatment or trial procedures or completion of 16 cycles of Camrelizumab (approximately 1 years).
Other Names:
  • SHR-1210

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
DOR
Time Frame: Up to 12 months
DOR was defined as the time from the first documented a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) to progressive disease (PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD) as assessed using RECIST v1.1.Median DOR as assessed by blinded independent central review per RECIST 1.1 is presented for participants who receive Camrelizumab with or without chemotherapy for advanced esophageal squamous cell cancer with a PD-L1 CPS ≥10.
Up to 12 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
PFS
Time Frame: Up to 12 months
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants who receive Camrelizumab with or without chemotherapy for advanced esophageal squamous cell cancer with a PD-L1 CPS ≥10.
Up to 12 months
OS
Time Frame: Up to 24 months
OS was defined as the time from randomization to death due to any cause. Median OS in participants who receive Camrelizumab with or without chemotherapy for advanced esophageal squamous cell cancer with a PD-L1 CPS ≥10.
Up to 24 months
ORR
Time Frame: Up to 12 months
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants with SCC of the esophagus who experienced a CR or PR is presented.
Up to 12 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.
The First Affiliated Hospital of Zhengzhou 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 (Anticipated)

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.
January 1, 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.
May 31, 2022

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, 2022

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 19, 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 3, 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 4, 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.
August 23, 2021

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.
August 20, 2021

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.
August 1, 2021

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.
  • SHR1210-016

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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