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

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Sponsored by
The First Affiliated Hospital of Zhengzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Advanced or metastatic esophageal squamous cell cancer(ESCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Camrelizumab

Camrelizumab plus chemotherapy

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

DOR
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.

Secondary Outcome Measures

PFS
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.
OS
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.
ORR
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.

Full Information

First Posted
November 19, 2020
Last Updated
August 20, 2021
Sponsor
The First Affiliated Hospital of Zhengzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT04654403
Brief Title
Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell Cancer
Official Title
Phase II Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Advanced or metastatic esophageal squamous cell cancer(ESCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
337 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab
Arm Type
Experimental
Arm Description
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)
Arm Title
Camrelizumab plus chemotherapy
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Other Intervention Name(s)
SHR-1210
Intervention Description
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).
Primary Outcome Measure Information:
Title
DOR
Description
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.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
PFS
Description
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.
Time Frame
Up to 12 months
Title
OS
Description
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.
Time Frame
Up to 24 months
Title
ORR
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Wang, Doctor
Phone
13938244776
Email
fengw010@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangrui Meng, Doctor
Phone
15890166919
Email
mengxiangruibb2008@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Wang, Doctor
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Wang, Doctor
Phone
13938244776
Email
fengw010@163.com
First Name & Middle Initial & Last Name & Degree
Xiangrui Meng, Doctor
Phone
15890166919
Email
mengxiangruibb2008@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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