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SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer

Primary Purpose

SHR-1210, Anlotinib, Advanced Esophageal Squamous Cell Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1210 plus Anlotinib
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SHR-1210

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age:18 years to 75 years, male or female.
  2. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease.
  3. Progressed after first-line chemotherapy.
  4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  5. Newly acquired or archived tumor tissue samples can be obtained.
  6. Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1
  7. Life expectancy >12 weeks.
  8. Adequate organ function.
  9. For females of child bearing potential, a negative urine or serum pregnancy test result within 1 week before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study until 4 months after the last dose of any of the drugs in the study.
  10. Willing and able to follow the study protocol and follow-up procedures for treatment and follow-up.
  11. Willing and able to provide written informed consent.

Exclusion Criteria:

Patients should not be selected for this clinical study if they have any of the following conditions:

  1. Abnormal coagulation function , with bleeding tendency or receiving thrombolytic or anticoagulant therapy. Note: Low-dose heparin (60,000-12,000 U/day for adults) or low-dose aspirin (≤100mg/day) are permitted for prophylactic purposes if INR≤1.5.
  2. The arterial/venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, pulmonary embolism, etc, occurred within 6 months before administration.
  3. Clinically significant hemoptysis occurred within 3 months before medication (hemoptysis > 50ml per day); Or clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis, etc.
  4. Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
  5. Received systemic steroid therapy within 3 days of the first dose of study medication.
  6. Received a live vaccine within 4 weeks of the first dose of study medication.
  7. Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
  8. Imaging (CT or MRI) showed that the distance of the tumor lesion from great vessels was less than 5 mm, or invasion of local great vessels, or central tumor with high blood risk; Or there is obvious lung cavity or necrotizing tumor. Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease.
  9. Pregnant or lactating female.
  10. Participate in other clinical trials currently or within 4 weeks prior to enrollment.
  11. Receiving other anti-cancer drugs (including anti-cancer traditional chinese medicine).
  12. Familial, sociological or geographical conditions that, in the clinical judgment of the Principal Investigator, do not permit compliance with the protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment Group

    Arm Description

    SHR-1210 plus Anlotinib

    Outcomes

    Primary Outcome Measures

    ORR based on RECIST v1.1
    Objective response rate based on RECIST v1.1 by investigators

    Secondary Outcome Measures

    DCR based on RECIST v1.1
    Disease control rate based on RECIST v1.1 by investigators
    Overall survival
    Overall survival based on RECIST v1.1 by investigators
    Progression free survival
    Progression free survival based on RECIST v1.1 by investigators
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Safety and tolerance by investigators

    Full Information

    First Posted
    February 25, 2021
    Last Updated
    March 11, 2021
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04797507
    Brief Title
    SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer
    Official Title
    SHR-1210, a Novel Anti-PD-1 Antibody, in Combination With Anlotinib As Second-line or Above Treatment in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer: a Phase II Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study was designed to explore the clinical efficacy of SHR-1210 in combined with Anlotinib in the treatment of second- or above- line advanced or metastatic esophageal squamous cell cancer patients, in order to find a better therapy strategy for esophageal squamous cell cancer patients.
    Detailed Description
    This is a prospective, phase II, single-arm clinical trial. Advanced or metastatic esophageal squamous cell cancer(ESCC) patients progressed after 1st systematic treatment are treated with SHR-1210 and Anlotinib. SHR-1210 was given intravenously(200mg d1 Q2w), combined with Anlotinib orally, 12 mg d1-14 Q3w. The hypothesis: The objective response rate in SHR-1210 combined with Anlotinib can reach 40% as second-line or above treatment of advanced or metastatic ESCC patients. The primary endpoint is objective response rate (ORR) and the secondary endpoint is disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and safety of this regimen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SHR-1210, Anlotinib, Advanced Esophageal Squamous Cell Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    33 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    SHR-1210 plus Anlotinib
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1210 plus Anlotinib
    Intervention Description
    SHR-1210: a novel anti-PD-1 antibody Anlotinib: a multi-kinase inhibitor
    Primary Outcome Measure Information:
    Title
    ORR based on RECIST v1.1
    Description
    Objective response rate based on RECIST v1.1 by investigators
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    DCR based on RECIST v1.1
    Description
    Disease control rate based on RECIST v1.1 by investigators
    Time Frame
    12 months
    Title
    Overall survival
    Description
    Overall survival based on RECIST v1.1 by investigators
    Time Frame
    24 months
    Title
    Progression free survival
    Description
    Progression free survival based on RECIST v1.1 by investigators
    Time Frame
    12 months
    Title
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Description
    Safety and tolerance by investigators
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age:18 years to 75 years, male or female. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease. Progressed after first-line chemotherapy. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Newly acquired or archived tumor tissue samples can be obtained. Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1 Life expectancy >12 weeks. Adequate organ function. For females of child bearing potential, a negative urine or serum pregnancy test result within 1 week before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study until 4 months after the last dose of any of the drugs in the study. Willing and able to follow the study protocol and follow-up procedures for treatment and follow-up. Willing and able to provide written informed consent. Exclusion Criteria: Patients should not be selected for this clinical study if they have any of the following conditions: Abnormal coagulation function , with bleeding tendency or receiving thrombolytic or anticoagulant therapy. Note: Low-dose heparin (60,000-12,000 U/day for adults) or low-dose aspirin (≤100mg/day) are permitted for prophylactic purposes if INR≤1.5. The arterial/venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, pulmonary embolism, etc, occurred within 6 months before administration. Clinically significant hemoptysis occurred within 3 months before medication (hemoptysis > 50ml per day); Or clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis, etc. Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease. Received systemic steroid therapy within 3 days of the first dose of study medication. Received a live vaccine within 4 weeks of the first dose of study medication. Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication. Imaging (CT or MRI) showed that the distance of the tumor lesion from great vessels was less than 5 mm, or invasion of local great vessels, or central tumor with high blood risk; Or there is obvious lung cavity or necrotizing tumor. Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease. Pregnant or lactating female. Participate in other clinical trials currently or within 4 weeks prior to enrollment. Receiving other anti-cancer drugs (including anti-cancer traditional chinese medicine). Familial, sociological or geographical conditions that, in the clinical judgment of the Principal Investigator, do not permit compliance with the protocol.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junjie Gu, Doctor
    Phone
    86-10-69158773
    Email
    gujunjie_ella@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chunmei Bai, Doctor
    Phone
    86-10-69158773
    Email
    baichunmei1964@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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