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
About this trial
This is an interventional treatment trial for SHR-1210
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.
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
NCT ID
NCT04797507
First Posted
February 25, 2021
Last Updated
March 11, 2021
Sponsor
Peking Union Medical College Hospital
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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SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer
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