Back to resultsCombination of Chemotherapy Plus RT and SHR-1210 to Treat Patients With ESCC
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SHR-1210
IMRT or VMAT
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, SHR-1210, Apatinib
Eligibility Criteria
Inclusion Criteria:
- age:18-75 years, male or female.
- Histologically confirmed primary Squamous Cell Carcinoma of the Esophagus,Local advanced esophageal cancer diagnosed by pathology and imaging,clinical stage T3-4N0M0, T1-4N+M0,Ⅱ-Ⅳa.
- Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- ECOG 0-1.
- Adequate organ function.
- Life expectancy of greater than 6 months.
- Patient has given written informed consent.
Exclusion Criteria:
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
- Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
Subjects with any active autoimmune disease or history of autoimmune disease
- Page 4 of 4 [DRAFT] -
- Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Pregnancy or breast feeding.
- Decision of unsuitableness by principal investigator or physician-incharge.
Sites / Locations
- Department of Radiation Oncology, Tianjin Medical University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-1210 + Chemotherapy + Radiotherapy
Arm Description
Radiotherapy(IMRT or VMAT): 95%PTV 54Gy/30 fraction,95%PTV 60Gy/30 fraction ,5 fractions per week, for 6 weeks. Radiation begun the day on which first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks, one cycle is four weeks, total 8 cycles ) will be administered as an intravenous infusion over 30 minutes. Chemotherapy: Docetaxel 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22, total 4 cycles; Cisplatin 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22;, total 4 cycles. Apatinib: 250mg/d，PO Qd(4 weeks after Radiotherapy, until the end of 8th ycle )
Outcomes
Primary Outcome Measures
Adverse events (AE), Serious Adverse Event(SAE) Adverse events
Incidence of Treatment-Emergent Adverse Events
Secondary Outcome Measures
ORR
Objective Response Rate
PFS
Progression-Free Survival
OS
overall survival
Full Information
NCT ID
NCT03671265
First Posted
September 2, 2018
Last Updated
January 7, 2019
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03671265
Brief Title
Combination of Chemotherapy Plus RT and SHR-1210 to Treat Patients With ESCC
Official Title
A Single Arm Exploratory Study of Chemotherapy Plus Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Locally Advanced Esophageal Squamous Cell Carcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an openlabel，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 and chemotherapy in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal Cancer, Concurrent chemoradiation, Immunotherapy, SHR-1210, Apatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1210 + Chemotherapy + Radiotherapy
Arm Type
Experimental
Arm Description
Radiotherapy(IMRT or VMAT): 95%PTV 54Gy/30 fraction,95%PTV 60Gy/30 fraction ,5 fractions per week, for 6 weeks. Radiation begun the day on which first dose of SHR-1210.
SHR-1210 (200mg fixed dose every 2 weeks, one cycle is four weeks, total 8 cycles ) will be administered as an intravenous infusion over 30 minutes.
Chemotherapy: Docetaxel 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22, total 4 cycles; Cisplatin 25mg/m2/w, intravenous infusion on days 1, 8, 15, 22;, total 4 cycles.
Apatinib: 250mg/d，PO Qd(4 weeks after Radiotherapy, until the end of 8th ycle )
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Other Intervention Name(s)
Anti-PD-1 Antibody
Intervention Description
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Intervention Type
Radiation
Intervention Name(s)
IMRT or VMAT
Intervention Description
The IMRT or VMAT technique was used in our study.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib is a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2.
Primary Outcome Measure Information:
Title
Adverse events (AE), Serious Adverse Event(SAE) Adverse events
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
Through study completion, an average of half a year]
Secondary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
Through study completion, an average of 1 year
Title
PFS
Description
Progression-Free Survival
Time Frame
1year and 3years
Title
OS
Description
overall survival
Time Frame
1year and 3years
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:18-75 years, male or female.
Histologically confirmed primary Squamous Cell Carcinoma of the Esophagus,Local advanced esophageal cancer diagnosed by pathology and imaging,clinical stage T3-4N0M0, T1-4N+M0,Ⅱ-Ⅳa.
Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
ECOG 0-1.
Adequate organ function.
Life expectancy of greater than 6 months.
Patient has given written informed consent.
Exclusion Criteria:
Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
Subjects with any active autoimmune disease or history of autoimmune disease
- Page 4 of 4 [DRAFT] -
Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
Received a live vaccine within 4 weeks of the first dose of study medication.
Pregnancy or breast feeding.
Decision of unsuitableness by principal investigator or physician-incharge.
Facility Information:
Facility Name
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Wang, M. D.
Phone
08623340123-1121
Email
wangping@tjmuch.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
35046943
Citation
Ma X, Guo Z, Wei X, Zhao G, Han D, Zhang T, Chen X, Cao F, Dong J, Zhao L, Yuan Z, Wang P, Pang Q, Yan C, Zhang W. Spatial Distribution and Predictive Significance of Dendritic Cells and Macrophages in Esophageal Cancer Treated With Combined Chemoradiotherapy and PD-1 Blockade. Front Immunol. 2022 Jan 3;12:786429. doi: 10.3389/fimmu.2021.786429. eCollection 2021.
Results Reference
derived
PubMed Identifier
34616588
Citation
Zhang W, Yan C, Zhang T, Chen X, Dong J, Zhao J, Han D, Wang J, Zhao G, Cao F, Zhou D, Jiang H, Tang P, Zhao L, Yuan Z, Wang Q, Wang P, Pang Q. Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study. Oncoimmunology. 2021 Sep 28;10(1):1971418. doi: 10.1080/2162402X.2021.1971418. eCollection 2021.
Results Reference
derived
Learn more about this trial
Combination of Chemotherapy Plus RT and SHR-1210 to Treat Patients With ESCC
We'll reach out to this number within 24 hrs