Back to resultsTeripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
Primary Purpose
Squamous Cell Carcinoma, Esophageal Cancer, Perioperative Period
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
teripalimab plus chemotherapy
chemotherapy plus teripalimab
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Thoracic esophageal squamous cell carcinoma diagnosed by pathology
- no distant metastasis, the diseases could be resected or potentially resectable assessed by thoracic oncologist
- ECOG score 0-1
- clinical stage is stage II, III, and IVa according to AJCC 8.0
- expected lifespan > 3 months
- enough organ function
- normal blood pressure, for patients with hypertension, the blood pressure should be controlled in normal level by antihypertension
- the fasting blood sugar should be ≤ 8mmol / L for diabetic patients
- no other serious diseases (such as autoimmune diseases, immunodeficiencies, organ transplants) that conflict with this study
- no history of other malignant tumors
- women of childbearing period must be tested negative for blood pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial period and within 6 months after the trial;
- The patient agrees to participate in the clinical study and sign the Informed Consent Form.
Exclusion Criteria:
- suffering from serious infectious diseases within 4 weeks before enrollment;
- patients with bronchial asthma requires intermittent use of bronchodilators or medical interventions;
- usage of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks
- clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, and room requiring medical intervention within the first 6 months of enrollment arrhythmia, left ventricular ejection fraction <50%
- severe allergies
- severe mental disorder
- abnormal blood coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), bleeding tendency or receiving thrombolysis or anticoagulant therapy
- previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc
- other situations evaluated by investigators not meet the enrollment
Sites / Locations
- Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
treatment group
chemotherapy followed by immunotherapy
Arm Description
teripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1
paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3
Outcomes
Primary Outcome Measures
Pathological complete response rate
the proportion of patients got pathological complete response rate
Secondary Outcome Measures
occurrence rate of adverse events
the occurrence of adverse events
disease-free survival rate
the proportion of patients without relapse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03985670
Brief Title
Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
Official Title
Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital
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 prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the pathological complete response rate in NSCLC, however, the data in neoadjuvant of esophageal squamous carcinoma is relatively rare. This study was designed to know the value of PD-1 antibody in neoadjuvant therapy of esophageal cancer.
Detailed Description
The prognosis of locally advanced esophageal squamous cell carcinoma is poor, the 5-year survival rate is less than 50%. It is necessary to conduct studies in these patients to reduce the rate of postoperative recurrence and prolong the disease-free survival. The role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer. The PD-1 antibody, teripalimab, is an immunological checkpoint inhibitor that has shown clinical efficacy in advanced esophageal cancer, but there has been relatively few data on neoadjuvant therapy. This study was designed to comprehend the pathological complete response rate, disease-free survival, and safety of neoadjuvant therapy with chemotherapy plus teriprilin patients with locally advanced esophageal squamous cell carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma, Esophageal Cancer, Perioperative Period
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
patients with local advanced esophageal squamous cell carcinoma receive two cycle of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody, and then surgery
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
teripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1
Arm Title
chemotherapy followed by immunotherapy
Arm Type
Active Comparator
Arm Description
paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3
Intervention Type
Drug
Intervention Name(s)
teripalimab plus chemotherapy
Other Intervention Name(s)
teripalimab and chemotherapy given on the same day
Intervention Description
teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1
Intervention Type
Drug
Intervention Name(s)
chemotherapy plus teripalimab
Other Intervention Name(s)
chemotherapy followed by teripalimab
Intervention Description
paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3
Primary Outcome Measure Information:
Title
Pathological complete response rate
Description
the proportion of patients got pathological complete response rate
Time Frame
two months
Secondary Outcome Measure Information:
Title
occurrence rate of adverse events
Description
the occurrence of adverse events
Time Frame
three month
Title
disease-free survival rate
Description
the proportion of patients without relapse
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Thoracic esophageal squamous cell carcinoma diagnosed by pathology
no distant metastasis, the diseases could be resected or potentially resectable assessed by thoracic oncologist
ECOG score 0-1
clinical stage is stage II, III, and IVa according to AJCC 8.0
expected lifespan > 3 months
enough organ function
normal blood pressure, for patients with hypertension, the blood pressure should be controlled in normal level by antihypertension
the fasting blood sugar should be ≤ 8mmol / L for diabetic patients
no other serious diseases (such as autoimmune diseases, immunodeficiencies, organ transplants) that conflict with this study
no history of other malignant tumors
women of childbearing period must be tested negative for blood pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial period and within 6 months after the trial;
The patient agrees to participate in the clinical study and sign the Informed Consent Form.
Exclusion Criteria:
suffering from serious infectious diseases within 4 weeks before enrollment;
patients with bronchial asthma requires intermittent use of bronchodilators or medical interventions;
usage of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks
clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, and room requiring medical intervention within the first 6 months of enrollment arrhythmia, left ventricular ejection fraction <50%
severe allergies
severe mental disorder
abnormal blood coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), bleeding tendency or receiving thrombolysis or anticoagulant therapy
previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc
other situations evaluated by investigators not meet the enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quanli Gao, Dr.
Phone
+86-15038171966
Email
gaoquanli2015@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lingdi Zhao, Dr.
Phone
+86-371-65587483
Email
lingdizhao@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Ding, Master
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quanli Gao, M.D
Phone
+86-371-65587795
Email
gaoquanli2015@126.com
First Name & Middle Initial & Last Name & Degree
Lingdi Zhao, M.D.
Phone
+86-371-65587483
Email
lingdizhao@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34938292
Citation
Xing W, Zhao L, Zheng Y, Liu B, Liu X, Li T, Zhang Y, Ma B, Yang Y, Shang Y, Fu X, Liang G, Yuan D, Qu J, Chai X, Zhang H, Wang Z, Lin H, Liu L, Ren X, Zhang J, Gao Q. The Sequence of Chemotherapy and Toripalimab Might Influence the Efficacy of Neoadjuvant Chemoimmunotherapy in Locally Advanced Esophageal Squamous Cell Cancer-A Phase II Study. Front Immunol. 2021 Dec 6;12:772450. doi: 10.3389/fimmu.2021.772450. eCollection 2021.
Results Reference
derived
PubMed Identifier
33282388
Citation
Xing W, Zhao L, Fu X, Liang G, Zhang Y, Yuan D, Li Z, Gao Q, Zheng Y; written on Henan Cancer Hospital Thoracic Oncology Group (HCHTOG). A phase II, single-centre trial of neoadjuvant toripalimab plus chemotherapy in locally advanced esophageal squamous cell carcinoma. J Thorac Dis. 2020 Nov;12(11):6861-6867. doi: 10.21037/jtd-20-2198.
Results Reference
derived
Learn more about this trial
Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
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