Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedStudy Start
First participant enrolled
July 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedDecember 12, 2019
June 1, 2019
1.8 years
June 10, 2019
December 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Pathological complete response rate
the proportion of patients got pathological complete response rate
two months
Secondary Outcomes (2)
occurrence rate of adverse events
three month
disease-free survival rate
three years
Study Arms (2)
treatment group
EXPERIMENTALteripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1
chemotherapy followed by immunotherapy
ACTIVE COMPARATORpaclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3
Interventions
teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1
paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Related Publications (2)
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.
PMID: 34938292DERIVEDXing 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.
PMID: 33282388DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Ding, Master
Henan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2019
First Posted
June 14, 2019
Study Start
July 10, 2019
Primary Completion
April 30, 2021
Study Completion
April 30, 2023
Last Updated
December 12, 2019
Record last verified: 2019-06