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出境医 / 临床实验 / Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Squamous Cell Carcinoma Esophageal Cancer Perioperative Period | Drug: teripalimab plus chemotherapy Drug: chemotherapy plus teripalimab | Phase 2 |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| Official Title: | Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer |
| Actual Study Start Date : | July 10, 2019 |
| Estimated Primary Completion Date : | April 30, 2021 |
| Estimated Study Completion Date : | April 30, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: treatment group
teripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1
|
Drug: teripalimab plus chemotherapy
teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1
Other Name: teripalimab and chemotherapy given on the same day
|
|
Active Comparator: chemotherapy followed by immunotherapy
paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3
|
Drug: chemotherapy plus teripalimab
paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3
Other Name: chemotherapy followed by teripalimab
|
Outcome Measures
Primary Outcome Measures :
- Pathological complete response rate [ Time Frame: two months ]the proportion of patients got pathological complete response rate
Secondary Outcome Measures :
- occurrence rate of adverse events [ Time Frame: three month ]the occurrence of adverse events
- disease-free survival rate [ Time Frame: three years ]the proportion of patients without relapse
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Quanli Gao, Dr. | +86-15038171966 | gaoquanli2015@126.com | |
| Contact: Lingdi Zhao, Dr. | +86-371-65587483 | lingdizhao@126.com |
Locations
| China, Henan | |
| Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital | Recruiting |
| Zhengzhou, Henan, China, 450008 | |
| Contact: Quanli Gao, M.D +86-371-65587795 gaoquanli2015@126.com | |
| Contact: Lingdi Zhao, M.D. +86-371-65587483 lingdizhao@126.com | |
Sponsors and Collaborators
Henan Cancer Hospital
Investigators
| Principal Investigator: | Jing Ding, Master | Henan Cancer Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 10, 2019 | ||||||||
| First Posted Date ICMJE | June 14, 2019 | ||||||||
| Last Update Posted Date | December 12, 2019 | ||||||||
| Actual Study Start Date ICMJE | July 10, 2019 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pathological complete response rate [ Time Frame: two months ] the proportion of patients got pathological complete response rate
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer | ||||||||
| Official Title ICMJE | Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention 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)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
30 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 30, 2023 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03985670 | ||||||||
| Other Study ID Numbers ICMJE | HenanCH immunotherapy001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Henan Cancer Hospital | ||||||||
| Study Sponsor ICMJE | Henan Cancer Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Henan Cancer Hospital | ||||||||
| Verification Date | June 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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