Clinical trial NCT03985670: Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
Official title: Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Cell Carcinoma
Esophageal Cancer
Perioperative Period
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pathological complete response rate
timeFrame: two months
Secondary outcomes:
measure: occurrence rate of adverse events
timeFrame: three month
measure: disease-free survival rate
timeFrame: three years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Jing Ding, Master
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.