Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer

Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Squamous Cell Carcinoma; Perioperative Period
• Intervention / Treatment: Drug: teripalimab plus chemotherapy; Drug: chemotherapy plus teripalimab

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: chemotherapy followed by teripalimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response rate	the proportion of patients got pathological complete response rate	two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence rate of adverse events	the occurrence of adverse events	three month
disease-free survival rate	the proportion of patients without relapse	three years

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: HenanCH immunotherapy001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No