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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04280822
Other study ID # HCHTOG1909
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 21, 2020
Est. completion date March 2, 2028

Study information

Verified date October 2022
Source Henan Cancer Hospital
Contact Yan Zheng, PhD, MD
Phone +86+15713660065
Email sunnyzheng1@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The effect of neo-adjuvant immunochemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains unknown. One of our objectives is to evaluate whether the neo-adjuvant immunochemotherapy Toripalimab (JS001) with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients versus neo-adjuvant chemotherapy.


Description:

The effect of immunochemotherapy in second line treatment of esophageal cancer got a positive results in the world. We tried to apply the immunotheray in resectable esophageal cancer and have planed this phase III clinical trials. The optimal management of resectable esophageal squamous cell carcinomas may have a new chapter in the era of immunotherapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date March 2, 2028
Est. primary completion date December 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Histologic diagnosis of local advance squamous cell thoracic esophageal carcinoma of Stage (T1N1-3 or T2-3N0-3 M0), (8th Union for International Cancer Control, UICC-TNM). 2. No metastatic lymph node in cervical by color doppler sonography. 3. Patients must not have received any prior anticancer therapy of esophageal carcinoma. 4. Age ranges from 18 to 75 years. 5. Without operative contraindication. 6. Absolute white blood cells count =4.0×109/L, neutrophil =1.5×109/L, platelets =100.0×109/L, hemoglobin =90g/L, and normal functions of liver and kidney, total bilirubin(TBIL)=1.5N, aspartate aminotransferase (AST)=2.5N, alanine aminotransferase(ALT)=2.5N, prothrombin time(PT)=1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)=1.5N. 7. Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS). 8. expected R0 resection. 9. ECOG 0~1. 10. Patients should agree to use contraceptive measures during the study period and within 6 months of the end of the study. Women must be non-lactation. 11. Signed informed consent document on file. 10. . Exclusion Criteria: - 1. Multiple primary cancer. 2.Patients with infections disease that require treatment 3.Patients who need continuous hormone treatment 4.unstable angina within 3 months, myocardial infarction within 6 months 5.psychopath 6.Patients with concomitant hemorrhagic disease. 7.Any unexpected reason for patients can't get operation 8.Inability to use gastric conduit after esophagectomy because of a prior surgery. 9.Pregnant or breast feeding 10.Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel. 11.Bronchial asthma who requires intermittent use of bronchodilators or medical interventions 12.Due to co-existing diseases, the immunosuppressant was used. And the dosage of immunosuppressant was more than 10mg/ day orally and more than 2 weeks before enrollment 13.Abnormal coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), tendency of bleeding or receiving thrombolysis or anticoagulant therapy 14.Previous or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, lung function severely impaired 15.Autoimmune diseases, immune deficiency, organ transplantation; 16.Hepatitis b/c patients?

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Neoadjuvant immunochemotherapy
Neo-adjuvant chemotherapy(cisplatin and paclitaxel): Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles. JS001, 240mg ivgtt, d3, >30min, 3week, 2 cycles Surgery: 2-3weeks after Neo-adjuvant chemotherapy Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included). After surgery/ maintain period: JS001, 240mg ivgtt, d3, >30min, 3week (8 cycles at most)

Locations

Country Name City State
China Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University) Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event-free survival (EFS) The date from the beginning of randomization to the date of first record of unresectable disease, distant metastases, local recurrences of any causes, and death of any cause. The date from the beginning of randomization to the date of first record. 3 years EFS
Primary Event-free survival (EFS) The date from the beginning of randomization to the date of first record of unresectable disease, distant metastases, local recurrences of any causes, and death of any cause. The date from the beginning of randomization to the date of first record. 5 years EFS
Secondary pCR pathological complete response rate within 14 working days after operation
Secondary DFS Disease free survival 3 years DFS
Secondary DFS Disease free survival 5 years DFS
Secondary OS Overall survival rate 3 years OS
Secondary OS Overall survival rate 5 years OS
Secondary ORR The Overall Response Rate. ORR=CR+PR. Criteria: Response Evaluation Criteria in Solid Tumors, RECIST. 3-4 weeks after the last cycle of neoadjuvant treatment
Secondary R0 resection rate the complete resection rate of all tumor under microscope within 14 working days after operation
Secondary MPR MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor =10%) within 14 working days after operation
Secondary EORTC QLQ-C30 EORTC QLQ-C30 repeated measurement model before surgery, 1month, 3 months, 6 months, 9 months, 1 year after operation
Secondary EORTC QLQ-OES18 EORTC QLQ-OES18 repeated measurement model before surgery, 1month, 3 months, 6 months, 9 months, 1 year after operation
Secondary NRS-2002 NRS-2002 repeated measurement model before surgery, 1month, 3 months, 6 months, 9 months, 1 year after operation
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