A Phase 3 interventional study of Neoadjuvant immunochemotherapy in Esophageal Cancer, Surgery and Neoadjuvant Treatment, sponsored by Henan Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Henan Cancer Hospital · Phase 3, Interventional, and Treatment
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.
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.
Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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。
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)
Drug: Neoadjuvant immunochemotherapy
Neo-adjuvant chemotherapy(cisplatin and paclitaxel): Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 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).
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)
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.
Time frame: The date from the beginning of randomization to the date of first record. 3 years EFS
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.
Time frame: The date from the beginning of randomization to the date of first record. 5 years EFS
pCR
pathological complete response rate
Time frame: within 14 working days after operation
DFS
Disease free survival
Time frame: 3 years DFS
DFS
Disease free survival
Time frame: 5 years DFS
OS
Overall survival rate
Time frame: 3 years OS
OS
Overall survival rate
Time frame: 5 years OS
ORR
The Overall Response Rate. ORR=CR+PR. Criteria: Response Evaluation Criteria in Solid Tumors, RECIST.
Time frame: 3-4 weeks after the last cycle of neoadjuvant treatment
R0 resection rate
the complete resection rate of all tumor under microscope
Time frame: within 14 working days after operation
MPR
MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)
Time frame: within 14 working days after operation
EORTC QLQ-C30
EORTC QLQ-C30 repeated measurement model
Time frame: before surgery, 1month, 3 months, 6 months, 9 months, 1 year after operation
EORTC QLQ-OES18
EORTC QLQ-OES18 repeated measurement model
Time frame: before surgery, 1month, 3 months, 6 months, 9 months, 1 year after operation
NRS-2002
NRS-2002 repeated measurement model
Time frame: before surgery, 1month, 3 months, 6 months, 9 months, 1 year after operation
Plan to share: No — No plan
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Henan Cancer Hospital