Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
No metastatic lymph node in cervical by color doppler sonography.
Patients must not have received any prior anticancer therapy of esophageal carcinoma.
Age ranges from 18 to 75 years.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Neoadjuvant immunochemotherapy
DrugNeo-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)
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Neoadjuvant immunochemotherapyExperimental treatment 1 intervention
Group B: Neoadjuvant chemotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 EFS2
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 EFSSecondary outcomes
1
pCR
pathological complete response rate
Time frame
within 14 working days after operation2
DFS
Disease free survival
Time frame
3 years DFS3
DFS
Disease free survival
Time frame
5 years DFS4
OS
Overall survival rate
Time frame
3 years OSSponsors and contacts
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Source ClinicalTrials.gov