CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 400 target
Drug / intervention
Neoadjuvant immunochemotherapydrug
Likely dose
Neoadjuvant immunochemotherapy 175mg/m2from record
Key inclusion· 8
  • ✓Histologically confirmed locally advanced squamous cell thoracic esophageal carcinoma Stage T1N1-3 or T2-3N0-3 M0 (UICC-TNM 8th edition)
  • ✓No metastatic cervical lymph nodes on imaging
  • ✓No prior anticancer therapy for esophageal carcinoma
  • ✓Age 18 to 75 years
Key exclusion· 16
  • ✕Multiple primary cancers
  • ✕Infections requiring treatment
  • ✕Continuous hormone treatment required
  • ✕Unstable angina within 3 months or myocardial infarction within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04280822
NCT04280822Phase 3RecruitingUpdate OverdueUpdated 44mo ago · Completion was 30mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

A Phase III, Randomized Controlled Study of Neo-adjuvant Toripalimab (JS001) in Combination With Chemotherapy Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

Henan Cancer Hospital·interventional·Posted Feb 21, 2020·Updated Oct 4, 2022

In Brief

A Phase 3 clinical trial evaluating Neoadjuvant immunochemotherapy for Esophageal Cancer and 3 related conditions. Currently recruiting, targeting 400 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer, Surgery, Neoadjuvant Treatment, Survival
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
202020212022202320242025202620272028
First PostedFeb 21, 2020
Enrollment StartApr 21, 2020
Primary CompletionDec 2, 2023
Study CompletionMar 2, 2028
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.4 years ago

Interventions

Neoadjuvant immunochemotherapydrug

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)