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

Who is this study for? Patients with Esophageal Cancer
What treatments are being studied? Neoadjuvant Immunochemotherapy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• Without operative contraindication.

• 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.

• 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).

• expected R0 resection.

• ECOG 0~1.

⁃ 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.

⁃ Signed informed consent document on file. 10. .

Locations
Other Locations
China
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
RECRUITING
Zhengzhou
Contact Information
Primary
Yan Zheng, PhD, MD
sunnyzheng1@126.com
+86+15713660065
Backup
Haibo Sun, PhD, MD
sunny-haipo@hotmail.com
Time Frame
Start Date: 2020-04-21
Estimated Completion Date: 2028-03-02
Participants
Target number of participants: 400
Treatments
Experimental: 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)
Active_comparator: Neoadjuvant chemotherapy
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).
Related Therapeutic Areas
Sponsors
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov