NCT04460066

A Study of Anti-PD-L1 Antibody in Neoadjuvant Chemotherapy of Esophageal Squamous Cell Carcinoma.

A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Study of Anti-pd-l1 Monoclonal Antibody Injection (ZKAB001) Combined Albumin Binding Paclitaxel, Cisplatin in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled Ib/Ⅱ clinical study to evaluate the safety and effect of anti-PD-L1 antibody (ZKAB001) in neoadjuvant chemotherapy of esophageal squamous carcinoma in combination with Alb-paclitaxel and cisplatin. The immunotherapy will be given before and after the operation every three weeks.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	anti-PD-L1 antibody	Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
DRUG	albumin bound paclitaxel	Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .
DRUG	cisplatin	Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.
DRUG	placebo	Patients will receive 4 cycles of placebo IV on day 1 every 3 weeks.
PROCEDURE	radical resection of esophageal carcinoma	Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.

Timeline

• Start date: 2020-11-18
• Primary completion: 2021-12-06
• Completion: 2023-07-15
• First posted: 2020-07-07
• Last updated: 2022-05-04

Locations

1 site across 1 country: China