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.
Overview
- Phase
- Phase 1
- Intervention
- anti-PD-L1 antibody
- Conditions
- Esophageal Cancer
- Sponsor
- Lee's Pharmaceutical Limited
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- major pathologic response rate
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PD-L1 group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
Intervention: anti-PD-L1 antibody
PD-L1 group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
Intervention: albumin bound paclitaxel
PD-L1 group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
Intervention: cisplatin
PD-L1 group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
Intervention: radical resection of esophageal carcinoma
placebo group
All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
Intervention: albumin bound paclitaxel
placebo group
All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
Intervention: cisplatin
placebo group
All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
Intervention: placebo
placebo group
All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).
Intervention: radical resection of esophageal carcinoma
Outcomes
Primary Outcomes
major pathologic response rate
Time Frame: Two weeks after surgery.
The rate of pathologic 1a and 1b after neoadjuvant chemotherapy.
Secondary Outcomes
- overall survival rate(From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.)
- overall survival(From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.)
- R0 resection rate(Two weeks after surgery.)
- pathological complete response rate(Two weeks after surgery.)
- disease free survival(From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.)
- disease free survival rate(From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.)
- event free survival(From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.)
- event free survival rate(From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.)
- adverse events rate(From the date of randomization to 90 days after the last chemotherapy.)