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

Phase 1

• Conditions: Esophageal Cancer
• Interventions: Drug: anti-PD-L1 antibody; Drug: albumin bound paclitaxel; Drug: placebo; Drug: cisplatin; Procedure: radical resection of esophageal carcinoma

• Registration Number: NCT04460066
• Lead Sponsor: Lee's Pharmaceutical Limited

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-05
• Study First Posted: 2020-07-07
• Study Start: 2020-11-18
• Primary Completion: 2021-12-06
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-05-04
• Study Completion: 2023-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD-L1 group	radical resection of esophageal carcinoma	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).
placebo group	placebo	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).
placebo group	radical resection of esophageal carcinoma	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).
PD-L1 group	anti-PD-L1 antibody	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).
PD-L1 group	albumin bound paclitaxel	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).
PD-L1 group	cisplatin	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).
placebo group	cisplatin	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).
placebo group	albumin bound paclitaxel	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).

Primary Outcome Measures

Name	Time	Method
major pathologic response rate	Two weeks after surgery.	The rate of pathologic 1a and 1b after neoadjuvant chemotherapy.

Secondary Outcome Measures

Name	Time	Method
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.	The 2-year overall survival rate of the whole group.
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.	The 2-year overall survival of the whole group.
R0 resection rate	Two weeks after surgery.	The R0 resection rate of esophagectomy.
pathological complete response rate	Two weeks after surgery.	The rate of pathologic 1a after neoadjuvant chemotherapy.
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.	The 2-year disease free survival of the whole group.
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.	The 2-year disease free survival rate of the whole group.
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.	The 2-year event free survival of the whole group.
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.	The 2-year event free survival rate of the whole group.
adverse events rate	From the date of randomization to 90 days after the last chemotherapy.	The incidence rate of treatment-related adverse events of the whole group assessed by CTCAE v5.0.

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China