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Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma

NCT ID: NCT04506138

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2025-12-31

Brief Summary

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This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma

Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Camrelizumab plus Chemotherapy

Group Type EXPERIMENTAL

Camrelizumab

Intervention Type DRUG

Camrelizumab 200mg D1, D22

Paclitaxel for Injection (Albumin Bound)

Intervention Type DRUG

Paclitaxel for Injection (Albumin Bound) 100mg/m\^2 D1, D8, D22, D29

Carboplatin

Intervention Type DRUG

Carboplatin AUC5 D1, D22

Interventions

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Camrelizumab

Camrelizumab 200mg D1, D22

Intervention Type DRUG

Paclitaxel for Injection (Albumin Bound)

Paclitaxel for Injection (Albumin Bound) 100mg/m\^2 D1, D8, D22, D29

Intervention Type DRUG

Carboplatin

Carboplatin AUC5 D1, D22

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological diagnosis of thoracic Esophageal squamous cell carcinoma
* ECOG performance status 0-1
* Age 18-75 years
* Resectable disease, cT2-4aNanyM0 or cT1-3N+M0
* Life expectancy more than 6 months
* Use of an effective contraceptive for adults to prevent pregnancy

Exclusion Criteria

* Not suitable for surgery
* Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC
* Prior esophageal, gastric, or gastro-esophageal junction surgery
* Esophageal ulcer, esophageal perforation，chest pain（≥middle level）
* Pregnant or lactating women
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chenqixun

Director of Thoracic Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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ZJCH-2020183-II-ESCC

Identifier Type: -

Identifier Source: org_study_id