Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer

NCT ID: NCT04688801

Last Updated: 2022-11-16

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

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2027-12-31

Brief Summary

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Surgery with or without neoadjuvant therapy is usually used as the treatment for resectable esophageal cancer or esophageal- gastric junction cancer. Patients who have a poor response to neoadjuvant therapy and have an incomplete (R1) resection or have metastatic lymph nodes in the resection specimen (N+) are especially at risk of recurrence, to continue with the chemotherapy± radiotherapy is often used in these cases. However, the overall survival is still poor. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival. The primary endpoint ofthe study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.

Detailed Description

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Conditions

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Esophageal Cancer Gastroesophageal Cancer Immunotherapy Adjuvant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Chemotherapy± Radiotherapy Group

Chemotherapy± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.

Group Type ACTIVE_COMPARATOR

Chemotherapy Drugs, Cancer

Intervention Type DRUG

Chemotherapy± Radiotherapy after surgery

Chemotherapy + Immunotherapy ± Radiotherapy Group

Chemotherapy + Immunotherapy ± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.

Group Type EXPERIMENTAL

Immunotherapy

Intervention Type DRUG

Chemotherapy + Immuonotherapy ± Radiotherapy after surgery

Interventions

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Chemotherapy Drugs, Cancer

Chemotherapy± Radiotherapy after surgery

Intervention Type DRUG

Immunotherapy

Chemotherapy + Immuonotherapy ± Radiotherapy after surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Histologically proven esophageal or EG-junction carcinoma (Siewert I-II). The heart and lung function can tolerate surgery. The cancer is resectable and incurable therapy will be perfomed.

Exclusion Criteria

EG-junction carcinoma (Siewert III). M1 stage according to the current (8th) version of TNMclassification system. The heart and lung function can't tolerate surgery. R2 Resection Status.
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunpeng Zhao, Doc.

Role: CONTACT

+8617660081916 ext. 17660081916

Facility Contacts

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Yunpeng Zhao, doctor

Role: primary

+8618766188692

Other Identifiers

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Ajuvant immunotherapy ZYP

Identifier Type: -

Identifier Source: org_study_id

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