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

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ClinicalTrials.gov Identifier: NCT04688801
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Shandong University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastroesophageal Cancer Immunotherapy Adjuvant Drug: Chemotherapy Drugs, Cancer Drug: Immunotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer With or Without Preoperative Chemotherapy With High Risk for Recurrence (N+ and/ or R1)
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Chemotherapy± Radiotherapy Group
Chemotherapy± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.
 Drug: Chemotherapy Drugs, Cancer
Chemotherapy± Radiotherapy after surgery
Experimental: Chemotherapy + Immunotherapy ± Radiotherapy Group
Chemotherapy + Immunotherapy ± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.
 Drug: Immunotherapy
Chemotherapy + Immuonotherapy ± Radiotherapy after surgery


Outcome Measures
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Primary Outcome Measures :
  1. disease free survival rate [ Time Frame: 5 years after surgery ]
    disease free survival after surgery

  2. overall survival rate [ Time Frame: 5 years after surgery ]
    overall survival after surgery


Secondary Outcome Measures :
  1. Rate of adverse events [ Time Frame: within 6 months ]
    Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)

  2. Quality of Life （KPS or PS or QOL or EORTC QLQ C30） [ Time Frame: 5 years after therapy ]
    Quality of Life （KPS or PS or QOL or EORTC QLQ C30）after therapy


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688801


Contacts
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Contact: Yunpeng Zhao, Doc. +8617660081916 ext 17660081916 zhaoyunpengsddx@sdu.edu.cn

Locations
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China, Shandong
The Second Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250033
Contact: Yunpeng Zhao, doctor    +8618766188692      
Sponsors and Collaborators
The Second Hospital of Shandong University
More Information
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Responsible Party: The Second Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT04688801    
Other Study ID Numbers: Ajuvant immunotherapy ZYP
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antineoplastic Agents