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

Sponsor

The Second Hospital of Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04688801

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

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

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

Primary Outcome Measures

disease free survival rate [5 years after surgery]
disease free survival after surgery
overall survival rate [5 years after surgery]
overall survival after surgery

Secondary Outcome Measures

Rate of adverse events [within 6 months]
Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)
Quality of Life （KPS or PS or QOL or EORTC QLQ C30） [5 years after therapy]
Quality of Life （KPS or PS or QOL or EORTC QLQ C30）after therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The Second Hospital of Shandong University	Jinan	Shandong	China	250033

Sponsors and Collaborators

The Second Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Second Hospital of Shandong University

ClinicalTrials.gov Identifier:

NCT04688801

Other Study ID Numbers:

Ajuvant immunotherapy ZYP

First Posted:

Dec 30, 2020

Last Update Posted:

Dec 30, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Antineoplastic Agents

Study Results

No Results Posted as of Dec 30, 2020