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

NCT04688801 | Recruiting DMC

• 1 other identifier: Ajuvant immunotherapy ZYP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Gastroesophageal Cancer; Immunotherapy; Adjuvant

Outcome Measures

Primary Outcomes (2)

• disease free survival rate

  disease free survival after surgery

  5 years after surgery

• overall survival rate

  overall survival after surgery

  5 years after surgery

Secondary Outcomes (2)

• Rate of adverse events

  within 6 months

• Quality of Life （KPS or PS or QOL or EORTC QLQ C30）

  5 years after therapy

Study Arms (2)

Chemotherapy± Radiotherapy Group

ACTIVE COMPARATOR

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

Drug: Chemotherapy Drugs, Cancer

Chemotherapy + Immunotherapy ± Radiotherapy Group

EXPERIMENTAL

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

Drug: Immunotherapy

Interventions

Chemotherapy Drugs, Cancer DRUG

Chemotherapy± Radiotherapy after surgery

Chemotherapy± Radiotherapy Group

Immunotherapy DRUG

Chemotherapy + Immuonotherapy ± Radiotherapy after surgery

Chemotherapy + Immunotherapy ± Radiotherapy Group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Antineoplastic Agents; Immunotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Yunpeng Zhao, Doc.

CONTACT

+8617660081916; zhaoyunpengsddx@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: December 30, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

CN (1)