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NCT Number: NCT04688801

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

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.

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Key information

Conditions

Esophageal Cancer Adjuvant Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms GastroEsophageal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Immunotherapy Neoplasms Neoplasms by Site

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

Location status: Recruiting

Location contact

Yunpeng Zhao, doctor

CONTACT

+8618766188692

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chemotherapy Drugs, Cancer

Drug

Chemotherapy± Radiotherapy after surgery

Immunotherapy

Drug

Chemotherapy + Immuonotherapy ± Radiotherapy after surgery

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Yunpeng Zhao, Doc.

CONTACT

[email protected]

+8617660081916 ext. 17660081916

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Dec 30, 2020
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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