Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemotherapy Drugs, Cancer, Immunotherapy.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer, Gastroesophageal Cancer, Immunotherapy, Adjuvant. Basic parameters: 25 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug Chemotherapy Drugs, Cancer
Chemotherapy± Radiotherapy after surgery - Drug Immunotherapy
Chemotherapy + Immuonotherapy ± Radiotherapy after surgery
Primary outcome measures
- disease free survival rate [Time frame: 5 years after surgery]
- overall survival rate [Time frame: 5 years after surgery]
Secondary outcome measures (2)
- Rate of adverse events [Time frame: within 6 months]
- Quality of Life （KPS or PS or QOL or EORTC QLQ C30） [Time frame: 5 years after therapy]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Hospital of Shandong University — Jinan
Identifiers
NCT: NCT04688801 · Ajuvant immunotherapy ZYP