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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-80
SponsorThe Second Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemotherapy Drugs, Cancer

    Drug

    Chemotherapy± Radiotherapy after surgery

  • Immunotherapy

    Drug

    Chemotherapy + Immuonotherapy ± Radiotherapy after surgery

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Chemotherapy± Radiotherapy GroupActive comparator 1 intervention
Group B: Chemotherapy + Immunotherapy ± Radiotherapy GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

disease free survival rate

disease free survival after surgery

Time frame
5 years after surgery
2

overall survival rate

overall survival after surgery

Time frame
5 years after surgery

Secondary outcomes

1

Rate of adverse events

Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)

Time frame
within 6 months
2

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

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

Time frame
5 years after therapy

Other outcomes

Sponsors and contacts

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