Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma

NCT05937438 | Recruiting Phase 1

• 1 other identifier: 2023-ky 148
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal squamous cell carcinoma is a common malignancy in China. Although neoadjuvant chemoradiotherapy followed by esophagectomy remains a standard modality for locally advanced esophageal squamous cell carcinoma, esophagectomy followed by postoperative radiotherapy is also prevalent in China. Several retrospective studies demonstrated that postoperative radiotherapy could improve the prognosis of patients. Nevertheless, there still existed approximately 11.5% and 17.2% of total patients developing local-regional relapse and hematological metastasis. The result of Checkmate 577 has shown that postoperative immunotherapy of nivolumab could improve the disease-free survival (median Disease-free Survival 29.7 mos vs. 11.0 mos). Therefore, investigators aimed to implement a pilot study to explore the safety and efficacy of combining postoperative radiotherapy and immunotherapy for patients with locally advanced esophageal squamous cell carcinoma after esophagectomy.

Conditions

Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 1-year disease-free survival

  1-year disease-free survival

  1 year

Secondary Outcomes (3)

• Rate of irradiation-induced or immune-induced pneumonitis

  1 year

• 3-year disease-free survival

  3 year

• 3-year overall survival

  3 year

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Esophagectomy+postoperative radiotherapy+immunotherapy

Drug: Immune Checkpoint Inhibitors

Controlled Arm

OTHER

Esophagectomy+postoperative radiotherapy

Drug: Immune Checkpoint Inhibitors

Interventions

Immune Checkpoint Inhibitors DRUG

Patients assigned to experimental arm would receive the maintenance treatment of immune checkpoint inhibitor (Tislelizumab or Camrelizumab) after postoperative radiotherapy for one year

Controlled Arm; Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old.
• After esophagectomy.
• Confirmation of squamous cell carcinoma by pathological examination.
• Pathological staging of pIIb-IVa.
• Over 12 lymph nodes dissected during surgery.
• ECOG 0-1.
• Signature of inform consent by patients

You may not qualify if:

• Younger than 18 years old or older than 75 years old.
• Without esophagectomy.
• Non-squamous cell carcinoma.
• Pathological staging of pI, IIa, IVb.
• Less than 12 lymph nodes dissected during surgery.
• ECOG 2-3 g. no signature of inform consent.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provicial Hospital

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Immune Checkpoint Inhibitors

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)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Dong Qian, M.D.

  The First Affiliated Hospital of USTC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Qian, M.D.

CONTACT

+86-19156007756; qiandong@ustc.edu.cn

Dong Qian, M.D.

CONTACT

+8619156007756; qiandong@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients enrolled would be randomly assigned to experimental arm (esophagectomy followed by postoperative radiotherapy with immunotherapy) and controlled arm (esophagectomy followed by postoperative radiotherapy).

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 10, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)