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Prospective clinical study on the efficacy and safety of immune checkpoint inhibitors at different time after concurrent chemo-radiotherapy in unresectable locally advanced esophageal cancer

Prospective clinical study on the efficacy and safety of immune checkpoint inhibitors at different time after concurrent chemo-radiotherapy in unresectable locally advanced esophageal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083825
Enrollment
Unknown
Registered
2024-05-06
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Group 1:Immunotherapy was added within 60 days after concurrent chemo-radiotherapy.
Group 2:Immunotherapy was added without 60 days after concurrent chemo-radiotherapy.

Sponsors

Weihai Municipal Hospital,Cheeloo College of Medicine,Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years old, ECOG score 0 or 1-2; (2) No congestive heart failure, unstable angina pectoris, or unstable arrhythmia occurred in the past 6 months; Life expectancy assessment > 3 months; (3) no previous history of immune disease; (4) Esophageal cancer without perforation signs; (5) Radiotherapy dose of at least 4500cGy; (6) Be able to adhere to the protocol for the study period; (7) The patient should undergo chest CT scan and esophageal barium meal examination; Adequate bone marrow function; Adequate liver function; Full renal function.

Exclusion criteria

Exclusion criteria: (1) Esophageal perforation; (2) Presence of esophageal stent, potential gastrointestinal bleeding or massive gastrointestinal bleeding; (3) Allergic disease, history of severe drug allergy, known to be allergic to immune drugs; (4) The presence of any active autoimmune disease or a history of autoimmune disease; (5) Concurrent severe infection (such as intravenous use of antibiotics, antifungal or antiviral drugs, etc. (6) Congenital or acquired immune deficiency or active hepatitis; (7) Mental illness that interferes with study compliance.

Design outcomes

Primary

MeasureTime frame
Total reaction rate;

Secondary

MeasureTime frame
safety;progression free survival;overall survival;Pneumonia incidence rate;

Countries

China

Contacts

Public ContactWang Shuwei

Weihai Municipal Hospital,Cheeloo College of Medicine,Shandong University

wangshw1120@163.com+86 186 6037 8862

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026