Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy

Esophageal Cancer Clinical Trial

Official title:

A Phase II and III, Randomized, Multicenter Clinical Study: Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817201
• Other study ID #: TREEN Trial
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Taizhou Hospital
• Contact: Haihua Yang, MD
• Phone: 13819639006
• Email: yhh93181[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer.

Description:

Older patients with esophageal cancer are universally intolerant to chemotherapy.

This study is performed to explore a non-chemotherapy strategy for elderly esophageal cancer patients.

Participants will be treated with Toripalimab monoclonal antibody maintenance versus S-1 combined with radiotherapy, intended to explore the efficacy and safety of non-chemotherapy strategy for elderly esophageal cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

Inclusion Criteria:

Carcinoma of the esophagus confirmed histologically or cytologically. Lesions that can be measured according to the RECIST standard. AJCC/UICC Staging of Esophageal Carcinoma (Sixth Edition) Clinical Staging ?a to ?.

Age = 70 years = 85 years old. The ECOG physical state score is 0 to 1. No esophageal perforation, active esophageal bleeding, or significant invasion of trachea or thoracic aorta.

Patients with not previously received chest radiation and speech therapy, immunotherapy, or biological therapy.

Hemoglobin = 100g/L, platelets = 100 * 10^9/L, absolute neutrophil count = 1.5 * 10^9/L? Serum creatinine = 1.25 times UNL or creatinine clearance = 60 mL/min. Serum bilirubin = 1.5 times UNL, AST (SGOT) and ALT (SGPT) = 2.5 times UNL, and alkaline phosphatase = 5 times UNL.

No history of interstitial pneumonia or previous interstitial pneumonia. FEV1>0.8L?

The patient signs a formal informed consent form.

Exclusion Criteria:

Patients with chest radiation, chemotherapy, or surgical resection of esophageal cancer before the start of this trial Patients with multifocal esophageal cancer, and the lower boundary of the primary lesion of the esophagus is less than 3cm from the esophageal gastric junction.

Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a previous history of interstitial pneumonia.

Patients with obvious esophageal ulcer, moderate or above pain in chest and back, and symptoms of esophageal perforation.

Patients who cannot understand or may not comply with the test requirements. Patients with other malignant lesions, except for curable skin cancer (non melanoma), cervical carcinoma in situ or malignant disease that has been cured for = 5 years.

Researchers believe that some obvious diseases should be excluded from this study.

Related Conditions & MeSH terms

• Chemotherapy
• Esophageal Cancer
• Esophageal Neoplasms
• Immunotherapy
• Radiation Therapy

Intervention

Drug:
• Toripalimab
Toripalimab 240mg day7 and day 28,every 3 weeks 1month after radiotherapy,until progression or 1 years or intolerant.
• Tegafur
Tegafur 70mg/m2/day day 1 to day 14,and day 29 to day42.

Radiation:
• IMRT
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W

Locations

Country	Name	City	State
China	Haihua Yang	Taizhou	Zhejiang
China	Taizhou Enze Medical Center(Group) Enze Hospital	Taizhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The OS was defined as the duration from the date of of initiation of treatment to the date of death from any cause or censored at the date of the last follow-up.	Time Frame: 2 years
Secondary	Progression-Free survival	Progression-free survival (PFS) will be calculated from the date of initiation of treatment until the day of documented failure (local recurrence or metastasis occurrence) or until the date of the last follow-up visit.	Time Frame: 2 years