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

April 15, 2023 updated by: Haihua Yang, Taizhou Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Taizhou, Zhejiang, China, 317000
        • Recruiting
        • Haihua Yang
        • Principal Investigator:
          • Haihua Yang, MD
        • Contact:
        • Sub-Investigator:
          • Jian Zhu, MD
      • Taizhou, Zhejiang, China, 318025
        • Recruiting
        • Taizhou Enze Medical Center(Group) Enze Hospital
        • Principal Investigator:
          • Haihua Yang, MD
        • Contact:
        • Sub-Investigator:
          • Chao Zhou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Ⅱa to Ⅲ.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toripalimab & Radiotherapy
Toripalimab, 240mg/d, radiotherapy D7, D28; Thoracic radiotherapy, 54Gy/25F, IMRT; Maintenance Toripalimab therapy after completed radiotherapy, 240mg/Q3W, until progression or 1 years or intolerant
Drug: Toripalimab
Toripalimab 240mg day7 and day 28，every 3 weeks 1month after radiotherapy，until progression or 1 years or intolerant.
Other Names:
  • JS001
  • TAB001
Radiation: IMRT
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Other Names:
  • Irradiation
  • intensity modulation radiation therapy
Active Comparator: Chemotherapy & Radiotherapy
Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT.
Radiation: IMRT
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Other Names:
  • Irradiation
  • intensity modulation radiation therapy
Drug: Tegafur
Tegafur 70mg/m2/day day 1 to day 14，and day 29 to day42.
Other Names:
  • S-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free survival
Time Frame: Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taizhou Hospital

Investigators

  • Principal Investigator: Taizhou Enze Medical Center(Group) Enze Hospital Yang, MD, Taizhou Enze Medical Center (Group) Enze Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 15, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 15, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREEN Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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