search
Back to results

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

Primary Purpose

Esophageal Cancer, Radiation Therapy, Immunotherapy

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Tegafur
IMRT
Sponsored by
Taizhou Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

70 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Haihua YangRecruiting
  • Taizhou Enze Medical Center(Group) Enze HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Toripalimab & Radiotherapy

Chemotherapy & Radiotherapy

Arm Description

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

Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 3, 2023
Last Updated
April 15, 2023
Sponsor
Taizhou Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05817201
Brief Title
Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy
Official Title
A Phase II and III, Randomized, Multicenter Clinical Study: Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taizhou Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Radiation Therapy, Immunotherapy, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toripalimab & Radiotherapy
Arm Type
Experimental
Arm Description
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
Arm Title
Chemotherapy & Radiotherapy
Arm Type
Active Comparator
Arm Description
Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Other Intervention Name(s)
JS001, TAB001
Intervention Description
Toripalimab 240mg day7 and day 28,every 3 weeks 1month after radiotherapy,until progression or 1 years or intolerant.
Intervention Type
Drug
Intervention Name(s)
Tegafur
Other Intervention Name(s)
S-1
Intervention Description
Tegafur 70mg/m2/day day 1 to day 14,and day 29 to day42.
Intervention Type
Radiation
Intervention Name(s)
IMRT
Other Intervention Name(s)
Irradiation, intensity modulation radiation therapy
Intervention Description
PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W
Primary Outcome Measure Information:
Title
Overall survival
Description
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
Time Frame: 2 years
Secondary Outcome Measure Information:
Title
Progression-Free survival
Description
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
Time Frame: 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haihua Yang, MD
Phone
13819639006
Email
yhh93181@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taizhou Enze Medical Center(Group) Enze Hospital Yang, MD
Organizational Affiliation
Taizhou Enze Medical Center (Group) Enze Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haihua Yang
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haihua Yang
Phone
13819639006
Email
yhh93181@hotmail.com
First Name & Middle Initial & Last Name & Degree
Haihua Yang, MD
First Name & Middle Initial & Last Name & Degree
Jian Zhu, MD
Facility Name
Taizhou Enze Medical Center(Group) Enze Hospital
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
318025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haihua Yang
Phone
13819639006
Email
yhh93181@hotmail.com
First Name & Middle Initial & Last Name & Degree
Haihua Yang, MD
First Name & Middle Initial & Last Name & Degree
Chao Zhou, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs