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

NCT05817201 | Unknown Phase 2

• 1 other identifier: TREEN Trial
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophageal Cancer; Radiation Therapy; Immunotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression-Free survival

  Time Frame: 2 years

Study Arms (2)

Toripalimab & Radiotherapy

EXPERIMENTAL

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; Radiation: IMRT

Chemotherapy & Radiotherapy

ACTIVE COMPARATOR

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

Drug: Tegafur; Radiation: IMRT

Interventions

Toripalimab DRUG

Toripalimab 240mg day7 and day 28，every 3 weeks 1month after radiotherapy，until progression or 1 years or intolerant.

Also known as: JS001, TAB001

Toripalimab & Radiotherapy

Tegafur DRUG

Tegafur 70mg/m2/day day 1 to day 14，and day 29 to day42.

Also known as: S-1

Chemotherapy & Radiotherapy

IMRT RADIATION

PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W

Also known as: Irradiation, intensity modulation radiation therapy

Chemotherapy & Radiotherapy; Toripalimab & Radiotherapy

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taizhou Hospital: lead

Study Sites (2)

Haihua Yang

Taizhou, Zhejiang, 317000, China

RECRUITING

Taizhou Enze Medical Center(Group) Enze Hospital

Taizhou, Zhejiang, 318025, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

toripalimab; Tegafur; S 1 (combination); Radiation

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)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Physical Phenomena

Study Officials

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

  Taizhou Enze Medical Center Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haihua Yang, MD

CONTACT

13819639006; yhh93181@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Radiation Oncology

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (2)