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

Phase 2

Recruiting

• Conditions: Chemotherapy; Immunotherapy; Esophageal Cancer; Radiation Therapy
• Interventions: Drug: Toripalimab; Drug: Tegafur; Radiation: IMRT

• Registration Number: NCT05817201
• Lead Sponsor: Taizhou Hospital

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.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-15
• Last Update Submitted: 2023-04-15
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy & Radiotherapy	IMRT	Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT.
Toripalimab & Radiotherapy	IMRT	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
Toripalimab & Radiotherapy	Toripalimab	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
Chemotherapy & Radiotherapy	Tegafur	Tegafur, 70mg/m2/d, radiotherapy D1-14, D29-42; Thoracic radiotherapy, 54Gy/25F, IMRT.

Primary Outcome Measures

Name	Time	Method
Overall survival	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.

Secondary Outcome Measures

Name	Time	Method
Progression-Free survival	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.

Trial Locations

Locations (2)

Haihua Yang; 🇨🇳 Taizhou, Zhejiang, China

Taizhou Enze Medical Center(Group) Enze Hospital; 🇨🇳 Taizhou, Zhejiang, China