Clinical trial NCT05817201: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Esophageal Cancer
Radiation Therapy
Immunotherapy
Chemotherapy
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall survival
timeFrame: Time Frame: 2 years
Secondary outcomes:
measure: Progression-Free survival
timeFrame: Time Frame: 2 years
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Haihua Yang
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Enze Medical Center(Group) Enze Hospital
state: Zhejiang
Study officials:
affiliation: Taizhou Enze Medical Center Group
name: Taizhou Enze Medical Center(Group) Enze Hospital Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: