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Toripalimab Combined With Radiotherapy and S-1 for Older Patients With Esophageal Cancer

Efficacy and Safety of Toripalimab Combined With Radiotherapy and S-1 Followed by Adjuvant Toripalimab Maintenance Therapy for Older Patients With Esophageal Cancer

NCT06009705•Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

Summary

This trial aims to assess efficacy and safety of toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy for older patients with stage II-III esophageal cancer.

Detailed Description

With the aging of the population, the number of elderly esophageal cancer patients is gradually increasing. For non-metastatic esophageal cancer patients, surgery is the first choice of treatment, but elderly esophageal cancer patients are often unable to tolerate surgical treatment due to more comorbidities and poor physical condition, etc. The results of previous studies have shown that the effect of radiotherapy treatment is also unsatisfactory, and the 5-year survival rate of esophageal cancer patients treated with radiotherapy is only 15-25%, which makes the clinical treatment of elderly patients even more difficult due to their poor physical tolerance. A multicentre randomised phase III clinical trial (NCT02813967) demonstrated that concurrent radiotherapy and S-1 treatment in elderly patients with esophageal cancer was tolerable and provided significant benefit compared with radiotherapy alone. In recent years, tumor immunotherapy has shown some efficacy in the field of cancer treatment by activating the body's own immune system to fight tumors. Therefore, this trial aims to assess efficacy and safety of toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy for older patients with stage II-III esophageal cancer. The primary study endpoints are objective remission rate (ORR), disease control rate (DCR), duration of remission (DOR) and safety. Secondary study endpoints are overall survival (OS) and progression-free survival (PFS).

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntary participation and written signed informed consent;
•Age ≥65 years old, gender is not limited;
•Histologically or cytologically confirmed esophageal cancer;
•Elderly patients with stage I-III esophageal cancer who are inoperable or refuse to undergo surgery and can tolerate immunotherapy combined with S-1 and radiotherapy;
•Physical status score ECOG 0-2;
•Expected survival ≥ 6 months;
•no serious abnormalities of haematopoietic, cardiac, pulmonary, hepatic and renal functions and immunodeficiency (Haematology: white blood cells ≥3.5×109/L; neutrophils ≥1.5×109/L; haemoglobin ≥90g/L; platelets ≥100×109/L. Liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) ≤2.5 times the upper limit of normal; creatinine ≤1.5 times the upper limit of normal; albumin ≥30 g/L. Coagulation: International Normalised Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, PT or INR is acceptable as long as the PT or INR is within the range of the anticoagulant drug formulation. Echocardiographic assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%). Pulmonary function FEV1 ≥70% of % of predicted value and DLCO ≥60% of % of predicted value).
•Have at least one measurable lesion as judged by RECIST 1.1 criteria.

Exclusion Criteria

•Distant organ metastases (excluding supraclavicular lymph nodes) as determined by CT evaluation during screening and prior imaging;
•Pre-treatment with oesophageal fistula, perforation, or malignant disease;
•have received prior radiotherapy to the chest;
•having any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included if hormone replacement therapy is effective), etc.), and a history of immunosuppressive drug use within 28 days, with the exception of the use of hormones for the purpose of dealing with toxicity from radiotherapy;
•Previously received or are receiving other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1, or are currently participating in other interventional clinical studies for treatment;
•Have received other anti-tumour therapy (including herbal therapy with anti-tumour effect) within 4 weeks prior to the first dose of the study; have received long-term systemic immunotherapy or hormone therapy (except physiological replacement therapy, e.g., oral thyroxine for hypothyroidism) within 4 weeks prior to the first dose of the study; and have been treated with other experimental drugs or interventional clinical studies within 4 weeks prior to the first dose of the study;
•Known hypersensitivity to large protein preparations, or to any of the components within toripalimab, S-1 capsules and their preparations;
•Patients with uncontrolled clinical cardiac symptoms or disease such as (1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
•with congenital or acquired immune function defects (e.g., HIV-infected patients), active hepatitis B (HBV-DNA ≥104 copies/ml) or hepatitis C (hepatitis C antibody-positive with HCV-RNA above the lower limit of detection of the analytical method), or active tuberculosis;
•Have an active infection or unexplained fever \>38.5°C within 2 weeks prior to screening (at the investigator's discretion, subjects may be enrolled for fever arising from tumours);
+2 more criteria

Locations (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Key Dates

Start Date

October 1, 2022

Primary Completion Date

April 30, 2025

Completion Date

April 30, 2026

Last Updated

August 24, 2023

Enrollment

ESTIMATED participants

Conditions

Esophageal Carcinoma

Interventions

toripalimab

DRUG

Contacts

Wenbin Shen, PhD

CONTACT

+86 15831183879 wbshen1979@sina.com

Hesong Wang, PhD

CONTACT

+86 18810775196 wanghesongmz@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Toripalimab Combined With Radiotherapy and S-1 for Older Patients With Esophageal Cancer

Inclusion Criteria

Exclusion Criteria

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