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

NCT06009705 | Recruiting DMC

• 1 other identifier: Best-EEC
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Carcinoma

Keywords

esophageal carcinoma; esophageal cancer; immunotherapy; chemoradiotherapy; toripalimab

Outcome Measures

Primary Outcomes (4)

• Assessment of objective remission rate (ORR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.

  Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Objective remission rate (ORR): defined as the proportion of subjects whose tumor volume shrinks to a pre-specified value and can be maintained for the minimum time frame required, incorporating cases in complete remission (CR) and partial remission (PR).

  2022/10/1-2026/4/30

• Assessment of disease control rate (DCR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.

  Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Disease control rate (DCR): the proportion of patients whose tumors shrank or were stable and remained so for a certain period of time, including complete remission (CR), partial remission (PR) and stable disease (SD).

  2022/10/1-2026/4/30

• Assessment of duration of remission (DOR) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.

  Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Duration of remission (DOR): refers to the time between the start of the first assessment of the tumor as complete remission (CR) or partial remission (PR) and the first assessment of PD or death from any cause.

  2022/10/1-2026/4/30

• Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events.

  Adverse events are observed during the course of the study and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).

  2022/10/1-2026/4/30

Secondary Outcomes (2)

• Assessment of overall survival (OS) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.

  2022/10/1-2026/4/30

• Assessment of progression-free survival (PFS) in elderly esophageal cancer patients treated with toripalimab in combination with S-1 and radiotherapy.

  2022/10/1-2026/4/30

Interventions

toripalimab DRUG

JS001, the active ingredient of toripalimab injection, independently developed by Shanghai Junshi Biomedical Technology Co., Ltd, is an independently developed novel recombinant humanised (degree of 97%) anti-PD-1 monoclonal antibody (Chinese Patent License No. CN104250302B, PCT Patent Publication No. WO2014/206107A1), belonging to the human IgG4/Kappa subtype, and introducing a point mutation at the Serine to Proline (S228P) protein site 228 in the hinge region of the IgG4 heavy chain.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older esophageal cancer patients who receive toripalimab combined with radiotherapy and S-1 followed by adjuvant toripalimab maintenance therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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);
• History of malignancy other than oesophageal cancer within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix;
• In the judgement of the investigator, the subject has other factors that may cause him/her to be forced to terminate the study in the middle of the study, e.g., suffering from other serious illnesses (including psychiatric illnesses) that require comorbid treatment, family or social factors that may affect the safety of the subject or the collection of trial data.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Wenbin Shen, PhD

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbin Shen, PhD

CONTACT

+86 15831183879; wbshen1979@sina.com

Hesong Wang, PhD

CONTACT

+86 18810775196; wanghesongmz@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 24, 2023
• Study Start: October 1, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2026
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

CN (1)