Immunotherapy Combined With Chemoradiotherapy for First-line Treatment of Esophageal Squamous Cell Carcinoma（ChinECR）

May 28, 2025 updated by: Hebei Medical University Fourth Hospital

Immunotherapy Combined With Chemoradiotherapy for First-line Treatment of Esophageal Squamous Cell Carcinoma:a Real-world Study From China

This trial aims to assess efficacy and safety of immunotherapy combined with chemoradiotherapy for first-line treatment of esophageal squamous cell carcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Esophageal squamous cell carcinoma is a highly aggressive malignancy, with squamous cell carcinoma accounting for over 90% of esophageal cancer cases in China. According to the American Cancer Society, the 5-year survival rates vary among patients at different stages of esophageal cancer: approximately 50% for early and mid-stage cases, around 26% for locally advanced cases, and only 5% for those with distant metastasis.In recent years, immunotherapy combined with chemotherapy has emerged as the first-line standard treatment for advanced esophageal cancer, and several phase III trials of immunotherapy combined with radiotherapy are currently underway for locally advanced esophageal cancer. Despite being a novel treatment strategy for patients with locally advanced esophageal cancer, there remains a lack of sufficient evidence-based medical data supporting the use of immunotherapy combined with chemoradiotherapy.In recent years, immunotherapy combined with chemotherapy has emerged as the first-line standard treatment for advanced esophageal cancer, and several phase III trials of immunotherapy combined with radiotherapy are currently underway for locally advanced esophageal cancer. Despite being a novel treatment strategy for patients with locally advanced esophageal cancer, there remains a lack of sufficient evidence-based medical data supporting the use of immunotherapy combined with chemoradiotherapy.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Fourth Hospital of Hebei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary participation and written signed informed consent;
  • Age 18-85 years old, gender is not limited;
  • Histologically or cytologically confirmed esophageal squamous cell carcinoma Exclusion Criteria,and patients with suspected brain or bone metastasis at the time of screening should undergo brain MRI or ECT before study enrollment;
  • Physical status score ECOG 0-1;
  • Weight > 40 kg;
  • Expected survival ≥ 6 months;
  • According to RECIST 1.1 guidelines, at least one lesion (not previously receiving radiotherapy) with a maximum diameter ≥ 10 mm as accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except lymph nodes, whose short axis must be ≥ 15 mm); And the lesion is suitable for repeated accurate measurement.;
  • No previous immunotherapy;

  • 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).

  • The female patient has evidence of postmenopausal status, or the urine or serum pregnancy test results of the premenopausal woman are negative. Women who stop menstruating for 12 months without other medical reasons are considered menopausal.

Exclusion Criteria:

  • 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;

  • 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);
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The patients with ESCC receive Immunotherapy combined with chemoradiotherapy

Immunotherapy: intravenously, every 3 weeks for at least 6 months, or until progression, intolerance, or spontaneous withdrawal of the patient.

Chemotherapy drug：albumin-bound paclitaxel 110-130mg/m2,d1,d8;cis-platinum 60-75mg/m2,d1 Q3W Radiotherapy: Total dose of 60Gy/30 times, each time 2.0Gy, 5 times a week from week 7 to week 12 of radiotherapy.
Radiation: radiotherapy
Radiotherapy: Total dose of 60Gy/30 times, each time 2.0Gy, 5 times a week from week 7 to week 12 of radiotherapy.
Drug: Immunotherapy
Immunotherapy: intravenously, every 3 weeks for at least 6 months, or until progression, intolerance, or spontaneous withdrawal of the patient.
Other Names:
  • PD-1/PD-L1
Drug: Chemotherapy drug
TP:albumin-bound paclitaxel 110-130mg/m2,d1,d8;cis-platinum 60-75mg/m2,d1 Q3W
Other Names:
  • TP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of objective remission rate (ORR) in esophageal squamous cell carcinoma treated with immunotherapy combined with chemoradiotherapy
Time Frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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).
Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events
Time Frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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).
Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of overall survival (OS) in esophageal squamous cell carcinoma
Time Frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). OS is defined as the time from the start of enrollment to death from any cause.
Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Assessment of progression-free survival (PFS) in esophageal squamous cell carcinoma
Time Frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). PFS is defined as the time from the start of enrollment until tumor progression or death from any cause.
Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Assessment of disease control rate (DCR) in esophageal squamous cell carcinoma
Time Frame: Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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).
Treatment with immunotherapy for at least 6 months, or from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Fourth Hospital

Investigators

  • Principal Investigator: Wenbin Shen, PhD, Hebei Medical University Fourth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 22, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024KY167

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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