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

NCT06478355 | Active Not Recruiting DMC

• 1 other identifier: 2024KY167
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ESCC

Keywords

ESCC; immunotherapy; chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• Assessment of objective remission rate (ORR) in esophageal squamous cell carcinoma treated with immunotherapy combined with chemoradiotherapy

  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

  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 Outcomes (3)

• Assessment of overall survival (OS) in esophageal squamous cell carcinoma

  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

  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

  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

Study Arms (1)

The patients with ESCC receive Immunotherapy combined with chemoradiotherapy

EXPERIMENTAL

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.

Drug: Immunotherapy; Drug: Chemotherapy drug; Radiation: radiotherapy

Interventions

Immunotherapy DRUG

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

Also known as: PD-1/PD-L1

The patients with ESCC receive Immunotherapy combined with chemoradiotherapy

Chemotherapy drug DRUG

TP:albumin-bound paclitaxel 110-130mg/m2,d1,d8;cis-platinum 60-75mg/m2,d1 Q3W

Also known as: TP

The patients with ESCC receive Immunotherapy combined with chemoradiotherapy

radiotherapy RADIATION

Radiotherapy: Total dose of 60Gy/30 times, each time 2.0Gy, 5 times a week from week 7 to week 12 of radiotherapy.

The patients with ESCC receive Immunotherapy combined with chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and written signed informed consent;
• Age 18-85 years old, gender is not limited;

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

Related Publications (1)

• Liu X, Wen J, Zhang Y, Wang C, Liu Y, Qian P, Cao J, Hou Q, Xu Y, Lin Z, Ye X, Hou M, Gui Y, Wang L, Zhou W, Zeng Z, Song Y, Luo H, Lv J, Shen W. Impact of first-line chemoimmunotherapy with or without radiotherapy on the prognosis of patients with locally advanced or metastatic esophageal squamous cell carcinoma: a multicenter, real-world, retrospective cohort study from China (NCT06478355). Front Immunol. 2025 Jul 28;16:1633930. doi: 10.3389/fimmu.2025.1633930. eCollection 2025.

  PMID: 40791599 DERIVED

MeSH Terms

Interventions

Immunotherapy; Immune Checkpoint Inhibitors; Radiotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Wenbin Shen, PhD

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 27, 2024
• Study Start: January 1, 2018
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 3, 2025

Record last verified: 2024-06

Locations

CN (1)