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Status unknownNCT04851132Updated Jun 22, 2021

Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma

An interventional study of Radiotherapy and Durvalumab in Esophageal Squamous Cell Carcinoma, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2021-06-22.

Sponsored by Chinese Academy of Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Study summary

The incidence and mortality of esophageal cancer are at the forefront in China, among which the elderly patients account for a large proportion. Concurrent chemoradiotherapy is the standard treatment for inoperable locally advanced esophageal cancer. Most elderly patients with esophageal cancer cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal cancer.

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Conditions studied

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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 33 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 70-85 years old, both men and women
  2. Histologically confirmed esophageal squamous cell carcinoma located in thoracic segment, treatment naive
  3. Stage cT2-4aNanyM0 (AJCC 8 TNM classification)
  4. Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy
  5. ECOG PS 0-2
  6. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  7. No severe abnormalities of the Hematologic system, heart, lung, liver, kidney, and immunodeficiency
  8. Adequate bone marrow and organ function as defined below (excluding the use of any blood components and cell growth factors within 7 days):

    • Absolute neutrophil count≥1,500/mm3
    • Platelets ≥ 100,000/mm3
    • Hemoglobin ≥ 5.6 mmol/L (9g/dL)
    • Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥50 mL/min by Cockcroft-Gault estimation
    • Total bilirubin ≤ 1.5 x ULN
    • ALT and AST ≤ 2.5 x ULN
    • Proteinuria \< 2+, for subjects with urine protein ≥ 2 + at baseline, urine samples should be collected within 24 hours and urine protein in 24 hours should be ≤ 1g
  9. INR or PT or aPTT ≤ 1.5 x ULN
  10. Life expectancy more than 6 months
  11. Ability to understand and willingness to sign an IRB approved written informed consent document, and capable of proper therapeutic compliance, and accessible to correct follow-up

Exclusion criteria

Exclusion Criteria:

  1. Complete esophageal obstruction that unable to eat fluid and cannot provide necessary nutrition through nasal feeding
  2. Patients with obvious ulcer or esophageal perforation or hematemesis
  3. Placement of esophagotracheal stents
  4. Has a history or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumonoconiosis, drug-associated pneumonia, severe impairment of pulmonary function
  5. Has had major surgery within 28 days prior to the start of the treatment
  6. Immunosuppressive drugs used within 4 weeks prior to the initial study treatment, excluding local glucocorticoids, or systemic glucocorticoids at physiological doses (i.e., no more than 10 mg/ day of prednisone or equivalent doses of other glucocorticoids);
  7. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, glomerulonephritis, thyroiditis (patients with vitiligo or asthma has been completely relieved in childhood, and do not need any intervention during adulthood can be included; patients with type I diabetes with good insulin control can also be included; hypothyroidism caused by autoimmune thyroiditis requiring hormone replacement therapy can also be included)
  8. Has had congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (HCV-RNA ≥ 103 copies/ml; For chronic hepatitis B virus carriers, HBV viral load must be \< 2000 IU/ml (\< 104 copies / ml), and must receive antiviral therapy at the same time before they can be enrolled
  9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
  10. Uncontrolled clinically significant disease, including active infection, uncontrolled hypertension, unstable angina pectoris, angina within the past 3 months, heart failure > NYHA II, myocardial infarction within the past 6 months, severe arrhythmias requirement for treatment or intervention, liver/kidney or metabolic disease
  11. System infections that require treatment
  12. Received a live vaccine within 4 weeks of the first dose of study medication
  13. Synchronous or metachronous second primary malignancy. Participants with basal cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded from the study
  14. Patients who have participated in other clinical trials within 30 days
  15. Drug addiction, chronic alcoholism and AIDS
  16. Patients with uncontrollable seizures or loss of self-control due to mental illness
  17. Those with a history of severe allergy or specific physique
  18. The investigators judge not suitable for inclusion
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (estimated)

Study arms

  • Experimental
    Exprimental Arm

    IMRT plus Durvalumab

    Radiation: Radiotherapy · Drug: Durvalumab

Interventions

  • RadiationRadiotherapy

    IMRT (Intensity Modulated RT) or 3D-CRT (three-dimensional conformal radiotherapy); 95% PGTV 59.92Gy/2.14Gy/28f; 95% GTVnd 59.92Gy/2.14Gy/28f; 95% PTV 50.40Gy/1.80Gy/28f; 5 days a week; 6 weeks.

  • DrugDurvalumab

    Durvalumab 1000 mg, intravenously (IV), on Day 1 of radiotherapy, every 3 weeks for up to 18 administrations.

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What researchers measure

Primary outcomes

  1. Progression-free survival (PFS)

    PFS was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. Progression-free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.

    Time frame: 1-year

Secondary outcomes

  1. Overall survival (OS)

    Overall survival defined as the time from enrollment to death due to any cause.

    Time frame: 1-, 2- and 3-year

  2. Progression-free survival (PFS)

    PFS was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1. Progression-free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.

    Time frame: 2- and 3-year

  3. Objective Response Rate (ORR)

    ORR was Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Time frame: during the intervention up to 60 weeks

  4. Disease Control Rate (DCR)

    DCR was Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Time frame: during the intervention up to 60 weeks

  5. Number of participants with an adverse event

    Evaluanted by CTCAE 5.0

    Time frame: Up to 60 weeks

  6. Quality of Life (QOL): questionnaire EORTC QLQ-C30 (version 3)

    Evaluate the quality of life via questionnaire EORTC QLQ-C30 (version 3), minimum value 30, maximum value 126, higher scores mean a worse outcome.

    Time frame: up to 60 weeks

Other outcomes

  1. Quality of Life (QOL): questionnaire EORTC QLQ-OES18

    Evaluate the quality of life via questionnaire EORTC QLQ-OES18, minimum value 18, maximum value 72, higher scores mean a better outcome.

    Time frame: up to 60 weeks

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Study locations

1 of 1 sites recruiting
  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, 100021, China
    • Zhouguang Hui, M.D. · Contact · drhuizg@163.com · 8610-87787230
    • Zhouguang Hui, M.D. · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04851132
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Zhouguang Hui, M.D. (Chief physician, Director of VIP Department, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Apr 20, 2021
Start date
Mar 11, 2021
Primary completion
Mar 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Jun 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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