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Esophageal Squamous Cell CarcinomaNCT04851132

Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma

A study testing Radiotherapy and Durvalumab in people with Esophageal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Radiotherapy and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
11 Mar 2021to Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age 70-85 years old, both men and women
  • Histologically confirmed esophageal squamous cell carcinoma located in thoracic segment, treatment naive
  • Stage cT2-4aNanyM0 (AJCC 8 TNM classification)
  • Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy
  • ECOG PS 0-2
  • Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
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  • No severe abnormalities of the Hematologic system, heart, lung, liver, kidney, and immunodeficiency
  • 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
  • INR or PT or aPTT ≤ 1.5 x ULN
  • Life expectancy more than 6 months
  • 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

Who cannot join

  • Complete esophageal obstruction that unable to eat fluid and cannot provide necessary nutrition through nasal feeding
  • Patients with obvious ulcer or esophageal perforation or hematemesis
  • Placement of esophagotracheal stents
  • Has a history or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumonoconiosis, drug-associated pneumonia, severe impairment of pulmonary function
  • Has had major surgery within 28 days prior to the start of the treatment
  • 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);
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  • 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)
  • 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
  • Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
  • 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
  • System infections that require treatment
  • Received a live vaccine within 4 weeks of the first dose of study medication
  • 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
  • Patients who have participated in other clinical trials within 30 days
  • Drug addiction, chronic alcoholism and AIDS
  • Patients with uncontrollable seizures or loss of self-control due to mental illness
  • Those with a history of severe allergy or specific physique
  • The investigators judge not suitable for inclusion

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, 100021

    Zhouguang Hui, M.D., 8610-87787230, drhuizg@163.com

    Zhouguang Hui, M.D.

    Recruiting

Other trials in China

About this study

Official title: Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial

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.

Being tested
Radiotherapy, Durvalumab
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

    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.

  • DurvalumabDrug

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

Study groups in NCT04851132
Study groupRoleWhat they receive
Exprimental ArmExperimentalIMRT plus Durvalumab
Receives: Radiation: Radiotherapy; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1-year

Secondary outcomes (6)

  1. Overall survival (OS)

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

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: during the intervention up to 60 weeks

  5. Number of participants with an adverse event

    Evaluanted by CTCAE 5.0

    Measured: 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.

    Measured: up to 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2021
  2. Study start11 Mar 2021
  3. Primary completionMar 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
RT + Durvalumab
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04851132
Sponsor's protocol ID
NCC2840
Status last verified
Jun 2021
First submitted
5 Apr 2021
Last updated
22 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiotherapy and Durvalumab in people with Esophageal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 1-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04851132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.

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