Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma

NCT04851132 | Unknown

• 1 other identifier: NCC2840
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

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.

  1-year

Secondary Outcomes (6)

• Overall survival (OS)

  1-, 2- and 3-year

• Progression-free survival (PFS)

  2- and 3-year

• Objective Response Rate (ORR)

  during the intervention up to 60 weeks

• Disease Control Rate (DCR)

  during the intervention up to 60 weeks

• Number of participants with an adverse event

  Up to 60 weeks

Other Outcomes (1)

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

  up to 60 weeks

Study Arms (1)

Exprimental Arm

EXPERIMENTAL

IMRT plus Durvalumab

Radiation: Radiotherapy; Drug: Durvalumab

Interventions

Radiotherapy RADIATION

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.

Exprimental Arm

Durvalumab DRUG

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

Exprimental Arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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);
• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Director of VIP Department

Model Details: RT + Durvalumab

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 20, 2021
• Study Start: March 11, 2021
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)