Immunotherapy After Radiotherapy in Elderly ESCC (TREE)

March 17, 2023 updated by: The Central Hospital of Lishui City

Toripalimab After Radiotherapy Alone in Elderly Esophageal Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial

The incidence and mortality of esophageal squamous cell carcinoma are at the forefront in China.Most part of patients are elderly. Concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal squamous cell carcinoma. Most elderly patients 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 squamous cell carcinoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multicenter, single-arm, phase Ⅱ clinical study to evaluate the efficacy and safety of radiotherapy alone followed by sequential injection of Toripalimab in elderly patients with unresectable esophageal squamous cell carcinoma who could not accept concurrent chemotherapy.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥75 years old, regardless of gender；
  2. Esophageal cancer confirmed by histology or cytology；
  3. Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy；
  4. Unable to tolerate chemotherapy；
  5. There are at least one lesions measurable according to RECIST 1.1；
  6. Stage II-iva (AJCC 8 TNM classification)
  7. Endoscopic ultrasonography confirmed that esophageal lesions did not invade adjacent organs (T1-4a).；
  8. ECOG PS 0-1；
  9. Forced expiratory volume (FEV) >0.8 liter；
  10. Life expectancy of at least 12 weeks；
  11. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, biotherapy，etc.
  12. Has sufficient organ function： (1) Blood routine: ANC≥1.5×109/L; PLT≥50×109/L; HGB≥90 g/L((No blood transfusion and blood products within 14 days, no use of G-CSF and other blood-stimulating factors to correct)) (2) Liver function: TBIL ≤ 1.5 × ULN，ALT、AST ≤2.5 × ULN， (3) Renal function: Cr≤1×ULN or crcl ≥50 ml/min (4) Adequate haemostasis laboratory data prior to randomization: INR or PT ≤1.5×ULN (If the subject was receiving anticoagulant therapy, as long as the PT was within the intended use range of anticoagulant drugs) (5) Myocardial enzymes were within the normal range.
  13. Patients voluntarily joined this study, signed informed consent and provided diagnosis and treatment data after cancer diagnosis before entering the group, good compliance, and cooperation with follow-up visits;

Exclusion Criteria:

  1. 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;
  2. with multifocal primary esophageal cancer;
  3. The pathological diagnosis was esophageal small cell carcinoma, adenocarcinoma, or mixed carcinoma.
  4. Esophageal squamous cell carcinoma with active bleeding within 2 months of the primary lesion；
  5. Patients whose imaging has shown that the tumor has invaded the important blood vessels or the investigator judges that the tumor is likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study
  6. 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)
  7. Clinically significant cardiac disease or impaired cardiac function, such as: MeanQT interval corrected for heart rate (QTc) ≥470 ms, Congestive heart failure requiring treatment (New York Heart Association [NYHA] grade > 2), left ventricular ejection fraction (LVEF) <50% as determined by Echocardiography.
  8. Active infection or fever of unknown origin > 38.5 ° C during screening or before the first dose (tumor-related fever, as judged by the investigator, was eligible);
  9. Current pneumonitis or interstitial lung disease or history of pneumonitis or interstitial lung disease.
  10. Has had congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (HCR-RNA was higher than the detection limit of the analytical method);
  11. Previous treatment with another PD-1, PD-L1；
  12. Known hypersensitivity to macromolecular protein preparations or to any anti-PD-1 antibody component;；
  13. Immunosuppressive drugs used within 7 days 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); Systemic steroid doses of less than 10 mg of prednisone daily or its equivalent are allowed in patients receiving physiologic replacement steroid doses without autoimmune disease.
  14. if they had undergone major surgery patients must have fully recovered from surgery with no major ongoing safety issues before the experiment begins.
  15. Currently participating in an interventional clinical research treatment, or has received another investigational drug or used an investigational device within 4 weeks prior to the first administration of the drug.
  16. Live vaccine within 4 weeks prior to first dose (Cycle 1, Day 1); NOTE: Injectable inactivated viral vaccine against seasonal influenza is allowed; however, live attenuated influenza vaccine for intranasal administration is not allowed.
  17. The investigator considers it unsuitable for inclusion. Patients with uncontrollable seizures or loss of self-control due to mental illness. serious abnormal laboratory test results, family, or social factors, which may affect the safety of the subjects or the data collection.

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: Radiotherapy Sequential Toripalimab
Radiotherapy:Intensity-modulated radiotherapy (IMRT) Immunotherapy: Toripalimab
Radiation: Radiotherapy
95% PGTV56-60Gy/28-30 fractions, 2Gy/1 fractions; 95% PTV50.4-54Gy/28-30 fractions, 1.8Gy/1 fractions; 5 days a week; 6 weeks.
Other Names:
  • Intensity-modulated radiotherapy (IMRT)
Drug: Toripalimab
Toripalimab (200 mg, intravenously infused) will be administered as the maintenance treatment every 3 weeks within 4 weeks after the completion of radiotherapy for 1 years or until progression, intolerable toxicity, or physician/patient decision
Other Names:
  • Immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 2 years
We aim to evaluate the progression-free survival (PFS) of elderly patients with unresectable esophageal squamous cell carcinoma who were unable to accept concurrent chemotherapy and received sequential treatment with Triptolide injection after radiotherapy alone.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 2 years
Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence .
2 years
Objective response rate (ORR)
Time Frame: 2 years
Objective response rate (ORR) is defined as the proportion of patients with a complete response(CR) or partial response(PR) to treatment according to RECIST v1.1.
2 years
Duration of response (DOR)
Time Frame: 2 years
Duration of response (DOR) was determined from date of initial response to PD according to RECIST v1.1.
2 years
Time to death or distant metastasis (TTDM)
Time Frame: 2 years
Time to death or distant metastasis (TTDM) according to RECIST v1.1.
2 years

Collaborators and Investigators

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

Sponsor

The Central Hospital of Lishui City

Investigators

  • Principal Investigator: Zhifeng Tian, M.D, Lishui Municipal Central Hospital，Zhejiang，China

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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

June 30, 2026

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJLSRT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

participant number,age,gender

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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