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Esophageal Squamous Cell Carcinoma by AJCC V8 StagePhase 2TREENCT05791136

Immunotherapy After Radiotherapy in Elderly ESCC

A Phase 2 study testing Radiotherapy and Toripalimab in people with Esophageal Squamous Cell Carcinoma by AJCC V8 Stage, run by The Central Hospital of Lishui City.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 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. Read more about this study

Who is it for?
Ages 75 years and older
What is being tested?
Radiotherapy and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Apr 2023to 30 Jun 2026
Phase
Phase 2
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥75 years old, regardless of gender；
  • Esophageal cancer confirmed by histology or cytology；
  • Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy；
  • Unable to tolerate chemotherapy；
  • There are at least one lesions measurable according to RECIST 1.1；
  • Stage II-iva (AJCC 8 TNM classification)
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  • Endoscopic ultrasonography confirmed that esophageal lesions did not invade adjacent organs (T1-4a).；
  • ECOG PS 0-1；
  • Forced expiratory volume (FEV) >0.8 liter；
  • Life expectancy of at least 12 weeks；
  • Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, biotherapy，etc.
  • 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.
  • 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;

Who cannot join

  • 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;
  • with multifocal primary esophageal cancer;
  • The pathological diagnosis was esophageal small cell carcinoma, adenocarcinoma, or mixed carcinoma.
  • Esophageal squamous cell carcinoma with active bleeding within 2 months of the primary lesion；
  • 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
  • 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)
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  • 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.
  • 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);
  • Current pneumonitis or interstitial lung disease or history of pneumonitis or interstitial lung disease.
  • 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);
  • Previous treatment with another PD-1, PD-L1；
  • Known hypersensitivity to macromolecular protein preparations or to any anti-PD-1 antibody component;；
  • 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.
  • if they had undergone major surgery patients must have fully recovered from surgery with no major ongoing safety issues before the experiment begins.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

No sites are listed yet.

Zhifeng Tian, M.D contact

0578-2285350

tzf419@hotmail.com

Wencai Li, M.D contact

0578-2285250

liwencai2021@163.com

About this study

Official title: 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.

Read the 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.

Being tested
Radiotherapy, Toripalimab
Keywords
Esophageal Squamous Cell Carcinoma, PD-1, Elderly, Radiotherapy
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

    Also called Intensity-modulated radiotherapy (IMRT)

    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.

  • ToripalimabDrug

    Also called Immunotherapy

    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

Study groups in NCT05791136
Study groupRoleWhat they receive
Radiotherapy Sequential ToripalimabExperimentalRadiotherapy:Intensity-modulated radiotherapy (IMRT) Immunotherapy: Toripalimab
Receives: Radiation: Radiotherapy; Drug: Toripalimab

What is being measured

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

  1. Progression-free survival (PFS)

    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.

    Measured: 2 years

Secondary outcomes (4)

  1. Overall survival (OS)

    Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence .

    Measured: 2 years

  2. Objective response rate (ORR)

    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.

    Measured: 2 years

  3. Duration of response (DOR)

    Duration of response (DOR) was determined from date of initial response to PD according to RECIST v1.1.

    Measured: 2 years

  4. Time to death or distant metastasis (TTDM)

    Time to death or distant metastasis (TTDM) according to RECIST v1.1.

    Measured: 2 years

Timeline

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

  1. First posted30 Mar 2023
  2. Study startApr 2023 (estimated)
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Jun 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05791136
Sponsor's protocol ID
ZJLSRT-001
Acronym
TREE
Status last verified
Mar 2023
First submitted
17 Mar 2023
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: participant number,age,gender

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy and Toripalimab in people with Esophageal Squamous Cell Carcinoma by AJCC V8 Stage, run by The Central Hospital of Lishui City.

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 13 inclusion and 17 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 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Zhifeng Tian, M.D (0578-2285350, tzf419@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 2 years). 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 NCT05791136.

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 30 Mar 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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