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Esophageal CancerPhase 2TCRTOENCT06061146

Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC

A Phase 2 study testing Arm A and Arm B in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma. Aim to find the difference in efficacy and safety between tirilizumab combined with concurrent chemoradiation and standard concurrent chemoradiation. Read more about this study

Who is it for?
Ages 70 to 90 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Arm A and Arm B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteChina
Study dates
5 Oct 2023to 1 Oct 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 70 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Volunteered to participate, cooperated with follow-up visits;
  • Aged ≥ 70 years, both male and female;
  • Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1(supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC );
  • Clinically staged as II-IVb inoperable locally advanced ESCC(including non-resectable, or with contraindications to or refusal of surgery);
  • ECOG performance status 0 or 1;
  • Presence of measurable and/or non-measurable lesions as defined by RECIST 1.1;
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  • Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents);
  • Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded [FFPE] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;
  • Expected survival ≥ 3 months;
  • Adequate hematologic function, defined as ANC ≥1500/μl, platelet count ≥100,000/μl and hemoglobin count ≥9.0 g/dl or ≥5.6 mmol/l;
  • Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL/min for those with creatinine levels >1.5× ULN (Calculated from the Cockcroft-Gault formula);
  • Adequate hepatic function, defined as total bilirubin ≤1.5× ULN and ALT/AST/AKP levels ≤2.5× ULN and albumin ≥2.8 g/dl;
  • Adequate coagulation function, defined as INR ≤1.5× ULN and APTT≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as INR is within the therapeutic range;
  • Documented informed consent.

Who cannot join

  • Surgery for esophageal cancer;
  • Esophageal fistulae due to infiltration of the primary tumour;
  • Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
  • Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
  • Major surgery or severe trauma within 4 weeks prior to first use of study drug;
  • Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
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  • Received or receiving any of the following treatments in the past:
  • Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;
  • Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
  • Systemic treatment with corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment(except for the use of corticosteroids for local inflammation of the oesophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor.Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses >10mg/day prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;
  • Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;
  • Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism);Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;
  • Diagnosis of immunodeficiency, including positive HIV test,other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
  • Diagnosis of uncontrolled cardiac clinical symptoms or disease such as a.NYHA II or above heart failure b.unstable angina c.myocardial infarction within 1 year d.clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
  • Severe infections (CTC AE > Grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;
  • History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;
  • Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;
  • Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);
  • Presence of abnormal sodium, potassium, and calcium laboratory test values greater than Grade 1 within 2 weeks prior to randomisation that do not improve with treatment;
  • Known hypersensitivity to large protein preparations, or to any of the components of tirilizumab, or anaphylaxis, hypersensitivity, or contraindication to paclitaxel or cisplatin or to any of the components used within their preparations;

Trial locations and contacts

1 site in 1 country.

Wencheng Zhang, M.D. contact

02223340123 ext. 1121

zhangwencheng@tjmuch.com

Ke Zhang, M.D contact

02223340123 ext. 1111

zk110105@163.com

China1 site, 1 recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Wen Cheng, M.D., 02223340123 ext. 1121, zhangwencheng@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: Tislelizumab Combined With Concurrent Chemoradiation Versus Concurrent Chemoradiation for Older Patients With Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Parallel-controlled, Multicenter Phase II Clinical Study

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma. Aim to find the difference in efficacy and safety between tirilizumab combined with concurrent chemoradiation and standard concurrent chemoradiation.

Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. Tirelizumab is the first-line and second-line standard treatment for advanced esophageal squamous carcinoma. However, the effect of tirilizumab combined with concurrent chemoradiation for elder with locally advanced esophageal squamous cell carcinoma is unkown.

In the study, the investigators plan to enroll 136 elderly subjects with locally advanced esophageal cancer from five hospitals in China. The enrolled patients will be randomly divided into two groups: tirilizumab combined with concurrent chemoradiation group (Tislelizumab + radiotherapy + tigio) and concurrent chemoradiation group (radiotherapy + tigio). The treatment efficiency and safety will be evaluated.

Being tested
Arm A, Arm B
Keywords
Old Age, Esophageal Cancer, Tislelizumab, Concurrent Chemoradiotherapy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Arm ADrug

    Also called Tislelizumab

    anti-PD-1 immunotherapy

  • Arm ADrug

    Also called S1

    chemotherapy

  • Arm ARadiation

    Also called Radiotherapy

    Radiation Concurrent Radiation, 1.8Gy/f, 28f

  • Arm BDrug

    Also called S1

    chemotherapy

  • Arm BRadiation

    Also called Radiotherapy

    Radiation Concurrent Radiation, 1.8Gy/f, 28f

Study groups in NCT06061146
Study groupRoleWhat they receive
Arm AExperimentalTislelizumab + S1 + Radiotherapy Drug: Tirellizumab IV infusion，200 mg/3w, for 1 year Drug: S1 PO, 40~60mg，BID（d1-14，d22-35，two cycles） Radiation: Radiation Concurrent Radiation, 1.8Gy/f, 28f
Receives: Drug: Arm A; Radiation: Arm A
Arm BActive comparatorS1 + Radiotherapy Drug: S1 PO, 40~60mg，BID（d1-14，d22-35，two cycles） Radiation: Radiation Concurrent Radiation, 1.8Gy/f, 28f
Receives: Drug: Arm B; Radiation: Arm B

What is being measured

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

  1. PFS

    progression-free survival

    Measured: up to 2 years

Secondary outcomes (4)

  1. OS

    overall survival

    Measured: up to 2 years

  2. ORR

    overall response rate

    Measured: up to 2 years

  3. DoR

    Duration of Response

    Measured: up to 2 years

  4. AE

    Adverse events

    Measured: up to 3 years

Timeline

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

  1. First posted29 Sep 2023
  2. Study start5 Oct 2023
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Oct 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06061146
Sponsor's protocol ID
E20230954
Acronym
TCRTOE
Status last verified
Sep 2023
First submitted
10 Sep 2023
Last updated
26 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang K, Wang Q, Cao J, Fan C, Shen W, Xiao Q, Ge X, Zhang T, Liu X, Chen X, Dong J, Li Z, Zheng Z, Yan C, Wang P, Pang Q, Zhang W. Tislelizumab plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy for elderly patients with inoperable locally advanced esophageal squamous cell carcinoma: a multicenter, randomized, parallel-controlled, phase II clinical trial. BMC Cancer. 2025 Feb 25;25(1):347. doi: 10.1186/s12885-025-13758-0.

    PubMed 40001034

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arm A and Arm B in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 14 inclusion and 20 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 26 Dec 2023. 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.

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 Wencheng Zhang, M.D. (02223340123 ext. 1121, zhangwencheng@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: up to 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 NCT06061146, which also lists 1 linked publication.

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 26 Dec 2023.

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