Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC

NCT06061146 | Recruiting Phase 2

• 1 other identifier: E20230954
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Esophageal Cancer

Keywords

Old Age; Esophageal Cancer; Tislelizumab; Concurrent Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  up to 2 years

Secondary Outcomes (4)

• OS

  up to 2 years

• ORR

  up to 2 years

• DoR

  up to 2 years

• AE

  up to 3 years

Study Arms (2)

Arm A

EXPERIMENTAL

Tislelizumab + 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

Drug: Arm A; Radiation: Arm A

Arm B

ACTIVE COMPARATOR

S1 + Radiotherapy Drug: S1 PO, 40\~60mg，BID（d1-14，d22-35，two cycles） Radiation: Radiation Concurrent Radiation, 1.8Gy/f, 28f

Drug: Arm B; Radiation: Arm B

Interventions

Arm A DRUG

anti-PD-1 immunotherapy

Also known as: Tislelizumab

Arm A

Arm B DRUG

chemotherapy

Also known as: S1

Arm B

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Sichuan Cancer Hospital and Research Institute: collaborator
• Shanxi Province Cancer Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Hunan Cancer Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40001034 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

tislelizumab; S 1 (combination); Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Wencheng Zhang, M.D

  Tian jin cancer hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wencheng Zhang, M.D.

CONTACT

02223340123; zhangwencheng@tjmuch.com

Ke Zhang, M.D

CONTACT

02223340123; zk110105@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 29, 2023
• Study Start: October 5, 2023
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)