search
Back to results

Tirellizumab Plus Concurrent Chemoradiation in Older With ESCC (TCRTOE)

Primary Purpose

Esophageal Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Arm A
Arm A
Arm A
Arm B
Arm B
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Old Age, Esophageal Cancer, Tirellizumab, Concurrent Chemoradiotherapy

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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;

Sites / Locations

  • Tianjin Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Tirellizumab + 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

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

Outcomes

Primary Outcome Measures

PFS
progression-free survival

Secondary Outcome Measures

OS
overall survival
ORR
overall response rate
DoR
Duration of Response
AE
Adverse events

Full Information

First Posted
September 10, 2023
Last Updated
September 24, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Sichuan Cancer Hospital and Research Institute, Shanxi Province Cancer Hospital, Henan Cancer Hospital, Hunan Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT06061146
Brief Title
Tirellizumab Plus Concurrent Chemoradiation in Older With ESCC
Acronym
TCRTOE
Official Title
Tirellizumab 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 5, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Sichuan Cancer Hospital and Research Institute, Shanxi Province Cancer Hospital, Henan Cancer Hospital, Hunan Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (tirilizumab + radiotherapy + tigio) and concurrent chemoradiation group (radiotherapy + tigio). The treatment efficiency and safety will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Old Age, Esophageal Cancer, Tirellizumab, Concurrent Chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Tirellizumab + 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
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
S1 + Radiotherapy Drug: S1 PO, 40~60mg,BID(d1-14,d22-35,two cycles) Radiation: Radiation Concurrent Radiation, 1.8Gy/f, 28f
Intervention Type
Drug
Intervention Name(s)
Arm A
Other Intervention Name(s)
Tirellizumab
Intervention Description
anti-PD-1 immunotherapy
Intervention Type
Drug
Intervention Name(s)
Arm A
Other Intervention Name(s)
S1
Intervention Description
chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Arm A
Other Intervention Name(s)
Radiotherapy
Intervention Description
Radiation Concurrent Radiation, 1.8Gy/f, 28f
Intervention Type
Drug
Intervention Name(s)
Arm B
Other Intervention Name(s)
S1
Intervention Description
chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Arm B
Other Intervention Name(s)
Radiotherapy
Intervention Description
Radiation Concurrent Radiation, 1.8Gy/f, 28f
Primary Outcome Measure Information:
Title
PFS
Description
progression-free survival
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
up to 2 years
Title
ORR
Description
overall response rate
Time Frame
up to 2 years
Title
DoR
Description
Duration of Response
Time Frame
up to 2 years
Title
AE
Description
Adverse events
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wencheng Zhang, M.D.
Phone
02223340123
Ext
1121
Email
zhangwencheng@tjmuch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ke Zhang, M.D
Phone
02223340123
Ext
1111
Email
zk110105@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wencheng Zhang, M.D
Organizational Affiliation
Tian jin cancer hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Cheng, M.D.
Phone
02223340123
Ext
1121
Email
zhangwencheng@tjmuch.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tirellizumab Plus Concurrent Chemoradiation in Older With ESCC

We'll reach out to this number within 24 hrs