Esophageal Squamous Cell CarcinomaPhase 4TINESNCT05603065
Tislelizumab With Chemotherapy or Radiation for Neoadjuvant Therapy of Esophageal Squamous Cell Carcinoma (TINES)
A Phase 4 study testing Tislelizumab + cisplatin + paclitaxel and Tislelizumab + radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Esophageal squamous cell carcinoma (ESCC), one of the most common subtypes of esophageal cancer, has a poor prognosis and low 5-year overall survival. At present, the treatment of ESCC includes chemotherapy, immunity, radiotherapy, surgery and other methods, and in recent years, the treatment regimen of immune… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Tislelizumab + cisplatin + paclitaxel and Tislelizumab + radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2022to Oct 2024
- Phase
- Phase 4
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) The subjects voluntarily joined the study and signed the informed consent form, with good compliance and follow-up;
- (2) 18 years old≤ age≤ 79 years old, male or female;
- (3) ECOG score 0~1 points;
- (4) Patients with pathological (histological or cytology) confirmed esophageal squaf cell carcinoma; According to the eighth edition of the clinical tumor TNM stage, subjects were resectable cT2-4aNanyM0;
- (5) Have measurable lesions (according to RECIST 1.1 criteria, tumor lesion CT scan length diameter≥ 10mm lymph node lesion CT scan short diameter ≥15mm);
- (6) Those who were first diagnosed with esophageal squamous cell carcinoma before enrollment and did not undergo radiotherapy, chemotherapy, immunity, surgery and targeted therapy;
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- (7) Able to eat a liquid diet or above, no signs before esophageal perforation or esophageal ulcers, and able to tolerate surgery;
- (8) The main organs function normally, that is, meet the following standards:
- Routine blood examination must be consistent (no blood transfusion, no hematopoietic factor and no correction with drugs within 14 days): ANC≥1.5×109/L; PLT≥100×109；HB≥90g/L；
- Biochemical tests must meet the following standards: TBIL≤1.5×ULN; ALT、AST≤2.5×ULN； serum creatinine sCr≤1.5×ULN, endogenous creatinine clearance≥50mL/min (Cockcroft-Gault formula); ALB≥30g/L；
- The coagulation function must meet: INR≤1.5×ULN and APTT≤1.5×ULN;
- Normal or mild to moderate lung function and can tolerate esophageal cancer surgery. Preoperative lung function examination should meet: VC% > 60%; FEV1 > 1.2 L，FEV1% > 40%； DLco>40%。
Who cannot join
- (1) Have any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy)); Patients with vitiligo or childhood asthma that have been in complete remission and do not require any intervention in adulthood are excluded, but patients requiring medical intervention with bronchodilators are not included;
- (2) Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co-infection with hepatitis B and C;
- (3) immunosuppressive drugs have been used within 14 days prior to first use of study drug, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., not more than 10mg/day prednisone or its equivalent);
- (4) The patient lost ≥ 10% body weight within 6 months before enrollment, or the BMI < 18.5kg/m2, or PG-SGA reached grade C;
- (5) Live attenuated vaccine within 4 weeks prior to the first dose or planned for the duration of the study;
- (6) other malignant tumors in the past 3 years;
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- (7) uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite optimal medical therapy); Patients with a new diagnosis of angina within 3 months prior to screening or myocardial infarction events within 6 months prior to screening; Arrhythmias (including QTcF: ≥450ms for men and 470ms ≥ women) require long-term use of antiarrhythmic drugs and grade II cardiac insufficiency ≥ New York Heart Association;
- (8) Those with a history of severe lung or heart disease;
- (9) Complicated by severe infection (eg, requiring intravenous antibiotics, antifungal or antiviral drugs) within 4 weeks before the first dose, or unexplained fever >38.5°C during screening/before the first dose;
- (10) Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- (11) Pregnant or lactating women; Patients of childbearing potential who are unwilling or unable to use effective contraception;
- (12) Known allergic reactions, hypersensitivity reactions or intolerances to investigational drugs and their excipients;
- (13) Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or who have 5 half-lives of the study drug;
- (14) Subject has a known history of psychotropic substance abuse, alcohol or drug abuse;
- (15) Any condition that the investigator believes is likely to harm the subject or cause the subject to be unable to meet or perform the study requirements;
- (16) After neoadjuvant therapy, the patient cannot tolerate surgery or is not suitable for surgery due to the progression of the disease.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: A Randomized, Open-label, Uncontrolled Study of Tislelizumab in Combination With Chemotherapy or Radiation Therapy for Neoadjuvant Therapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma (TINES)
Esophageal squamous cell carcinoma (ESCC), one of the most common subtypes of esophageal cancer, has a poor prognosis and low 5-year overall survival. At present, the treatment of ESCC includes chemotherapy, immunity, radiotherapy, surgery and other methods, and in recent years, the treatment regimen of immune combined chemotherapy has begun to show results in the treatment of esophageal cancer. Tislelizumab has demonstrated good efficacy in advanced esophageal cancer and in the second- and third-line treatment. At present, neoadjuvant immunization is carried out less, and neoadjuvant immunization plus chemoradiotherapy has been achieved With a pCR rate of 55.6 and AEs of grade III and above 65%, and studies have shown that radiotherapy has immunosensitizing and coordinating effects, whether immunotherapy combined with radiotherapy has a better efficacy is worth further investigation. This review intends to conduct a randomized, open-label, uncontrolled study of tislelizumab in combination with chemotherapy or radiation therapy for neoadjuvant therapy for resectable locally advanced thoracic esophageal squamous cell carcinoma with a view to providing a new option for resectable locally advanced ESCC.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Tislelizumab + cisplatin + paclitaxel, Tislelizumab + radiotherapy
- Keywords
- Tislelizumab, Neoadjuvant therapy, Immunotherapy, Esophageal squamous cell carcinoma
- 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.
Tislelizumab + cisplatin + paclitaxelDrug
Tislelizumab 200mgD1 + cisplatin 75mg/m^2D1 + paclitaxel 150mg/m^2D1 Q3W 3 cycles
Tislelizumab + radiotherapyDrug
Tislelizumab 200mgQ3W 3 cycles + radiotherapy (23 times in total, 1.8 Gy per dose, 5 times a week)
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Active comparator | Not described Receives: Drug: Tislelizumab + cisplatin + paclitaxel |
| Radiotherapy | Active comparator | Not described Receives: Drug: Tislelizumab + radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
postoperative pathological examination shows no carcinological tissue residue
Measured: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Secondary outcomes (7)
Primary pathologic response rate (MPR)
postoperative pathological examination shows a residual < of 10% of cancerous tissue
Measured: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Objective response rate (ORR) of primary lesions (RECIST v1.1)
the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time under imaging measurements, including complete response (CR, Complete Response) and partial response (PR, partial response) cases CR is defined as the complete disappearance of all target lesions except nodular disease. All target nodules must be reduced to normal size (minor axis< 10 mm). All target lesions must be evaluated.
PR is defined as the sum of the diameters of all measurable target lesions less than 30% ≥ baseline. The target nodule is summed and the short diameter is used, while all other target lesions are combined and the longest diameter is used. All target lesions must be evaluated.
Measured: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Disease-free survival (DFS)
the time between postoperative surgery and recurrence of disease or death (for any cause)
Measured: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Over all survival (OS)
the time from postoperative surgery to death (for any reason)
Measured: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Safety in the neoadjuvant phase and postoperative phase
according to the Common Acute and Subacute Toxicity Grading Standard (CTCAE 5.0), the adverse reactions after each immune combined radiotherapy or immune combined chemotherapy in the neoadjuvant therapy stage and the postoperative adverse reactions were evaluated
Measured: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Quality of life measurement and evaluation 1
according to the QLQ-C30 scale of the Quality of Life Survey, the quality of life after neoadjuvant therapy was assessed
Measured: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Quality of life measurement and evaluation 2
according to the QLQ-OES18 special scale for esophageal cancer, the quality of life after neoadjuvant therapy was assessed
Measured: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start10 Oct 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junke Fu, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603065
- Sponsor's protocol ID
- No. XJTU1AF2022LSK-374
- Acronym
- TINES
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Uncontrolled Study of Tislelizumab in Combination With Chemotherapy or Radiation Therapy for Neoadjuvant Therapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma (TINES)
- ClinicalTrials.gov ID
- NCT05603065
- Acronym / sponsor ID
- TINES / No. XJTU1AF2022LSK-374
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Tislelizumab, Neoadjuvant therapy, Immunotherapy, Esophageal squamous cell carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Esophageal squamous cell carcinoma (ESCC), one of the most common subtypes of esophageal cancer, has a poor prognosis and low 5-year overall survival. At present, the treatment of ESCC includes chemotherapy, immunity, radiotherapy, surgery and other methods, and in recent years, the treatment regimen of immune combined chemotherapy has begun to show results in the treatment of esophageal cancer. Tislelizumab has demonstrated good efficacy in advanced esophageal cancer and in the second- and third-line treatment. At present, neoadjuvant immunization is carried out less, and neoadjuvant immunization plus chemoradiotherapy has been achieved With a pCR rate of 55.6 and AEs of grade III and above 65%, and studies have shown that radiotherapy has immunosensitizing and coordinating effects, whether immunotherapy combined with radiotherapy has a better efficacy is worth further investigation. This review intends to conduct a randomized, open-label, uncontrolled study of tislelizumab in combination with chemotherapy or radiation therapy for neoadjuvant therapy for resectable locally advanced thoracic esophageal squamous cell carcinoma with a view to providing a new option for resectable locally advanced ESCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Active comparator | Drug: Tislelizumab + cisplatin + paclitaxel |
| Radiotherapy | Active comparator | Drug: Tislelizumab + radiotherapy |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- (1) The subjects voluntarily joined the study and signed the informed consent form, with good compliance and follow-up;
- (2) 18 years old≤ age≤ 79 years old, male or female;
- (3) ECOG score 0~1 points;
- (4) Patients with pathological (histological or cytology) confirmed esophageal squaf cell carcinoma; According to the eighth edition of the clinical tumor TNM stage, subjects were resectable cT2-4aNanyM0;
- (5) Have measurable lesions (according to RECIST 1.1 criteria, tumor lesion CT scan length diameter≥ 10mm lymph node lesion CT scan short diameter ≥15mm);
Key exclusion criteria (16 listed)
- (1) Have any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy)); Patients with vitiligo or childhood asthma that have been in complete remission and do not require any intervention in adulthood are excluded, but patients requiring medical intervention with bronchodilators are not included;
- (2) Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co-infection with hepatitis B and C;
- (3) immunosuppressive drugs have been used within 14 days prior to first use of study drug, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., not more than 10mg/day prednisone or its equivalent);
- (4) The patient lost ≥ 10% body weight within 6 months before enrollment, or the BMI < 18.5kg/m2, or PG-SGA reached grade C;
- (5) Live attenuated vaccine within 4 weeks prior to the first dose or planned for the duration of the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab + cisplatin + paclitaxelTislelizumab 200mgD1 + cisplatin 75mg/m^2D1 + paclitaxel 150mg/m^2D1 Q3W 3 cycles | Drug | Chemotherapy |
| Tislelizumab + radiotherapyTislelizumab 200mgQ3W 3 cycles + radiotherapy (23 times in total, 1.8 Gy per dose, 5 times a week) | Drug | Radiotherapy |
Primary outcome
Pathological complete response rate (pCR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
postoperative pathological examination shows no carcinological tissue residue
7 secondary outcomes
Primary pathologic response rate (MPR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Objective response rate (ORR) of primary lesions (RECIST v1.1)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Disease-free survival (DFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Over all survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Safety in the neoadjuvant phase and postoperative phase
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Quality of life measurement and evaluation 1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Quality of life measurement and evaluation 2
Time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junke Fu principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tislelizumab + cisplatin + paclitaxel and Tislelizumab + radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by First Affiliated Hospital Xi'an Jiaotong University 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 12 inclusion and 16 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 29 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: From date of randomization until the date of first documented progression or date of death from any cause whichever came first, up to 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2023.