Actively Recruiting
Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2023-12-26
136
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
S
Sichuan Cancer Hospital and Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteered to participate and agree to follow-up visits
- Aged 70 to 90 years, male or female
- Histologically confirmed locally advanced esophageal squamous cell carcinoma (cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1 with supraclavicular lymph node metastasis)
- Clinically staged II to IVb, inoperable locally advanced cancer including non-resectable cases or those with contraindications or refusal of surgery
- ECOG performance status of 0 or 1
- Presence of measurable or non-measurable lesions according to RECIST 1.1
- No previous systemic anti-tumor therapy including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, or investigational agents
- Provide fresh or archived tumor tissue samples within 6 months for biomarker analysis
- Expected survival of at least 3 months
- Adequate hematologic function: ANC ≥1500/µl, platelets ≥100,000/µl, hemoglobin ≥9.0 g/dl or 5.6 mmol/l
- Adequate renal function: creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min if creatinine >1.5× ULN
- Adequate liver function: total bilirubin ≤1.5× ULN; ALT, AST, AKP ≤2.5× ULN; albumin ≥2.8 g/dl
- Adequate coagulation function: INR ≤1.5× ULN and APTT ≤1.5× ULN unless on anticoagulants within therapeutic range
- Provide documented informed consent
You will not qualify if you...
- Prior surgery for esophageal cancer
- Presence of esophageal fistulae caused by tumor infiltration
- Risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation
- Poor nutritional status with weight loss of 10% or more in the last 2 months without improvement after nutritional support
- Major surgery or severe trauma within 4 weeks before starting study treatment
- Uncontrollable pleural, pericardial effusion, or ascites requiring repeated drainage
- Previous or current treatment with anti-PD-1/PD-L1 antibodies, chemotherapy, radiotherapy, targeted therapy, or investigational agents within 4 weeks before study treatment
- Systemic corticosteroids over 10 mg prednisone equivalent daily or other immunosuppressive agents within 2 weeks before study treatment, except certain local or prophylactic uses
- Recent anti-tumor or live vaccines within 4 weeks before study treatment
- Active autoimmune diseases or history of significant autoimmune disease except stable hypothyroidism, type I diabetes, vitiligo, or childhood allergies not needing adult intervention
- Immunodeficiency conditions including positive HIV, organ transplantation, or bone marrow transplantation
- Uncontrolled cardiac disease such as NYHA class II or above heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Severe infections or active lung inflammation requiring hospitalization or antibiotics within 4 weeks before study treatment
- History of interstitial lung disease, non-infectious pneumonia, or severe pulmonary insufficiency
- Active or recent tuberculosis infection
- Active hepatitis B or C infection
- Significant electrolyte abnormalities not improving with treatment
- Known allergy or hypersensitivity to study drugs or components including tirilizumab, paclitaxel, or cisplatin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
W
Wencheng Zhang, M.D.
CONTACT
K
Ke Zhang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here