Actively Recruiting
Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Esophageal Squamous Cell Carcinoma A Randomized, Multi-center Phase II Clinical Trial
Led by Zhejiang Cancer Hospital · Updated on 2024-07-16
191
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of sintilimab as a consolidation therapy in elderly patients aged 70 to 85 years with esophageal squamous cell carcinoma who did not experience disease progression after receiving concurrent chemoradiotherapy. This phase II, prospective, randomized, controlled, multicenter study aims to compare progression-free survival, overall survival, tumor response, toxicity, and quality of life between treatment groups. The study is sponsored by Zhejiang Cancer Hospital and focuses on patients who cannot tolerate or refuse surgery. Participants are divided into two groups based on minimal residual disease (MRD) status and randomized to receive either sintilimab or regular follow-up observation. Patients in the treatment group receive sintilimab intravenously every three weeks, with dosing based on weight: 3 mg/kg for those weighing less than 60 kg and 200 mg for those 60 kg or more. Treatment starts within 42 days after the last radiotherapy session and continues until disease progression, unacceptable toxicity, loss to follow-up, death, or investigator decision, with a maximum duration of 12 months. The observation group undergoes regular follow-up every three months for at least one year without additional anti-tumor treatments. During the study, participants will undergo regular assessments including monitoring for disease progression, survival status, tumor response, and side effects. The primary outcome measure is median progression-free survival. Secondary outcomes include overall survival, objective response rate, and duration of response, with follow-up planned for up to two years. Safety and quality of life will be evaluated throughout, and no other cancer treatments are allowed during the study period. Total participation duration varies depending on treatment response and follow-up.
CONDITIONS
Brief Title
Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed esophageal squamous cell carcinoma, clinically staged II-IVb
- Candidates for curative surgery who cannot tolerate or refuse surgery
- Age between 70 and 85 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Received intensity-modulated radiotherapy (IMRT) with total dose of 54Gy ± 10%
- Concurrent chemotherapy with single-agent S-1 synchronized with radiotherapy
- Completed last chemotherapy cycle before or with last radiotherapy session
- No disease progression after chemoradiotherapy (complete response, partial response, or stable disease)
- Recovery from previous treatment toxicities to grade 1 or baseline except hearing loss, hair loss, fatigue
- First dose within 42 days after chemoradiotherapy completion
- No esophageal perforation or active bleeding, no major invasion of trachea or blood vessels
- No interstitial pneumonia or history of interstitial pneumonia
- Forced expiratory volume in 1 second (FEV1) ≥ 0.8L
- Expected survival of at least 3 months
- Laboratory criteria: hemoglobin ≥ 90g/L, platelets ≥ 100×10^9/L, neutrophils ≥ 1.5×10^9/L
- Serum creatinine ≤ 1.5 times upper normal limit or creatinine clearance ≥ 40 mL/min
- Liver function tests within specified limits
- INR and APTT ≤ 1.5 times upper normal limit with stable anticoagulant therapy allowed
- Signed informed consent complying with hospital and ethical policies
You will not qualify if you...
- Prior esophageal cancer surgery or previous immune checkpoint inhibitor treatment
- Clinical stage cT1-3N1-2M0 suitable for surgery and requiring surgery
- Disease progression after chemoradiotherapy
- High risk of gastrointestinal bleeding, esophageal fistula, or perforation
- History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or uncontrolled acute lung conditions
- Poor nutrition with BMI less than 18.5 kg/m2 or PG-SGA score ≥ 9
- Inability to understand or comply with trial requirements
- Presence of hematogenous metastases
- Other malignant lesions except certain curable cancers
- Known severe allergic reactions to study treatments
- Participation in other clinical trials within 30 days
- Active or history of autoimmune diseases except some stable conditions
- History of immunodeficiency including HIV or organ transplant
- Uncontrolled heart conditions such as heart failure, unstable angina, recent myocardial infarction, or arrhythmias
- Active or recent pulmonary tuberculosis infection
- Active hepatitis B or C infections above specified viral levels
- Any other serious concurrent diseases or conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive sintilimab starting within 42 days after completing chemoradiotherapy and continue treatment until disease progression, intolerable toxicity, loss to follow-up, death, or up to 12 months.
Infusions every 3 weeks
Duration - Up to 12 months
Participants in the observation group receive regular follow-up and observation without active treatment.
Visits scheduled as per regular follow-up
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yang Yang, M.D.
W
Weizhen Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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