Actively Recruiting
Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma
Led by Zhejiang Cancer Hospital · Updated on 2024-07-16
191
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a prospective, randomized, controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of sintilimab as consolidation therapy in elderly patients with esophageal cancer who did not progress after concurrent chemoradiotherapy. Patients aged 70-85 years with esophageal squamous cell carcinoma who did not progress after concurrent chemoradiotherapy and meet the inclusion criteria will be stratified according to MRD status (positive vs negative) and randomized in a 1:1 ratio into two groups: the treatment group receiving sintilimab (for patients with a weight \<60 kg: 3 mg/kg IV on Day 1 every 3 weeks; for patients with a weight ≥60 kg: 200 mg IV on Day 1 every 3 weeks) and the observation group receiving regular follow-up. Patients should receive the first dose within 42 days after completing the last radiotherapy session and continue treatment until disease progression, intolerable toxicity, loss to follow-up, death, or other circumstances where the investigator determines treatment should be discontinued, whichever occurs first. The maximum duration of sintilimab treatment is 12 months (from the start of treatment), while the observation group will be followed up every 3 months for at least one year. No other anti-tumor treatments are allowed during the study period. The study aims to compare the effects of the two treatment modalities on progression-free survival, overall survival, tumor response, toxicity reactions, and quality of life in elderly patients with esophageal cancer.
CONDITIONS
Official 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, clinical stage II-IVb
- Candidates for curative esophageal cancer surgery who cannot tolerate or refuse surgery
- Age between 70 and 85 years
- ECOG performance status of 0 or 1
- Received intensity-modulated radiotherapy (IMRT) with a total dose of 54Gy �b1 10%
- Concurrent chemotherapy with single-agent S-1 (70mg/m2) given days 1-14 and 29-42
- Last chemotherapy cycle completed before or with last radiotherapy session; no consolidation chemotherapy
- Disease status after chemoradiotherapy is complete response, partial response, or stable disease
- Toxicities from prior treatments recovered to grade 1 or baseline, except hearing loss, hair loss, fatigue
- First dose of study medication administered within 42 days after chemoradiotherapy
- No esophageal perforation, active bleeding, or major chest vessel invasion; no interstitial pneumonia or history thereof; FEV1 �b1 0.8L or more
- Expected survival of at least 3 months
- Laboratory values meeting specified hemoglobin, platelets, neutrophils, creatinine, bilirubin, liver enzymes, and coagulation criteria
- Signed informed consent form
You will not qualify if you...
- Prior esophageal cancer surgery or 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 pulmonary conditions
- Poor nutritional status (BMI < 18.5 kg/m2 or PG-SGA score �b1 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 treatment components
- Participation in other clinical trials within 30 days
- Active or history of autoimmune diseases except some stable conditions
- History of immunodeficiency or organ/bone marrow transplantation
- Uncontrolled heart diseases including certain heart failures, angina, recent myocardial infarction, or arrhythmias
- Active or recent pulmonary tuberculosis
- Active hepatitis B or C infection
- Any other serious concurrent diseases or conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yang Yang, M.D.
CONTACT
W
Weizhen Xu
CONTACT
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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