Actively Recruiting
A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Led by Shandong Boan Biotechnology Co., Ltd · Updated on 2024-09-19
510
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, multicenter, Phase 3 study to compare the efficacy and safety of LY01015 and Opdivo®（Nivolumab Injection）combined respectively with fluorouracil plus cisplatin in participants with unresectable advanced, recurrent or metastatic previously untreated esophageal squamous cell carcinoma.
CONDITIONS
Official Title
A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the informed consent form.
- Male or female aged 18 to 75 years.
- Histopathologically confirmed esophageal squamous cell carcinoma.
- Diagnosed with advanced or metastatic esophageal squamous cell carcinoma not suitable for curative approaches.
- No prior systemic anti-cancer therapy for progressive or metastatic disease; prior neoadjuvant, adjuvant, or definitive therapy allowed if last dose was over 24 weeks before recurrence.
- At least one measurable lesion per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Tumor tissue available for PD-L1 expression analysis with tumor proportion score ≥1%.
- Expected survival of at least 6 months.
- Adequate organ function at screening.
You will not qualify if you...
- Presence of symptomatic brain metastases, spinal compression, or meningeal metastasis; stable asymptomatic brain metastases allowed if corticosteroids not used in past 4 weeks.
- High risk of bleeding or fistula from tumor invasion to esophagus or adjacent organs.
- Near-complete esophageal obstruction confirmed by endoscopy requiring intervention or risk of perforation post-stent.
- Unstable conditions within 6 months before consent including unstable angina, recent myocardial infarction, significant heart failure, severe arrhythmia, cerebrovascular accident needing treatment, or poorly controlled systemic diseases.
- Prior treatment with PD-1, PD-L1, PD-L2, CD137, CTLA-4 agents or other checkpoint inhibitors.
- Prior cumulative cisplatin dose over 300 mg/m2 with less than 12 months since last dose.
- Receipt of live vaccine within 4 weeks before first dose or planned during study.
- Use of systemic chemotherapy, targeted therapy, immunosuppressants, immunostimulants, biological agents, Chinese herbal medicines for anti-tumor indications, Chinese patent drugs, or participation in interventional clinical study within 4 weeks prior to first dose.
- Other severe medical conditions or abnormalities that increase risks or interfere with study participation or results interpretation as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
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