Actively Recruiting
Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-12-30
100
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study.
CONDITIONS
Official Title
Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage III-IV esophageal squamous cell carcinoma not suitable for curative treatment
- No prior systemic treatment or relapse after adjuvant therapy/radical surgery/radiotherapy over 6 months ago
- At least one measurable lesion per RECIST 1.1 criteria
- Age between 18 and 75 years
- ECOG performance score 0-1 and expected survival over 3 months
- Ability to provide tumor specimens, oral swabs, and blood samples as required
- Adequate organ and bone marrow function as defined by blood counts and biochemical tests
- Women of childbearing age must use contraception from screening to 3 months after treatment and have a negative pregnancy test or meet criteria for no pregnancy risk
- Men must agree to use contraception or be surgically sterilized during and 8 weeks post treatment
- Voluntary informed consent and willingness to comply with study procedures
You will not qualify if you...
- Esophageal squamous cell carcinoma causing complete obstruction requiring interventional relief
- Ulcerative esophageal squamous cell carcinoma
- High risk of bleeding or perforation due to tumor invasion or fistula formation
- Lesions not reduced after radiotherapy without surgery
- Allergy to paclitaxel, cisplatin, or their ingredients
- Prior use of paclitaxel or cisplatin in adjuvant chemotherapy with relapse or metastasis within 6 months
- Previous anti-tumor immunotherapy or anti-angiogenesis targeted therapy
- Conditions affecting oral medication intake except those who can take dissolved Anlotinib
- Liver metastases burden over 50% of liver volume
- Severe uncontrolled diseases including cardiac, infections, liver disease, poorly controlled diabetes, or significant proteinuria
- Long-term unhealed wounds or fractures
- Active bleeding or recent significant hemorrhage
- Major surgery within 4 weeks before treatment or planned during study
- History of gastrointestinal perforation, fistula, or thrombotic events within 6 months
- Symptomatic central nervous system metastases or cancerous meningitis
- Significant ascites or pleural effusion causing respiratory dysfunction
- Active tuberculosis or interstitial lung disease requiring steroids
- Uncontrolled metabolic or systemic diseases increasing medical risks
- Significant malnutrition (BMI <13.6 kg/m2)
- History of psychotropic drug abuse or mental disorders
- Immunodeficiency including HIV or organ transplant history
- Other primary malignancies except certain fully remitted or treated types
- Pregnancy or breastfeeding
- Investigator's judgment that concomitant diseases endanger safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
W
wei wang
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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