Actively Recruiting
Penpulimab Plus Chemotherapy With or Without Anlotinib as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma A Randomized Two-Arm Clinical Study
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
This clinical trial studies advanced esophageal squamous cell carcinoma, focusing on evaluating Penpulimab combined with chemotherapy, with or without Anlotinib, as a first-line treatment. It is a phase II open-label randomized study designed to compare the effectiveness and safety of these treatments in patients with resectable advanced disease who have not previously received systemic therapy or have relapsed after prior treatments. Participants are divided into two groups. Group A receives Penpulimab plus chemotherapy and Anlotinib every 3 weeks for 4 to 6 cycles during initial treatment, followed by maintenance therapy with Anlotinib and Penpulimab every 3 weeks until disease progression or intolerance. Group B gets Penpulimab plus chemotherapy every 3 weeks for 4 to 6 cycles initially, then Penpulimab alone every 3 weeks for maintenance until progression, after which both Anlotinib and Penpulimab are given until progression or intolerance. During the study, participants undergo assessments including gene testing, PD-L1 expression analysis, and blood tests before treatment and at specific cycle intervals. Researchers monitor tumor response over up to approximately two years to measure objective response rate. Safety and disease progression are closely followed to evaluate treatment effects and tolerability throughout the study period.
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
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Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
W
wei wang
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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