Actively Recruiting
Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With 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
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Penpulimab plus chemotherapy, with or without Anlotinib, as a first-line treatment for patients with advanced esophageal squamous cell carcinoma who are not candidates for curative therapy. This phase II, open-label study aims to compare these two treatment approaches to better understand their effects on tumor response and patient outcomes. Participants will be randomly assigned to one of two groups. Group A will receive Penpulimab plus chemotherapy alongside Anlotinib every three weeks for 4 to 6 cycles during the initial treatment phase, followed by maintenance therapy with Anlotinib and Penpulimab every three weeks until disease progression or intolerance. Group B will receive Penpulimab plus chemotherapy every three weeks for 4 to 6 cycles initially, then Penpulimab maintenance every three weeks until disease progression, after which both Anlotinib and Penpulimab may be used until further progression or intolerance. Throughout the study, participants will undergo regular assessments including tumor measurements to evaluate the objective response rate over about two years. Other outcomes such as disease control, progression-free survival, overall survival, and quality of life changes will be monitored. Safety evaluations will include adverse event tracking. The study expects to follow patients up to three years, with ongoing monitoring to understand treatment effects and patient well-being during and after therapy.
CONDITIONS
Brief 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 treatment/surgery/radiotherapy over 6 months ago
- At least one measurable lesion per RECIST 1.1 criteria
- Age between 18 and 75 years
- ECOG performance status 0 to 1 with expected survival over 3 months
- Ability to provide tumor specimens and blood samples for testing
- Adequate organ and bone marrow function meeting specific laboratory criteria
- Women of childbearing potential must use contraception and have a negative pregnancy test
- Men must use contraception or have been surgically sterilized during the trial
- Voluntary participation with informed consent and willingness to comply with follow-up
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
- Primary lesion not reduced after radiotherapy without surgery
- Allergy to paclitaxel or cisplatin or their ingredients
- Relapse or metastasis within 6 months after adjuvant chemotherapy with paclitaxel or cisplatin
- Prior anti-tumor immunotherapy or anti-angiogenesis therapy
- Conditions affecting oral medication absorption, except those able to take dissolved Anlotinib
- Liver metastases burden over 50% of liver volume
- Severe uncontrolled diseases including certain heart conditions, infections, liver disease, poorly controlled diabetes, significant proteinuria
- Long-term unhealed wounds or fractures
- Recent active bleeding or bleeding tendency
- Major surgery within 4 weeks before study treatment
- History of gastrointestinal perforation or thrombotic events within 6 months
- Symptomatic central nervous system metastases or cancerous meningitis
- Significant ascites or pleural effusion causing respiratory problems
- Active tuberculosis or interstitial lung disease requiring steroids
- Uncontrolled metabolic or systemic diseases increasing medical risk
- Significant malnutrition (BMI <13.6 kg/m2)
- History of psychotropic drug abuse or mental disorders
- History of immunodeficiency or organ transplantation
- Recent or active pregnancy or breastfeeding
- Other conditions that endanger safety or affect study completion as judged by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 to 6 cycles of 3 weeks each for initial treatment, then maintenance treatment continuing until disease progression or intolerance
Participants receive Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy. Group A receives Penpulimab, chemotherapy, and Anlotinib every 3 weeks for 4 to 6 cycles followed by maintenance treatment with Anlotinib and Penpulimab every 3 weeks until disease progression or intolerance. Group B receives Penpulimab plus chemotherapy every 3 weeks for 4 to 6 cycles followed by Penpulimab maintenance every 3 weeks until disease progression, with possible addition of Anlotinib and Penpulimab after progression.
Visits every 3 weeks during both initial and maintenance treatment
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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