Actively Recruiting
Efficacy and Safety of Penpulimab Combined With Anlotinib and Chemotherapy
Led by Xijing Hospital · Updated on 2024-09-19
194
Participants Needed
1
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a two arm, randomized, prospective, multicenter study on the perioperative treatment of locally advanced resectable esophageal cancer with penpulimab combined with anlotinib hydrochloride and chemotherapy.
CONDITIONS
Official Title
Efficacy and Safety of Penpulimab Combined With Anlotinib and Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Diagnosed with esophageal cancer confirmed by gastroscope or ultrasonic gastroscope biopsy
- Clinical stage ct2n1-3m0, ct3n0-3m0, or ct4n0-3m0, TNM stage II-IVA
- Non-cervical esophageal cancer
- No prior systemic or local treatment for esophageal cancer
- At least one measurable lesion for imaging evaluation of neoadjuvant therapy
- ECOG performance status 0-1
- Estimated survival of at least 12 months
- Normal function of major organs including thyroid, lung, bone marrow, liver, kidney, and heart
- Women of childbearing age must use reliable contraception and have a negative pregnancy test within 7 days before enrollment
- Men must use contraception or be surgically sterilized during the trial and for 8 weeks after last drug administration
- Voluntarily consented to participate, able to comply with study schedule and follow-up, and agree to regular blood and tissue sample collection
You will not qualify if you...
- History of other malignant tumors within last 5 years except cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumor
- Ulcerative esophageal squamous cell carcinoma
- Esophageal or tracheal fistula
- Sensitivity to anlotinib, pembrolizumab, albumin paclitaxel, oxaliplatin, or excipients
- History of immune deficiency including HIV or organ transplantation
- Severe or uncontrolled diseases including uncontrolled high blood pressure, myocardial ischemia or infarction grade I or above, arrhythmia, cardiac insufficiency, poorly controlled diabetes, active severe infection, decompensated liver disease, active hepatitis B or C, hyperthyroidism, hypothyroidism, active tuberculosis
- Unresolved toxic reactions above grade 1 except hair loss
- Active bleeding in esophageal cancer within 2 months
- Tumor invasion of or risk to important blood vessels causing fatal hemorrhage
- Multiple factors impairing oral drug intake except dysphagia allowing water intake
- Urine protein ≥ ++ or 24-hour urine protein >1.0 g
- Major surgery, biopsy, or traumatic injury within 28 days before grouping
- Abnormal coagulation or bleeding tendency, recent severe bleeding events or unhealed wounds
- Arterial or venous thrombotic events within 6 months
- Pregnant or lactating women
- Distant metastasis
- Significant myelosuppression
- History of mental illness or psychotropic drug abuse
- Participation in other drug clinical trials within 4 weeks
- Other serious concomitant diseases or conditions judged unsuitable by investigator
- Investigator's judgment of unsuitability for inclusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaan'xi, China, 710000
Actively Recruiting
Research Team
L
Liu Hong, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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