Actively Recruiting
Camrelizumab in Combination With Apatinib Mesylate Plus Short-course Chemotherapy for Advanced ESCC
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2024-11-21
188
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of patients with advanced esophageal squamous cell carcinoma treated with camrelizumab combined with Apatinib mesylate plus short-course chemotherapy versus standard chemotherapy in first line
CONDITIONS
Official Title
Camrelizumab in Combination With Apatinib Mesylate Plus Short-course Chemotherapy for Advanced ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Histologically or cytologically confirmed esophageal squamous cell carcinoma that is unresectable locally advanced, recurrent, or metastatic
- No prior systemic antitumor therapy, except certain neoadjuvant/adjuvant or chemoradiotherapy with recurrence/progression after more than 6 months
- At least one measurable lesion per RECIST 1.1 criteria, not previously treated with local therapies
- Agree to provide tissue samples for biomarker analysis, preferably recent or archival tissue sections
- ECOG performance status 0 to 1
- Ability to swallow pills normally
- Expected survival of at least 12 weeks
- Adequate vital organ function with specified laboratory values and no recent use of blood component drugs or growth factors
- Use of medically approved contraception during treatment and for specified times after last doses
- Voluntary informed consent with good compliance and willingness to follow up
You will not qualify if you...
- Body mass index under 18.5 kg/m2 or weight loss over 10% within 2 months before screening
- Active hemoptysis within 3 weeks or tumor bleeding within 2 weeks before treatment
- Tumor invasion of adjacent organs with high risk of bleeding or fistula
- History of gastrointestinal perforation, fistula, recent intestinal obstruction, or need for esophageal stent
- Clinical symptoms requiring drainage of pleural, pericardial effusions, or ascites within 1 month before randomization
- Poorly controlled high blood pressure
- Allergies to study drugs or components
- Recent use of investigational drugs, anticancer therapy, vaccines, corticosteroids, immunosuppressants, or major surgery/trauma within specified timeframes
- Unresolved toxicity from previous antitumor therapy greater than Grade 1
- Central nervous system metastasis
- History of active autoimmune diseases except specified exceptions
- History of immunodeficiency, organ or bone marrow transplantation
- Poorly controlled cardiovascular diseases or symptoms
- Severe infections or active pulmonary inflammation within specified periods
- History of interstitial lung disease or non-infectious pneumonia
- Active or recent tuberculosis infection
- Active hepatitis B or C infection
- Significant bleeding symptoms or bleeding tendency
- Recent arteriovenous thrombosis events
- Known hereditary or acquired bleeding and clotting disorders
- Active ulcers, unhealed wounds, or fractures
- Significant proteinuria
- Recent use of strong CYP3A4 inducers or inhibitors
- Other malignancies within 5 years except certain low-risk cancers
- Pregnant or lactating women
- Other serious medical conditions, mental illness, or social factors affecting safety or data integrity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
F
Feng Wang, phD
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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