Actively Recruiting
Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-04-01
32
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.
CONDITIONS
Official Title
Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Confirmed esophageal squamous cell carcinoma with locally advanced unresectable or distant metastasis
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Failed first-line immunotherapy combined with chemotherapy
- At least one measurable or unmeasurable lesion per RECIST V1.1 (excluding intracranial lesions alone)
- Ability to swallow study medications
- Adequate organ function including specific blood counts and liver, kidney function within defined limits
- Negative pregnancy test for women of reproductive age and agreement to use effective contraception
- Provided informed consent to participate
You will not qualify if you...
- Diagnosis of other cancers within the past 5 years except certain cured cancers
- Previous treatment with Adebrelimab, Apatinib, or Tegafur
- Use of Chinese anti-tumor medicine within 2 weeks or other anti-tumor therapy within 4 weeks prior
- Unresolved side effects from prior cancer therapies above grade 1
- Participation in other clinical trials within 4 weeks
- Major surgery within 4 weeks or planned during study
- Current use or recent discontinuation of CYP3A strong inhibitors or inducers
- Need for treatment of or uncontrolled central nervous system metastases
- High risk of severe bleeding or esophageal fistula
- Significant gastrointestinal problems affecting drug absorption
- Active gastrointestinal ulcers, bleeding, or perforation
- Recent serious heart conditions or unstable angina
- Recent thrombotic or embolic events or current blood thinner therapy
- Certain heart rhythm or function abnormalities
- Uncontrollable fluid build-up requiring repeated drainage
- Past or current lung disease or active pneumonia requiring steroid treatment
- Active infection or fever over 38.5°C within 2 weeks before enrollment
- Active hepatitis B or C infection
- Live vaccines within 4 weeks before or planned after enrollment
- Congenital or acquired immune deficiency including HIV
- History of organ or bone marrow transplant
- Any other serious acute or chronic illness deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510030
Actively Recruiting
Research Team
M
Minghui Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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