Actively Recruiting
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer
Led by Essen Biotech · Updated on 2024-11-12
75
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory stomach and esophageal cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has shown significant promise in treating unresectable or metastatic melanoma by leveraging the patient's own immune cells to target and destroy cancer cells. This study aims to apply a similar approach to stomach and esophageal cancers. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.
CONDITIONS
Official Title
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 90 years
- Diagnosed with primary, relapsed, or metastatic stomach or esophageal cancer
- Expected to live more than 3 months
- Karnofsky score 60% or higher, or ECOG score between 0 and 2
- Have failed standard treatments or no standard treatments available
- Have tumor areas suitable for biopsy, surgery, or malignant fluid for TIL isolation
- At least one tumor lesion that can be evaluated
- Blood test results within 7 days before enrollment meeting specific counts for white blood cells, neutrophils, lymphocytes, platelets, hemoglobin, and normal clotting and liver/kidney function
- No contraindications for biopsy or surgery
- If able to have children, agree to use effective contraception during the study and for 1 year after lymphodepletion
- Stop any cancer-targeting treatments including chemotherapy, radiotherapy, or biologics at least 28 days before TIL collection
- Able to understand and sign informed consent
- Willing to follow study visit schedules and other requirements
You will not qualify if you...
- Need glucocorticoid treatment with daily prednisone over 15 mg or require immunomodulatory treatment for autoimmune diseases
- Lung function with forced expiratory volume in 1 second less than 2 liters or carbon monoxide diffusion less than 40%
- Severe heart problems such as advanced heart failure (NYHA III or IV), low blood pressure, serious coronary artery disease, low ejection fraction below 35%, or dangerous heart rhythm issues
- Positive for HIV, active hepatitis B or C, syphilis, or related infections
- Severe physical or mental illness
- Active infection needing treatment or positive blood cultures
- Receiving other medicines, biologics, chemotherapy, or radiotherapy within the past month or currently
- Allergic to substances similar to cell therapy
- Previous immunotherapy side effects worse than level 3
- Side effects from prior cancer treatments not resolved to grade 1 or lower (except mild alopecia)
- Pregnant or breastfeeding women
- History of organ transplant, stem cell transplant, or kidney replacement therapy
- Other severe systemic diseases or any reasons deemed unsuitable for the study by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
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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