TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophag… (NCT06532799) | Clinical Trial Compass
RecruitingPhase 1/2
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer
China75 participantsStarted 2024-09-10
Plain-language summary
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.
Who can participate
Age range
16 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 16 years to 90 years
* Histologically diagnosed as primary/relapsed/metastasized Cancer
* Expected life span more than 3 months
* Karnofsky≥60% or ECOG score 0-2
* Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
* Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated
* At least 1 evaluable tumor lesion
* Hematology and Chemistry(within 7 days prior to enrollment):
* Absolute count of white blood cells≥2.5×10\^9/L
* Absolute count of neutropils≥1.5×10\^9/L
* Absolute count of lymphocytes ≥0.7×109/L
* Platelet count≥100×10\^9
* hemoglobin≥90 g/L
* Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)
* International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)
* Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min
* Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN)
* Totol bilirubin≤1.5×ULN
* No absolute or relative contraindications to operation or biopsy
* Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion
* Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.