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New treatment option for Advanced Liver Cancers
Official title A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)
ClinicalTrials.gov ID: NCT05098197
What this study is testing
What is Tumor Infiltrating Lymphocyte?
Tumor Infiltrating Lymphocyte is an investigational medicine, being studied as a potential treatment for advanced liver cancers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced hepatobiliary-pancreatic cancers. Autologous TILs are expanded from tumor resections or biopsies and infused i.v.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age: 18 years to 75 years;
- Histologically diagnosed as primary/relapsed/metastasized hepatobiliary cancer or pancreatic cancers;
- Expected life-span more than 3 months;
- Karnofsky≥60% or ECOG score 0-2;
- Test people have failed standard treatment regimens, or there are no standard treatment regimens available.
You likely can't join if
- Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring...
- Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
- Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart...
- Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive)...
- Severe physical or mental diseases;
- Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
See the full eligibility criteria
- Age: 18 years to 75 years;
- Histologically diagnosed as primary/relapsed/metastasized hepatobiliary cancer or pancreatic cancers;
- Expected life-span more than 3 months;
- Karnofsky≥60% or ECOG score 0-2;
- Test people have failed standard treatment regimens, or there are no standard treatment regimens available.
- Test people 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(people with liver metastasis ≤3×ULN);
- Totol bilirubin≤1.5×ULN;
- no absolute or relative contraindications to operation or biopsy;
- Test people 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 cease 28 days before obtaining TILs;
- Be able to understand and sign the informed consent document;
- Be able to stick to follow-up visit plan and other requirements in the agreement.
- Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
- Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
- Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable...
- Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
- Severe physical or mental diseases;
- Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
- Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
- History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
- Having received immunotherapy and developed irAE level greater than Level 3;
- Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
- Females in pregnancy or lactation;
- History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
- Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.