Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Hepatobiliary-Pancreatic Cancers
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shanghai Juncell Therapeutics
Lead Sponsor
S
Shanghai 10th People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of tumor infiltrating lymphocyte (TIL) therapy for patients with advanced hepatobiliary and pancreatic cancers. This early phase 1 study involves patients who have primary, relapsed, or metastasized liver or pancreatic cancers. The goal is to evaluate how well this treatment works and its impact on disease progression and survival over up to 36 months. Participants receive an infusion of their own expanded TILs, ranging from 1x10^9 to 5x10^10 cells, after a non-myeloablative lymphodepletion treatment that includes a single dose of hydroxychloroquine (600 mg) and cyclophosphamide. The TILs are prepared from tumor tissue or malignant fluids collected through biopsy or surgery. The infusion is given intravenously over 30 to 120 minutes. During the study, participants will be monitored for up to 36 months with regular assessments of adverse events, tumor response, disease control, duration of response, progression-free survival, and overall survival. Researchers will also evaluate changes in quality of life. Patients must be able to follow the visit schedule and attend follow-ups to assess treatment effects and safety over time.
CONDITIONS
Brief Title
A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically confirmed primary, relapsed, or metastatic hepatobiliary or pancreatic cancer
- Expected life span of more than 3 months
- Karnofsky score 60% or higher, or ECOG performance status 0 to 2
- Failed standard treatments or no available standard regimens
- Tumor regions suitable for biopsy or resection, or malignant body fluid for TIL isolation
- At least one tumor lesion that can be evaluated
- Hematology and chemistry lab values within 7 days prior to enrollment meeting specified thresholds
- No contraindications to operation or biopsy
- Willingness to use effective contraception if of child-bearing potential during and up to one year after lymphodepletion
- No tumor-targeting therapies within 28 days before TIL collection
- Ability to understand and sign informed consent
- Willingness to adhere to follow-up visit schedule and study requirements
You will not qualify if you...
- Need for glucocorticoid treatment with prednisone over 15 mg daily or immunomodulatory treatment for autoimmune diseases
- Forced expiratory volume in 1 second less than 2L or lung diffusion capacity less than 40%
- Severe cardiovascular conditions including NYHA class III or IV heart failure, uncontrolled low blood pressure, significant coronary artery disease, or ejection fraction below 35%
- HIV infection, active hepatitis B or C, syphilis infection
- Severe physical or mental illness
- Active systemic infection or positive blood cultures
- Current or recent treatment (within one month) with other medicines, biologics, chemotherapy, or radiotherapy
- Allergy history to chemicals or biologics similar to cell therapy
- History of severe immune-related adverse events from prior immunotherapy greater than grade 3
- Unresolved adverse events from previous anti-tumor treatment above grade 1 (except alopecia)
- Pregnancy or breastfeeding
- History of organ transplantation, stem cell transplantation, or renal replacement therapy
- Other severe systemic diseases or conditions deemed inappropriate by researchers for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with follow-up up to 36 months
Participants receive a non-myeloablative lymphodepletion treatment followed by an intravenous infusion of their own expanded tumor infiltrating lymphocytes (TILs).
1 treatment visit and multiple follow-up visits over 36 months
Duration - Up to 36 months
Participants are monitored for adverse events, tumor response, progression-free survival, overall survival, and quality of life after treatment.
Regular follow-up visits over 36 months
Trial Site Locations
Total: 1 location
1
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
C
Clinical GC
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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