Actively Recruiting
Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy
Led by Ruijin Hospital · Updated on 2025-12-29
20
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study explores the efficacy and safety of cryoablation combined with the dual-function antibody PD-1/CTLA-4 (Apalulizumab) for the treatment of locally advanced pancreatic cancer following failure of first-line AG therapy. This research aims to accumulate more clinical evidence and treatment options for second-line therapy in locally advanced pancreatic cancer following failure of first-line regimen.
CONDITIONS
Official Title
Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and above, with no gender restrictions
- Pathologically confirmed pancreatic cancer originating from the pancreatic ductal epithelium, with locally advanced disease
- Previous failure of standard AG chemotherapy treatment (at least one cycle received with disease progression or intolerance)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Adequate organ function including neutrophils 1.5 109 /L, white blood cells 3.0 109 /L, platelets 85 109 /L, hemoglobin 70 g/L
- Biochemical tests within specified limits including total bilirubin 2 times upper limit of normal (ULN), liver enzymes AST and ALT 5 times ULN in metastatic patients, albumin 28 g/L, and creatinine clearance rate 60 ml/min
- Cardiac function with normal or clinically insignificant ECG abnormalities and left ventricular ejection fraction (LVEF) above lower normal limit
- At least 3 weeks since surgery, radiotherapy, chemotherapy, or other anti-tumor treatments with recovery or stabilization of adverse effects to grade 1 or less
- Willingness to participate, sign informed consent, comply with follow-up, and good compliance
You will not qualify if you...
- Metastatic pancreatic cancer or previous interventional treatment for pancreatic cancer
- Presence of ascites requiring clinical intervention or unstable ascites
- Severe gastrointestinal diseases including bleeding, infection, perforation, obstruction, or diarrhea greater than grade 1
- Pain score of 4 or higher after standardized analgesic treatment
- Second primary malignancy within 5 years except cured carcinoma in situ or certain skin cancers
- Uncontrolled cardiovascular or cerebrovascular diseases with symptoms including advanced heart failure, unstable angina, recent myocardial infarction or stroke, arrhythmias requiring treatment, or uncontrolled hypertension
- Active hepatitis B infection with high viral load
- Active infection or unexplained fever above 38.5 0C affecting participation
- Known allergy to components of irinotecan hydrochloride liposome, other liposomes, oxaliplatin, 5-FU, LV, or S-1
- Pregnant or breastfeeding women
- Women of childbearing potential with positive pregnancy test; all subjects must use contraception during and for 3 months after trial
- Other medical or social conditions affecting consent, participation, or results interpretation
- Estimated survival time of 3 months or less
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 2000010
Actively Recruiting
Research Team
Z
Zhongmin Wang, Doctor
CONTACT
J
Jingfeng Li, Doctor
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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