Pancreatic cancer
Conditions
Interventions
single-arm:Intraluminal perfusion of adebrelimab+investigator’s choice of best treatment regimen
Sponsors
Eastern Theater General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age: above 18 years; 2.Subjects with pancreatic cancer confirmed by histology/cytology; 3.For tumor-related pleural or peritoneal effusion, hemorrhagic pleural or peritoneal effusion, the pathology or cytology of pleural/peritoneal effusion must confirm malignancy, and the pleural/peritoneal effusion must be moderate or above (>=4 cm), with clinical judgment indicating the need for intervention. 4.At least one measurable lesion according to RECIST 1.1 criteria; 5.ECOG performance status: 0–3; 6.Expected survival >= 2 months; 7.Major organ function must be normal, meeting the following criteria: 1)Hematology test criteria (no blood transfusion or blood products within 14 days, and no use of G-CSF or other hematopoietic stimulating factors for correction): HB >= 80 g/L; ANC >= 1.0 × 10?/L; PLT >= 50 × 10?/L; 2)Biochemical test criteria: TBIL 45 ml/min (Cockcroft-Gault formula); 8.Subjects with chronic HBV infection must receive antiviral therapy, and HBV DNA must be < 10,000 IU/mL; 9.Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must agree to use appropriate contraception during the study and for 8 weeks after the last dose of the investigational drug. Male subjects must agree to use appropriate contraception or have undergone surgical sterilization during the study and for 8 weeks after the last dose of the investigational drug; 10.Subjects must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Asymptomatic pleural or peritoneal effusion that does not require clinical intervention; 2.Contraindications to puncture therapy; 3.Contraindications to immunotherapy (including long-term use of corticosteroids, history of radiation pneumonitis, radiation hepatitis, radiation enteritis, etc.); 4.Active autoimmune diseases (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.); 5.Patients with hepatitis B combined with hepatitis C, active hepatitis C, HIV, syphilis infection, or active tuberculosis; 6.Severe active infections that are uncontrolled. Severe infections within 4 weeks prior to the first dose, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications; 7.Known history of allogeneic organ transplantation or autologous hematopoietic stem cell transplantation; 8.Past or current history of pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or severely impaired lung function; 9.History of psychiatric drug abuse that cannot be discontinued or psychiatric disorders; 10.Participation in another clinical trial involving anti-tumor drugs within 4 weeks prior; 11.Prior use of PD-1/PD-L1 monoclonal antibodies or other immunotherapy drugs via intrapleural/intraperitoneal administration; 12.Uncontrolled central nervous system metastases with manifestations of intracranial hypertension; 13.Bleeding tendency, especially significant gastrointestinal bleeding within 4 weeks; or currently receiving thrombolytic or anticoagulant therapy; 14.History of or concurrent untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer; 15.Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to adopt effective contraceptive measures; 16.Any other conditions deemed by the investigator as potentially affecting the conduct of the clinical study or the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;progression-free survival;disease control rate;Puncture free survival;Control rate of pleural/peritoneal effusion;Safety; | — |
Countries
China
Contacts
Public ContactXiaoyuan Chu, Xiufeng Liu
Eastern Theater General Hospital of the Chinese People's Liberation Army
Outcome results
None listed