Actively Recruiting
Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-06-28
20
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pancreatic cancer is a kind of digestive system tumor with extremely high malignancy and poor prognosis. Although the trend of benefit from immunotherapy in combination with chemotherapy is currently reflected in several exploratory studies, the overall efficacy is still relatively limited. Dysregulation of epigenetic mechanisms, which is common in cancer, leads to down-regulation of genes involved in tumor antigen processing or presentation, resulting in immune evasion and thus affecting the efficacy of immunotherapy. Epigenetic inhibitors may enhance the efficacy of immunotherapy by enhancing antigenicity and presentation of tumor-associated antigens, reprogramming the tumor microenvironment to counteract immunosuppression, and reversing cytotoxic T-cell depletion. Thus, decitabine-promoted immunotherapeutic sensitization is a potential therapeutic avenue for mPDAC patients that warrants further exploration in clinical trials. Taking into account the characteristics of pancreatic cancer immunophenotype, exploring combination therapy regimens that enhance anti-tumor immune response and improve the efficacy of immunotherapy has become an urgent clinical problem. This study is a prospective, single-arm, single-center, phase IB/II clinical study exploring the efficacy and safety of adebrelimab in combination with decitabine, albumin-bound paclitaxel, and gemcitabine in the first-line treatment of metastatic pancreatic cancer. The primary study endpoints are DLT, RP2D and ORR. Secondary study endpoints are OS, PFS, DCR, DoR and safety.
CONDITIONS
Official Title
Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Diagnosis confirmed by histology or cytology as pancreatic cancer from the pancreatic ductal epithelium with metastatic stage IV
- No previous anti-tumor therapy including chemotherapy, targeted therapy, or immunotherapy
- At least one measurable lesion per RECIST v1.1 criteria not previously treated with localized therapy unless progression is confirmed
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Expected survival of at least 3 months
- Adequate major organ function based on specific blood, liver, kidney, coagulation, heart rhythm, and heart function tests
- Negative pregnancy test for women of childbearing potential and agreement to use contraception during and after the study; men must also agree to appropriate contraception
- Voluntary signed informed consent to participate
You will not qualify if you...
- Pancreatic cancers originating from non-ductal epithelium such as neuroendocrine carcinoma or solid-pseudopapillary tumors
- Known central nervous system metastases
- Severe gastrointestinal dysfunction including bleeding, obstruction, or inflammation above specified grades
- Unstable third space fluid such as massive pleural effusion not manageable by drainage
- Clinically symptomatic ascites requiring drainage within 3 months
- Active or prior interstitial lung disease or pneumonia requiring treatment
- Active autoimmune diseases or history of autoimmune diseases prone to relapse except controlled conditions
- Peripheral neuropathy grade 3 or higher
- Serious infections within 4 weeks prior to enrollment
- Recent immunosuppressive or systemic hormone therapy, radiation therapy, major surgery, or other clinical study medications within specified timeframes
- Abnormal coagulation or bleeding disorders except low-dose aspirin or low molecular weight heparin use
- Uncontrolled cardiac conditions including heart failure, unstable angina, recent myocardial infarction, or serious arrhythmias
- Malignancies other than pancreatic cancer within 5 years except certain treated skin or cervical cancers
- Known allergies to study drugs or their components
- Known HIV, AIDS, or active syphilis infections
- History of neurological or psychiatric conditions such as epilepsy or dementia
- Other factors deemed by investigators to interfere with study participation or data collection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
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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