Actively Recruiting
Phase Ib/II Study of Adebrelimab Combined with Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for 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
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Metastatic pancreatic cancer is a highly malignant tumor with a poor outlook. Current immunotherapy combined with chemotherapy shows limited overall effectiveness. This trial explores whether adding decitabine, an epigenetic inhibitor, can improve immunotherapy by enhancing tumor antigen presentation, altering the tumor environment, and boosting immune responses. The study focuses on evaluating the combination of adebrelimab with decitabine, albumin-bound paclitaxel, and gemcitabine as a first treatment for this cancer type. Participants receive a treatment cycle every 28 days including decitabine given by continuous infusion over 1 hour on days 1 to 3, albumin-bound paclitaxel at 125 mg/m2 infused intravenously on days 1, 8, and 15, and gemcitabine at 1000 mg/m2 intravenously on the same days. Adebrelimab is administered at 1200 mg by IV infusion on day 15 every 3 weeks. Dose adjustments for paclitaxel and gemcitabine may be made if treatment-related side effects occur. During the study, researchers monitor dose limiting toxicities, the recommended dose for phase 2, and the objective response rate for up to 12 months. Secondary measures include overall survival up to 2 years, progression-free survival up to 6 months, disease control rate, duration of response, and safety events. Participants undergo regular assessments to evaluate treatment effects and safety over the study period ending in November 2026.
CONDITIONS
Brief 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 18 to 75 years, male or female
- Confirmed diagnosis of metastatic pancreatic cancer from pancreatic ductal epithelium
- No prior anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, etc.)
- At least one measurable lesion not previously treated by radiotherapy or confirmed progression after radiotherapy
- ECOG performance status 0 to 1
- Expected survival of at least 3 months
- Adequate major organ function based on blood counts, liver, kidney, and heart tests
- Negative pregnancy test for women of childbearing potential and agreement to use contraception during and after treatment
- Voluntary informed consent to participate
You will not qualify if you...
- Pancreatic cancer from non-ductal origins (e.g., neuroendocrine carcinoma, pancreatoblastoma)
- Known brain metastases
- Severe gastrointestinal dysfunction (bleeding, obstruction, inflammation > grade 2, diarrhea > grade 1)
- Unstable third interstitial fluid such as large pleural effusion or symptomatic ascites requiring drainage
- Current or prior interstitial lung disease or active lung infections
- Active autoimmune diseases or history of relapse-prone autoimmune conditions requiring systemic immunosuppression
- Peripheral neuropathy grade 3 or higher
- Serious infections within 4 weeks before enrollment
- Recent immunosuppressive therapy, radiation, major surgery, or participation in other clinical trials within specified timeframes
- Abnormal blood clotting or bleeding disorders except low-dose aspirin or low molecular heparin
- Uncontrolled significant heart conditions
- Other malignancies within 5 years except certain skin or cervical cancers
- Known allergies to study drugs or their components
- HIV, AIDS, or active syphilis infection
- History of neurological or psychiatric disorders that may interfere with study participation
- Other factors judged by investigators to prevent safe or compliant 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 - Repeated 28-day cycles until disease progression or discontinuation
Participants receive a combination of Adebrelimab, Decitabine, Albumin-bound Paclitaxel, and Gemcitabine as first-line treatment for metastatic pancreatic cancer in repeated 28-day cycles.
Visits on Days 1, 8, and 15 of each 28-day cycle
Duration - Up to 12 months for response assessments and up to 2 years for overall survival monitoring
Participants are monitored for safety and treatment outcomes after completing treatment.
Periodic visits during follow-up period
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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