Adebrelimab and Chidamide for Pancreatic Cancer
ConditionPancreatic Cancer, Adult
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLiu Xiufeng
About this trial
Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. The primary treatment regimen for advanced pancreatic cancer remains chemotherapy, which results in a median survival time of only 8 to 12 months. Therefore, there is an urgent need to explore new combination therapies to extend survival. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.
Eligibility criteria
Qualifiers
18 to 75 years old;
Histologically or cytologically confirmed pancreatic cancer (originating from the ductal epithelium of the pancreas) with clinically documented unresectable locally advanced or metastatic pancreatic cancer (stage III/IV according to the TNM stage of AJCC 8 pancreatic cancer);
have not previously received systematic antitumor therapy for the current stage of disease, including surgery (except stent placement), radiotherapy, chemotherapy, targeting, immunotherapy or investigational therapy;
There must be at least one measurable lesion as a target lesion (according to RECIST v1.1 standards);
Disqualifiers
Previous treatment with ICIs or HDACi;
Received the last anti-cancer treatment (including surgery, radiotherapy, etc.) within 4 weeks before enrollment;
Received any other investigational drug/device treatment within 4 weeks prior to enrollment;
Enrolling in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 2) Patients known to be allergic to the components of the investigational drug; 3) Patients with known central nervous system metastasis; 4) Severe gastrointestinal dysfunction (bleeding, severe inflammation, obstruction, or diarrhea greater than grade 2); 5) Serious infections (CTC AE> Grade 2) occurred within 4 weeks prior to enrollment, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc., and symptoms and signs of infection within 2 weeks prior to enrollment requiring intravenous antibiotic treatment (except for prophylactic antibiotic use); 6) Occurrence of arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within 1 year before enrollment; 7) Have clinical symptoms or heart diseases that are not well controlled, such as: (1)NYHA2 or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
Trial design
Treatments tested in this trial
- Adebrelimab and Chidamide Combined with Gemcitabine and S1
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Liu Xiufeng
Lead sponsor
Jinling Hospital, China
Sponsor institution
Source ClinicalTrials.gov