Adebrelimab and chidamide with gemcitabine plus S-1 for advanced pancreatic cancer

A Single-Arm, Multicenter, Open, Phase II Clinical Study of Adebrelimab and Chidamide in Combination With Gemcitabine and S1 for the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer

This study will test whether adding the immunotherapy adebrelimab and the oral drug chidamide to standard chemotherapy (gemcitabine plus S-1) helps people with unresectable locally advanced or metastatic pancreatic cancer respond better or live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jinling Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Adebrelimab
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06584227 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, first-line interventional study combining adebrelimab and chidamide with a gemcitabine plus S-1 chemotherapy backbone in adults with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma. Eligible participants are 18–75 years old with ECOG 0–1, measurable disease, and no prior systemic therapy for the current stage. The trial will monitor tumor responses, survival outcomes, and safety/tolerability of the combination. Treatment is given at a single center with scheduled imaging and clinical assessments to track efficacy and adverse events.

Who should consider this trial

Good fit: Adults 18–75 with histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic cancer, ECOG performance status 0–1, at least one measurable lesion, and no prior systemic therapy for the current stage are ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), prior systemic therapy for the current stage, resectable disease, active uncontrolled comorbidities, or who are pregnant are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this combination could extend survival or increase response rates compared with current first-line chemotherapy alone.

How similar studies have performed: Immunotherapy alone has shown limited benefit in pancreatic ductal adenocarcinoma to date, and combining immunotherapy with HDAC inhibitors and chemotherapy remains experimental with only limited clinical data so far.

Eligibility criteria

Inclusion Criteria:

1. 18 to 75 years old;
2. 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);
3. 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;
4. There must be at least one measurable lesion as a target lesion (according to RECIST v1.1 standards);
5. ECOG(American Eastern Cancer Collaboration) Physical status score: 0\~1;
6. Expected survival ≥3 months;
7. The function of major organs is good (no blood components, cell growth factors, whitening drugs, platelet drugs, anemia correction drugs are allowed within 14 days before enrollment);
8. Women of childbearing age must have had a blood pregnancy test within 7 days prior to enrollment, with a negative result, and be willing to use an appropriate method of contraception during the trial period and for 6 months after the end of treatment. For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the study period and for 3 months after the end of treatment;
9. Voluntarily participate in the study and sign the informed consent;
10. Good compliance, agreed to cooperate with the survival follow-up.

Exclusion Criteria:

1\) Have received any of the following treatments:

1. Previous treatment with ICIs or HDACi;
2. Received the last anti-cancer treatment (including surgery, radiotherapy, etc.) within 4 weeks before enrollment;
3. Received any other investigational drug/device treatment within 4 weeks prior to enrollment;
4. 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.

8\) Malignancies other than pancreatic cancer prior to initial use of the investigational drug, except malignancies with a low risk of metastasis and risk of death (5-year survival \>90%), such as adequately treated cervical carcinoma in situ, skin basal cell or squamous cell carcinoma; 9) Co-active hepatitis B (HBV DNA≥2000IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive); 10) People with acquired immune deficiency syndrome (AIDS) or HIV positive, active syphilis infection; 11) A clear history of neurological or psychiatric disorders, including epilepsy or dementia: 12) Those planning to become pregnant, pregnant and lactating women; 13) In the investigator\'s judgment, the subject has other factors that may lead to the forced termination of the study, such as non-compliance with the protocol, other serious medical conditions (including mental illness) requiring combined treatment, serious abnormalities in laboratory test values, family or social factors that may affect the safety of the subject or the collection of trial data.

Where this trial is running

Nanjing, Jiangsu

• Jinling Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xiufeng Liu, Prof. M.D.

Conditions Pancreatic Cancer, Adult; Adebrelimab; Chidamide; Gemcitabine; S1; First-Line; Locally Advanced or Metastatic Pancreatic Cancer