NCT06916975Not yet recruitingPhase 2
Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
A Prospective, Single-Arm, Phase II Clinical Trial of Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to evaluate the efficacy and safety of adebrelimab combined with the AG regimen in patients with unresectable locally advanced or metastatic pancreatic cancer who have received at least one prior line of systemic therapy but have not undergone gemcitabine-based treatment.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 1 Apr 2025
- Start date
- 15 Apr 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Jin Xu
- Diseases
- Pancreatic cancer
- NCT number
- NCT06916975
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 46
- From 15 Apr 2025 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects have any complications requiring systemic treatment with corticosteroids such as prednisone (\> 10mg/ day) or have used immunosuppressive drugs within 14 days prior to initial administration;
- Subjects received tumor vaccines or other immune-activating antitumor drugs (such as interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to initial administration;
- Subjects are participating in another clinical trial or have received a drug intervention from another clinical trial within 4 weeks prior to the first dose;
- Prior allogeneic organ transplantation or hematopoietic stem cell transplantation;
Other illness
- The subject has any known active autoimmune disease;
- Subjects have other malignancies requiring treatment;
- Clinically significant cardiovascular disorders;
- Serologically confirmed HIV infection;
- Active hepatitis B (HBsAg-positive with HBV-DNA ≥10³ copies/mL). Active hepatitis C (HCV antibody-positive with detectable HCV RNA and requiring antiviral therapy);
- Known hypersensitivity to monoclonal antibodies or any component of adebrelimab;
- History of severe allergic reactions to gemcitabine or nab-paclitaxel;
Other
- Any situation that the investigator believes may compromise the validity of the trial or patient safety.
Who the study is looking for
- Sign informed consent;
- Aged 18-75 years (inclusive);
- Histologically or cytologically confirmed pancreatic cancer;
- Unresectable locally advanced or metastatic pancreatic cancer, as determined by the investigator;
- Disease progression after prior treatment with at least one systemic therapy;
- No previous immunotherapy;
- No previous gemcitabine-based chemotherapy;
- Have at least one measurable lesion (according to RECIST 1.1 criteria);
- ECOG 0\~1;
- The estimated survival time is greater than 3 months;
- Adequate Organ Function (within 28 days prior to first dose): Hematology: White blood cell count (WBC) ≥3.0×10⁹/L Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelets (PLT) ≥100×10⁹/L Hemoglobin (HGB) ≥90 g/L Liver Function: Aspartate aminotransferase (AST) ≤2.5×ULN Alanine aminotransferase (ALT) ≤2.5×ULN Total bilirubin (TBIL) ≤1.5×ULN Renal Function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥60 mL/min (calculated via Cockcroft-Gault formula). Coagulation: International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Cardiac Function: No clinically significant abnormalities on electrocardiogram (ECG);
- Male subjects and females of childbearing potential must agree to use effective contraceptive measures from the first dose until 3 months after the last dose of the study drug.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.