HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
Launched by RUIJIN HOSPITAL · Sep 4, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new treatment approach for patients with pancreatic cancer, specifically a type known as pancreatic ductal adenocarcinoma. The study aims to evaluate the safety and effectiveness of a drug called HRS-4642 when combined with two other medications, gemcitabine and albumin-bound paclitaxel. This treatment will be given both before and after surgery to see if it can improve outcomes for patients with certain stages of this cancer.
To participate in this trial, individuals must be between 18 and 75 years old and have a confirmed diagnosis of pancreatic cancer that is either borderline resectable (meaning it may still be surgically removed) or locally progressive. They should have a measurable tumor and be in good overall health, with a life expectancy of at least 12 weeks. Participants will need to sign consent forms and may need to take precautions if they are of childbearing age. The trial is not yet recruiting, so there will be more information available as it begins. Overall, this study hopes to find a promising new treatment that could help improve survival rates for those affected by pancreatic cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age: ≥18 and ≤80 years old, male or female;
- • 2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
- • 3. Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.
- • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- • 5. Life expectancy ≥ 12 weeks;
- • 6. Adequate marrow and organ function;
- • 7. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration;
- • 8. Patients volunteered to participate in this study and signed informed consent;
- Exclusion Criteria:
- • 1. Previously received any anti-tumor therapy;
- • 2. the presence of distant metastatic lesions diagnosed by imaging;
- • 3. Known hypersensitivity to the study drug or any of its components;
- • 4. previous or concurrent other malignant tumors;
- • 5. Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
- • 6. Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
- • 7. previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
- • 8. Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- • 9. with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
- • 10. with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen \[HBsAg\] test result at screening together with an HBVDNA test value of ≥10,000 copies/ml \[2000 IU/ml\]), active hepatitis C (hepatitis C virus antigen \[HCV-antibodies\] at screening), or active hepatitis C (hepatitis C virus antitoxin \[HCV-antibodies\] at screening).antibody \[HCV-Ab\] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;
- • 11. Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and/or lipase concentrations ≥3 times ULN (except when the investigator determines that abnormally elevated amylase and/or lipase are associated with pancreatic cancer);
- • 12. Arm 2: Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with asthma that has completely resolved in childhood and does not require any intervention in adulthood can be included; patients with asthma that requires medical intervention with bronchodilators cannot be Inclusion);
- • 13. Arm 2: Systemic treatment with corticosteroids (\>10 mg/day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose; inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses ≤10 mg/day of prednisone efficacy permitted in the absence of active autoimmune disease
- • 14. Other situations that the researcher felt should not be included.
About Ruijin Hospital
Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, is a leading medical institution in China recognized for its commitment to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, Ruijin Hospital integrates cutting-edge medical practices with rigorous scientific investigation. The hospital's multidisciplinary teams are dedicated to developing new therapeutic approaches, improving patient outcomes, and contributing to global medical knowledge. As a sponsor of clinical trials, Ruijin Hospital ensures adherence to the highest ethical standards and regulatory compliance, fostering an environment of collaboration and excellence in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported