HRS-4642 with gemcitabine, albumin-bound paclitaxel and adebrelimab before and after surgery for pancreatic cancer

An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

This trial tests whether adding HRS-4642 to chemotherapy (gemcitabine plus albumin-bound paclitaxel) and adebrelimab helps people with resectable or borderline resectable pancreatic cancer when given before and after surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: prednisone, Adebrelimab
• Locations: 1 site (Shanghai)
• Trial ID: NCT07131514 on ClinicalTrials.gov

What this trial studies

This open-label, single-center Phase 2 trial combines investigational HRS-4642 with standard gemcitabine and albumin-bound paclitaxel (AG) plus adebrelimab as neoadjuvant and adjuvant therapy for resectable and borderline resectable pancreatic ductal adenocarcinoma. Eligible participants must have pathologic confirmation, at least one measurable lesion by RECIST v1.1, ECOG 0–1, and adequate organ function. The regimen pairs chemotherapy with investigational and immune agents, with primary attention to safety and surgical feasibility and secondary measures of tumor response and recurrence. Imaging and surgical decisions follow NCCN guidelines, and patients are monitored for adverse events throughout treatment and follow-up.

Who should consider this trial

Good fit: Adults aged 18–80 with pathologically confirmed pancreatic ductal adenocarcinoma that is resectable or borderline resectable, a measurable lesion, ECOG 0–1, and adequate organ and marrow function are the intended participants.

Not a fit: People with metastatic or unresectable disease, ECOG performance status greater than 1, significant organ dysfunction, or inability to undergo surgery or required follow-up are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could increase tumor shrinkage before surgery and reduce the risk of cancer returning after surgery.

How similar studies have performed: Previous trials combining chemotherapy with immune checkpoint agents in pancreatic cancer have shown limited benefit, so this specific combination with HRS-4642 is novel and exploratory.

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 \[HCVantibodies\] 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. 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. 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.

Where this trial is running

Shanghai

• Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Baiyong shen, Dr

Conditions: Pancreatic Cancer