HRS-4642 with gemcitabine and albumin-bound paclitaxel as pre- and post-surgery treatment for pancreatic cancer

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

This trial will test whether adding HRS-4642 to gemcitabine and albumin-bound paclitaxel helps people with resectable or borderline resectable pancreatic ductal adenocarcinoma when given before and after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06587061 on ClinicalTrials.gov

What this trial studies

This open-label, single-center phase 2 trial gives HRS-4642 together with gemcitabine and albumin-bound paclitaxel (AG) as neoadjuvant therapy prior to surgery and as adjuvant therapy afterward for patients with resectable or borderline resectable pancreatic ductal adenocarcinoma. Eligible participants must have at least one measurable lesion and good performance status (ECOG 0–1) and adequate organ function. The study primarily monitors safety and collects preliminary efficacy signals such as tumor response, rates of complete surgical resection, and postoperative outcomes. Findings are intended to inform whether larger trials of this combination are warranted.

Who should consider this trial

Good fit: Adults aged 18–80 with pathologically confirmed pancreatic ductal adenocarcinoma that is resectable or borderline resectable by NCCN criteria, with at least one measurable lesion, ECOG 0–1, and adequate marrow and organ function are ideal candidates.

Not a fit: Patients with locally advanced unresectable or metastatic disease, poor performance status, significant organ dysfunction, or those unable to travel to the study center are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could increase tumor shrinkage before surgery, improve rates of complete surgical removal, and reduce the risk of cancer recurrence after surgery.

How similar studies have performed: Gemcitabine plus albumin-bound paclitaxel is an established chemotherapy combination, but combining it with the investigational agent HRS-4642 is novel and has limited prior clinical data.

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. Other situations that the researcher felt should not be included.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Conditions Pancreatic Cancer