HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Phase 2

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: HRS-4642

• Registration Number: NCT06587061
• Lead Sponsor: Ruijin Hospital

Brief Summary

To evaluate the safety and efficacy of HRS-4642 in combination with gemcitabine and albumin-bound paclitaxel for the neoadjuvant and adjuvant treatment of pancreatic ductal adenocarcinoma.

Detailed Description

This study is an open, single center, exploratory clinical trial aimed at evaluating the safety and efficacy of HRS-4642 in combination with gemcitabine and albumin-bound paclitaxel for the neoadjuvant and adjuvant treatment of pancreatic ductal adenocarcinoma.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Last Update Submitted: 2024-09-04
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06
• Study Start: 2024-10
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age: ≥18 and ≤75 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. Borderline resectable pancreatic cancer as defined by NCCN guidelines, locally progressive pancreatic cancer assessed by the investigator as potentially resectable, and high-risk 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;
12. Other situations that the researcher felt should not be included.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	HRS-4642	HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	From the first drug administration to within 30 days for the last dose	AEs are assessed by NCI-CTCAE v5.0
R0 resection rate	At the time of surgery	Number of Subjects Achieving R0 Removal as a Percentage of Subjects

Secondary Outcome Measures

Name	Time	Method
Total resection rate	At the time of surgery	Percentage of subjects who received surgical treatment as a proportion of all subjects
pathologic complete response (pCR)	At the time of surgery	Number of subjects achieving pCR as a percentage of subjects
major pathologic response (MPR)	At the time of surgery	Number of Subjects Achieving MPR as a Percentage of Subjects
Objective Response Rate (ORR)	Up to approximately 6 months	Evaluated by RECIST v1.1
Disease-free survival (DFS)	Up to approximately 6 months	The time from adjuvant therapy to the occurrence of disease recurrence (local recurrence or distant recurrence) or death from any cause in subjects achieving R0/R1 resection is counted as occurring first
Event-free survival (EFS)	Up to approximately 6 months	The time from the first dose of neoadjuvant therapy to the occurrence of any event; events include the occurrence of imaging disease progression (based on the date of the imaging test), the occurrence of disease recurrence (local recurrence or distant recurrence) after surgery, and death from any cause, based on the time of the first occurrence
Overall survival (OS)	Up to approximately 12 months	Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China