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Trial Title:
HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
NCT ID:
NCT06587061
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-4642
Description:
HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel will be
administrated per dose level in which the patients are assigned.
Arm group label:
Arm A
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Start date:
October 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06587061
