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New treatment option for Pancreatic Cancer
Official title HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
ClinicalTrials.gov ID: NCT06587061
What this study is testing
What is HRS-4642+AG?
HRS-4642+AG is an investigational medicine, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and efficacy of HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age: ≥18 and ≤80 years old, male or female;
- Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and people must have at least one measurable lesion as defined by...
- Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 12 weeks;
You likely can't join if
- Previously received any anti-tumor therapy;
- the presence of distant metastatic lesions diagnosed by imaging;
- Known hypersensitivity to the study drug or any of its components;
- previous or concurrent other malignant tumors;
- Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
- Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
See the full eligibility criteria
- Age: ≥18 and ≤80 years old, male or female;
- Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and people must have at least one measurable lesion as defined by RECIST v1.1;
- Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 12 weeks;
- Adequate marrow and organ function;
- 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...
- Patients volunteered to participate in this study and signed informed consent;
- Previously received any anti-tumor therapy;
- the presence of distant metastatic lesions diagnosed by imaging;
- Known hypersensitivity to the study drug or any of its components;
- previous or concurrent other malignant tumors;
- Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
- Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
- previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
- 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...
- 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);
- 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...
- 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...
- Other situations that the researcher felt should not be included.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.