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New treatment option for Pancreatic Adenocarcinoma Resectable
Official title Adjuvant Pancreatic Therapy Guided by MRD
ClinicalTrials.gov ID: NCT06966440
What this study is testing
What is adjuvant chemotherapy regimens?
adjuvant chemotherapy regimens is an investigational medicine, being studied as a potential treatment for pancreatic adenocarcinoma resectable.
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
- Pancreatic adenocarcinoma (PAAD) is a leading cause of cancer-related deaths worldwide. Although surgical resection can be curative, the 5-year overall survival (OS) rate after resection alone is approximately 20%.
- Which group you join is decided by chance.
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 75
You may be able to join if
- Capable of providing written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule
- Male or female aged 18-75 years at the time of ICF signing.
- Histologically confirmed pancreatic ductal adenocarcinoma, Stage I-III, and has undergone R0 resection.
- Time between surgery and randomization ≤ 12 weeks.
- ECOG PS 0-2.
You likely can't join if
- Other types of non-ductal pancreatic tumors, including neuroendocrine tumors or acinar cell carcinoma, cystadenocarcinoma, and ampullary carcinoma.
- Hepatic or renal dysfunction as follows, or if the investigator considers adjuvant chemotherapy to be clearly contraindicated: a) Moderate/severe...
- Pregnant or breastfeeding women.
- Any serious or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, active infection (including hepatitis B...
- Concurrent presence of another malignancy or a history of malignancy (except for adequately treated carcinoma in situ of the cervix, basal cell...
- Other conditions that the investigator deems unsuitable for participation in the study.
See the full eligibility criteria
- Capable of providing written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule
- Male or female aged 18-75 years at the time of ICF signing.
- Histologically confirmed pancreatic ductal adenocarcinoma, Stage I-III, and has undergone R0 resection.
- Time between surgery and randomization ≤ 12 weeks.
- ECOG PS 0-2.
- Fully recovered from surgery and able to receive adjuvant chemotherapy.
- Availability of sufficient tumor tissue for MRD testing.
- Patients with reproductive potential (female patients: must have entered the study after the menstrual period and with a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one...
- Other types of non-ductal pancreatic tumors, including neuroendocrine tumors or acinar cell carcinoma, cystadenocarcinoma, and ampullary carcinoma.
- Hepatic or renal dysfunction as follows, or if the investigator considers adjuvant chemotherapy to be clearly contraindicated: a) Moderate/severe renal impairment (GFR \ 2.5 × the upper limit of normal.
- Pregnant or breastfeeding women.
- Any serious or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, active infection (including hepatitis B, hepatitis C, HIV, etc.), which the investigator deems unsuitable for...
- Concurrent presence of another malignancy or a history of malignancy (except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin)
- Other conditions that the investigator deems unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.