Status:
RECRUITING
Adjuvant Pancreatic Therapy Guided by MRD
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
GeneCast Biotechnology Co., Ltd.
Conditions:
Pancreatic Adenocarcinoma Resectable
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 appr...
Detailed Description
In pancreatic cancer, circulating tumor DNA (ctDNA) carries tumor-specific mutations (e.g., KRAS, TP53), which can be tracked using next-generation sequencing (NGS) technology to detect minimal residu...
Eligibility Criteria
Inclusion
- 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 used by the patient and one by their partner) during the study and for 4 months (for females) or 6 months (for males) after the last study treatment.
Exclusion
- 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 \< 30 ml/min) calculated using the Cockcroft-Gault equation. b) Absolute neutrophil count \< 1.5 × 10\^9/L. c) Platelet count \< 100 × 10\^9/L. d) Hemoglobin \< 90 g/L. e) Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \> 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 participation in the study or likely to affect compliance with the study protocol.
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
856 Patients enrolled
Trial Details
Trial ID
NCT06966440
Start Date
June 1 2025
End Date
June 1 2030
Last Update
July 15 2025
Active Locations (1)
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1
Ruijing Hospital
Shanghai, China