Clinical trial · Observational
Application of ctDNA in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer
A Single-center, Observational, Prospective Cohort Study of ctDNA Testing in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the value of ctDNA detection in the assessment of response rate to neoadjuvant chemotherapy in pancreatic cancer and to explore the correlation between ctDNA clearance and prognosis at different time points. Meanwhile, whole exome sequencing (WES) and RNA Sequencing (RNA-seq) of samples of responders and non-responders to neoadjuvant chemotherapy before and after treatment are performed to explore the mechanisms of drug resistance and provide guidance for clinical decision making.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Evaluation of Tumor Resectability Shall be Made in Consensus at Multidisciplinary Meetings, According to NCCN Guideline Version 1.2022 Pancreatic Adenocarcinoma | — | UNRESOLVED | — |
| Patients With Non-metastatic Pancreatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ctDNA detection group
- description
- ctDNA detection, WES and RNA-seq will be performed on blood samples of all patients in this group.
- interventionNames
- Diagnostic Test: ctDNA detection
Primary outcomes (1)
- measure
- Objective response rate (ORR) of neoadjuvant therapy in patients with non-metastatic pancreatic cancer
- timeFrame
- Up to 24 months
- description
- Pre-treatment ctDNA detection and mutation characterization in blood are used to evaluate objective response rate (ORR) of neoadjuvant therapy in patients with non-metastatic pancreatic cancer.
Secondary outcomes (6)
- measure
- Rate of adverse reactions
- timeFrame
- One week during therapy and 3 months thereafter up to 24 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed patients with non-metastatic pancreatic cancer; * The pathological features were identified as pancreatic ductal carcinoma; * Patients with clinical risk factors including significantly elevated CA19-9 levels at diagnosis, large primary tumor volume, large regional lymph node diameter, significant weight loss, and extreme pain; * Patients accept neoadjuvant chemotherapy voluntarily with the regimen of modified FOLFIRINOX, and disease evaluation should be conducted every two courses, surgery should be performed without delay if resection criteria have been met, and at least two courses of chemotherapy should be completed; * Age ≥18 years old; * No other tumor treatment within 4 weeks prior to enrollment; * Complete clinical data, including basic information, pathological information, treatment information; * The subjects voluntarily join the study and sign the informed consent with good compliance, and cooperate with the acquisition of tissue samples and regular blood samples. Exclusion Criteria: * Any other systemic antitumor therapy priorly; * Concomitant malignancies under treatment; * Patients with a history of allergy to relevant chemotherapy agents; * Failure to comply with the requirements of the visit plan; * Patients who may be absent from the visit period for 2 weeks or more during the treatment period; * The researchers determine that the subjects have other factors that could have caused the study to be discontinued.
References
Publications (0)
Data not yet available