MRD in PAAD Adjuvant Therapy

N/AActive Not RecruitingNCT06867146

Peking Union Medical College Hospital60 enrolled

Overview

Our preliminary research has explored the detection efficacy of minimal residual disease (MRD) in pancreatic cancer. In patients with pancreatic cancer undergoing dual-agent adjuvant chemotherapy, the median recurrence-free survival (RFS) is approximately 13.9 months. Due to the high postoperative recurrence rate, short survival time, and intense systemic chemotherapy in pancreatic cancer patients, there is an urgent clinical need to more accurately identify which patients will benefit from adjuvant therapy. This study aims to evaluate the application value and guiding significance of peripheral blood MRD in the decision-making process for adjuvant treatment in patients with resected pancreatic cancer.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy Molecular Residual Disease

Interventions

Three-drug chemotherapy groupDRUG

Three-drug chemotherapy group, mFOLFIRINOX, including 5-fluorouracil, leucovorin, oxaliplatin and irinotecan.

two-drug chemotherapy groupDRUG

two-drug chemotherapy group, including gemcitabine-based combination regimens (predominately gemcitabine/nab-paclitaxel or gemcitabine/capecitabine)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Here's the translated and polished version of your content: 1. Patients clinically diagnosed with pancreatic cancer, staged I-III (AJCC V8.0), who are scheduled to undergo curative surgery. 2. No restrictions on gender; age between 18 and 70 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status score: ≤2. 4. Expected survival time of ≥3 months. 5. Willingness to comply with the study protocol for testing, treatment, and follow-up; consent to provide necessary clinical, pathological, and follow-up data for the study; and agreement to use the research data for future studies and product development. 6. Voluntary participation in this clinical study, with an understanding of the study procedures and the ability to sign an informed consent form. Exclusion Criteria: 1. Patients who have had other malignancies within the five years prior to this study. 2. Patients who have received any antitumor treatment within six months prior to enrollment. 3. Patients with concomitant diseases that, in the investigator's judgment, pose a serious risk to patient safety or could affect the patient's ability to complete the study (such as poorly controlled hypertension, severe diabetes, thyroid disorders, psychiatric disorders, etc.), or any other conditions deemed unsuitable for participation.

Outcomes

Primary Outcomes

DFS

DFS refers to the length of time after treatment during which a patient remains free of any signs or symptoms of the disease. It is primarily used in cancer research to measure the effectiveness of treatments in preventing recurrence. Median follow-up time up to 18 months

Time frame: up to 18 months

Secondary Outcomes

OS measures the length of time from either the diagnosis or the start of treatment to the death of the patient, regardless of cause. Median follow-up time up to 18 months.