The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer (MAP-02)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Resectable Carcinoma; Pancreatic Cancer

Treatments: Drug: Later-line therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05802407

K3378-02

Details and patient eligibility

About

The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in resected pancreatic cancer. The main questions it aims to answer are:

• prognostic value of baseline MRD;
• the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before adjuvant chemotherapy initiation and at the first imaging assessment after chemotherapy.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with pancreatic cancer who had undergone curative-intent surgery (R0 or R1 resection);
• both sexes, age ≥18 years old;
• ECOG performance status score ≤2;
• the expected survival time was ≥3 months.

Exclusion criteria

• a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;
• treated with any systemic antitumor treatment before first-line chemotherapy onset;
• died or lost to follow-up within one month after the initiation of adjuvant chemotherpay;
• combined with other primary malignances.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

MRD-guided

Experimental group

Description:

Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.

Treatment:

Drug: Later-line therapy

Routine treatment

No Intervention group

Description:

Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy.