CtDNA-guided Maintenance Therapy in Pancreatic Cancer

NCT07054879 | Recruiting

• 1 other identifier: PC-Maintenance therapy
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to conduct a large-scale prospective clinical trial to evaluate the efficacy and safety of capecitabine monotherapy as maintenance treatment following standard adjuvant chemotherapy (gemcitabine plus capecitabine) in patients with resectable pancreatic cancer, and to analyze whether ctDNA-MRD testing can guide the selection of postoperative maintenance therapy.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; maintenance therapy; ctDNA; capecitabine maintenance therapy

Outcome Measures

Primary Outcomes (1)

• 2-year DFS rate

  the proportion of cancer patients who remain free of disease recurrence or death from any cause within 2 years after surgery

  At the timepoint of 2 years after surgery

Study Arms (1)

Experiment Group

Patients received 6 cycles of standard adjuvant chemotherapy (gemcitabine plus capecitabine), followed by capecitabine monotherapy as maintenance treatment based on the patient's clinical condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pancreatic caner patients with R0 surgery

You may qualify if:

• Age ≥18 years, male or female
• Histologically or cytologically confirmed primary diagnosis of pancreatic ductal adenocarcinoma (PDAC)
• No evidence of distant metastasis (M0)
• Underwent R0 radical resection within 3 months prior to enrollment
• ECOG performance status of 0-1
• Life expectancy ≥3 months
• Patient or legal guardian is able to understand the study requirements and willing to provide written informed consent

You may not qualify if:

• Prior history of radiotherapy, chemotherapy or surgical treatment for pancreatic cancer
• Concurrent severe organ dysfunction or hematologic disorders
• Tumor involvement of celiac axis or superior mesenteric artery, locally advanced disease, or presence of distant metastases
• Poor general condition deemed unable to tolerate chemotherapy
• History of other malignancies within past 5 years (except adequately treated carcinoma in situ of cervix or basal cell carcinoma of skin)
• Any severe or uncontrolled systemic disease that may affect risk/benefit assessment, including but not limited to: uncontrolled hypertension, active hepatitis B or C infection, HIV infection
• Patient or guardian unable to comprehend study objectives and requirements
• Any other condition that in the investigator's judgment would make the patient unsuitable for study participation

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor sample and plasma sample

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Juan Du, professor

CONTACT

+8613951826526; dujuanglyy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

CN (1)