Using ctDNA to guide capecitabine maintenance after pancreatic cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, large-scale observational study will follow adults who had R0 resection for pancreatic ductal adenocarcinoma and received standard adjuvant therapy including gemcitabine plus capecitabine. Participants will undergo serial ctDNA-MRD blood testing after surgery and during follow-up to guide selection of postoperative capecitabine monotherapy maintenance and to monitor for molecular recurrence. The study will collect safety and efficacy outcomes, including recurrence-free and overall survival, and correlate them with ctDNA status. All procedures, including clinic visits and blood draws, are conducted at the sponsoring hospital without investigational drugs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Juan Du, professor
• Email: dujuanglyy@163.com
• Phone: +8613951826526

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Using contrast-enhanced ultrasound to check for local pancreatic cancer recurrence after surgery

  This pilot test uses contrast-enhanced ultrasound to see if it can help detect return of pancreatic cancer after surgery in patients being watched with CT scans.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07910383

• Combination of ivermectin with standard skin-protective care for daraxonrasib-related skin toxicity in pancreatic cancer

  This study tests whether adding ivermectin to standard preventive skin care helps people with pancreatic cancer who develop skin side effects from daraxonrasib.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895498

• Becotatug Vedotin Plus Anti-PD-1 and S-1 in EGFR-Positive Advanced Pancreatic Cancer

  This study tests a three-drug regimen (becotatug vedotin, an anti-PD-1 therapy, and S-1) in adults with EGFR-positive advanced pancreatic cancer who have not responded to at least one prior therapy.

  Recruiting Ningbo Medical Center Lihuili Hospital · Ningbo, Zhejiang · NCT07892573

• Blood protein biomarkers to help diagnose pancreatic cancer in adults

  This study tests whether blood protein biomarkers can help detect pancreatic ductal adenocarcinoma and tell it apart from chronic pancreatitis and mucinous pancreatic lesions, and whether combining markers with CA 19-9 improves accuracy.

  Recruiting Grigore T. Popa University of Medicine and Pharmacy · Iași · NCT07875582

• Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Cancer (Phase 1)

  This early-stage study tests whether giving Lm-LLO-TT directly into the belly with low-dose gemcitabine is safe and tolerable for adults with previously treated, unresectable or metastatic pancreatic cancer.

  Recruiting Phase 1 Matter Bio, Inc. · The Bronx, New York · NCT07828236

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.