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A Single-Center Phase II Study to Evaluate the Efficacy of Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer Based on Circulating Tumor DNA Detection

A Single-Center Phase II Study to Evaluate the Efficacy of Adjuvant Chemotherapy After Radical Resection of Pancreatic Cancer Based on Circulating Tumor DNA Detection

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033479
Enrollment
Unknown
Registered
2020-06-02
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Interventions

GEM group:Gemcitabine 1000mg/m2, intravenous infusion, once a week, after three consecutive weeks stop for a week, for a cycle, a total of 6 cycles
AG group:Albumin paclitaxel 125mg / m2 + gemcitabine 1000mg / m2, intravenous infusion, once a week, stopping for three weeks after a week, for a period of 6 cycles

Sponsors

East China Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who voluntarily participate in and sign informed consent; 2. Patients aged >= 18 years and <= 80 years, regardless of gender; 3. Patients who did not receive any chemotherapy 4-12 weeks after operation; 4. Patients with pancreatic ductal adenocarcinoma confirmed by postoperative pathology; 5. Pathological stage: t1-3, n0-1, M0; 6. Patients with R0 or R1 resection; 7. ECoG physical condition score: 0-1.

Exclusion criteria

Exclusion criteria: 1. Patients with metastasis or recurrence were found by CT examination before chemotherapy; 2. Patients with other systemic malignancies; 3. Patients with other systemic diseases that are not suitable for chemotherapy; 4. Patients with any condition that may damage the safety of patients or the integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities.

Design outcomes

Primary

MeasureTime frame
Disease-free Survival;the mutation of ctDNA KRAS;

Secondary

MeasureTime frame
Overall Survival;

Countries

China

Contacts

Public ContactJiang Chongyi

East China Hospital Affiliated to Fudan University

jiangzhongyi9@126.com+86 18101802916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026