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A single-center prospective randomized controlled phase II trial comparing therapeutic efficacy in resectable pancreatic cancer patients with positive circulating tumor markers with or without neoadjuvant chemotherapy

A single-center prospective randomized controlled phase II trial comparing therapeutic efficacy in resectable pancreatic cancer patients with positive circulating tumor markers with or without neoadjuvant chemotherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052629
Enrollment
Unknown
Registered
2021-11-02
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

pancreatic cancer

Interventions

Experimental group:Neoadjuvant chemotherapy + surgery + adjuvant chemotherapy
Control group:Surgery + adjuvant chemotherapy

Sponsors

Huadong Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. If the following criteria are met at the same time, the subject will enter the research cohort Voluntarily participate and sign the informed consent; 2. Aged 18 to 75 years, gender is not limited; 3. ECOG score = 3 months; 8. No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency, laboratory test results meet the following standards: blood routine indicators: white blood cells (WBC) >= 3 x 10^9/L; neutrophils Absolute cell count (ANC) >= 1.5 x 10^9/L; Platelet (PLT) >= 100 x 10^9/L; Hemoglobin (Hgb) >= 9g/dL; Blood biochemical indexes: AST (SGOT), ALT (SGPT) <= 2.5 x Upper limit of normal (ULN); total bilirubin (TBIL) <= ULN; serum creatinine (CRE) <= 1.5 x ULN; coagulation function: prothrombin time (PT), international normalized ratio (INR)<= 1.5x ULN; 9. Women with potential fertility are willing to take medically approved contraceptive measures in the trial; Able to comply with study visit plans and other protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other uncontrollable serious diseases; 2. Uncontrolled infection, hemorrhage, pancreatic leakage, bile leakage, or other postoperative complications during the baseline examination; acute and chronic metabolic acidosis (including ketoacidosis, lactic acidosis) cannot be corrected; 3. Those with a history of other malignant tumors; 4. Have a history of allergy to the study drug or drugs of similar structure; 5. Pregnant and lactating women; 6. Patients have received any form of anti-tumor therapy before enrollment, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy; 7. Other reasons that the investigator considers unsuitable to participate in clinical research.

Design outcomes

Primary

MeasureTime frame
Disease free survival;

Secondary

MeasureTime frame
Overall survival;Radical resection rate;Safety parameters;

Countries

China

Contacts

Public ContactJiang Chongyi

Huadong Hospital, Fudan University

Jiangzhongyi9@126.com+86 18101802916

Outcome results

None listed

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