Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy.

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of

• To observe the overall survival of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy A secondary purpose

• To observe relapse-free survival in patients with resectable pancreatic cancer with elevated serum CA125 versus without neoadjuvant chemotherapy

• To observe the resectable rate of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy

• To observe the safety parameters of patients with resectable pancreatic cancer with or without neoadjuvant chemotherapy with elevated serum CA125

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Folfirinox; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Voluntarily participate and sign the informed consent;

2. Age ≥18 years old and ≤75 years old, no gender limitation;

3. ECOG score ≤1;

4. Imaging evaluation of resectable pancreatic cancer, serum CA125≥35 U/mL;

5. pancreatic adenocarcinoma confirmed by pathology after pancreatic puncture or surgery;

6. No distant metastasis, malignant abdominal effusion or pleural effusion before neoadjuvant chemotherapy;Postoperative baseline chest, abdomen and pelvis CT showed no tumor metastasis/recurrence.

7. Expected survival ≥3 months;

8. No serious hematopoietic dysfunction, abnormal functions of heart, lung, liver and kidney and immune deficiency were observed. The laboratory test results met the following criteria: blood routine indicators: white blood cell (WBC) ≥3×109/L;Absolute neutrophils count (ANC) ≥1.5×109/L;Platelet (PLT) ≥100×109/L;Hemoglobin (HGB) ≥9g/dL;Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤2.5× upper limit of normal value (ULN);Total bilirubin (TBil) ≤ULN;Serum creatinine (CRE) ≤1.5×ULN;Coagulation function: Prothrombin time (PT), international standardized ratio (INR) ≤1.5×ULN;

9. the willingness of women with potential fertility to use medically approved contraceptives in the trial;

10. Able to follow the research visit plan and other program requirements.

Exclusion Criteria:

1. Patients had received any type of anti-tumor therapy before enrolment, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;

2. have central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other uncontrollable serious diseases;

3. Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications at baseline;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) cannot be corrected;

4. Have a history of other malignant tumor diseases;

5. Have a history of allergy to the study drug or similar drug structure;

6. Pregnant and lactating women;

7. Other reasons why the investigator considers it inappropriate to participate in the clinical study.