Status:
UNKNOWN
Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy.
Lead Sponsor:
Fudan University
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 observ...
Detailed Description
This study is a prospective, multicenter, randomized, controlled Ⅲ period clinical trials.A total of 600 patients with resectable pancreatic cancer assessed by imaging and serum CA125≥35 U/mL were ran...
Eligibility Criteria
Inclusion
- Voluntarily participate and sign the informed consent;
- Age ≥18 years old and ≤75 years old, no gender limitation;
- ECOG score ≤1;
- Imaging evaluation of resectable pancreatic cancer, serum CA125≥35 U/mL;
- pancreatic adenocarcinoma confirmed by pathology after pancreatic puncture or surgery;
- No distant metastasis, malignant abdominal effusion or pleural effusion before neoadjuvant chemotherapy;Postoperative baseline chest, abdomen and pelvis CT showed no tumor metastasis/recurrence.
- Expected survival ≥3 months;
- 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;
- the willingness of women with potential fertility to use medically approved contraceptives in the trial;
- Able to follow the research visit plan and other program requirements.
Exclusion
- Patients had received any type of anti-tumor therapy before enrolment, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;
- have central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other uncontrollable serious diseases;
- 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;
- Have a history of other malignant tumor diseases;
- Have a history of allergy to the study drug or similar drug structure;
- Pregnant and lactating women;
- Other reasons why the investigator considers it inappropriate to participate in the clinical study.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04835064
Start Date
April 1 2021
End Date
December 1 2024
Last Update
April 8 2021
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