Clinical trial · Interventional
Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy.
A Phase III, Multicenter, Prospective, Randomized, Patients With Resectable Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nab-paclitaxel and Gemcitabine
- description
- Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15;Gemcitabine 1000 mg/m2 was given intravenously for more than 30min on days 1, 8, and 15, and repeated every 4 weeks.
- interventionNames
- Drug: Nab paclitaxel
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- mFOLFIRINOX
- description
- Oxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks.
- interventionNames
- Drug: mFOLFIRINOX
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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