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

NCT ID: NCT04835064

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-12-01

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 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

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 randomly assigned according to the ratio of 1:1 (300 cases: 300 cases) between the direct surgical resection group and the neoadjuvant chemotherapy group, to observe the efficacy and safety of patients with resectable pancreatic cancer with elevated serum CA125 with or without neoadjuvant chemotherapy.Neoadjuvant chemotherapy and adjuvant chemotherapy can use albumin-binding paclitaxel combined with gemcitabine (AG) regimen or mFOLFirinox (5-FU, calcium leucofolate [LV], irinotecan, oxaliplatin) regimen. AG regimen was given on day 1, 8, 15, and repeated every 4 weeks.The mFOLFIRINOX regimen was administered on days 1 and 15 and repeated every 4 weeks.Patients in the neoadjuvant chemotherapy group were treated with 4 courses of neoadjuvant chemotherapy (AG regimen or mFOLFIRINOX regimen) immediately after the pathologic diagnosis of pancreatic adenocarcinoma was confirmed by puncture.Patients receiving neoadjuvant chemotherapy will undergo surgical exploration to assess the resectability of the tumor.Four to eight weeks after radical resection, the patients were treated with adjuvant chemotherapy from the recovery of surgical trauma. The choice of adjuvant chemotherapy after surgery depended on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy will maintain the original regimen;If neoadjuvant chemotherapy is ineffective but radical surgery is still feasible, adjuvant chemotherapy will be used with a crossover regimen.Neoadjuvant chemotherapy group received adjuvant chemotherapy for 2 courses.In the direct surgical resection group, 6 courses of adjuvant chemotherapy were started 4 to 8 weeks after radical resection.Relevant examinations should be conducted before and after each course of medication to evaluate safety events. Imaging reexaminations should be conducted every 2 courses of medication, and imaging reexaminations should be conducted every 3 months during follow-up to evaluate disease recurrence.

Conditions

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nab-paclitaxel and Gemcitabine

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.

Group Type: EXPERIMENTAL

Nab paclitaxel

Intervention Type: DRUG

Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15

Gemcitabine

Intervention Type: DRUG

Intravenous infusion of 1000 mg/m2 was given for more than 30min on days 1, 8, and 15, and repeated every 4 weeks

mFOLFIRINOX

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.

Group Type: EXPERIMENTAL

mFOLFIRINOX

Intervention Type: DRUG

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.

Interventions

Nab paclitaxel

Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15

Intervention Type: DRUG

Gemcitabine

Intravenous infusion of 1000 mg/m2 was given for more than 30min on days 1, 8, and 15, and repeated every 4 weeks

Intervention Type: DRUG

mFOLFIRINOX

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.

Intervention Type: DRUG

Other Intervention Names

Abraxane; Gemzar; modified FOLFIRINOX regimen

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

President of Shanghai Pancreatic Cancer Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xian-Jun Jun, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Xian-Jun Jun, M.D., Ph.D.

Role: CONTACT

xiahuanyu@fudanpci.org

86 21 64175590

Wen-Quan Wang, M.D., Ph.D.

Role: CONTACT

wangwenquan@fudanpci.org

+86 21 64175590

Other Identifiers

CSPAC-4

Identifier Type: -

Identifier Source: org_study_id