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

NCT04835064 | Unknown Phase 3

• 1 other identifier: CSPAC-4
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• overall survival

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

  from randomization to death, up to 36 months

Secondary Outcomes (3)

• Relapse-free survival

  from randomization to recurrence, up to 36 months

• Surgical excision rate

  from randomization to recurrence, up to 36 months

• Incidence of adverse events

  from randomization to recurrence, up to 36 months

Study Arms (2)

Nab-paclitaxel and Gemcitabine

EXPERIMENTAL

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.

Drug: Nab paclitaxel; Drug: Gemcitabine

mFOLFIRINOX

EXPERIMENTAL

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.

Drug: mFOLFIRINOX

Interventions

Nab paclitaxel DRUG

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

Also known as: Abraxane

Nab-paclitaxel and Gemcitabine

Gemcitabine DRUG

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

Also known as: Gemzar

Nab-paclitaxel and Gemcitabine

mFOLFIRINOX 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.

Also known as: modified FOLFIRINOX regimen

mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Interventions

Taxes; Albumin-Bound Paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xian-Jun Jun, M.D., Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

86 21 64175590; xiahuanyu@fudanpci.org

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

CONTACT

+86 21 64175590; wangwenquan@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Shanghai Pancreatic Cancer Institute

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share