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

NCT04835064 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2021-04-08

No results posted yet for this study

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

Interventions

DRUG

Nab paclitaxel

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

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

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xian-Jun Jun, M.D., Ph.D. · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2024-04-01
Completion
2024-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04835064 on ClinicalTrials.gov