A Real-world Study of Albumin-bound Paclitaxel in the Treatment of Pancreatic Cancer

NCT ID: NCT03768687

Last Updated: 2018-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-20

Study Completion Date

2020-06-01

Brief Summary

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Pancreatic cancer progresses rapidly and has a higher death rate. Albumin-bound paclitaxel is a new generation of paclitaxel . Albumin-bound paclitaxel is recommended as a class 1A evidence treating patients with pancreatic cancer.The purpose of this study was to further observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel in the treatment of non-operative locally advanced or metastatic pancreatic cancer and to explore the prognostic factors .

Detailed Description

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This is a prospective, single-arm, observational study. After the subjects meet the inclusive and exclusive criteria, then they will receive albumin-bound paclitaxel treatment. The researchers can choose the treatment based on albumin-bound paclitaxel and choose dosage according to the patient's condition.

Conditions

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Pancreatic Cancer

Keywords

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pancreatic cancer albumin-bound paclitaxel

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age: 18 -80, male or female;
2. Non-operative patients with locally advanced or metastatic pancreatic cancer diagnosed by pathology or histology (except islet cell carcinoma);
3. The patient has not received standard systematic treatment in the past, and the metastatic site has not received any local treatment, including radiotherapy, chemotherapy, surgical treatment, etc.;
4. At least one measurable lesion (CT scan length of tumor lesion is greater than 10 mm, CT scan short diameter of lymph node lesion is greater than 15 mm, scanning layer thickness is not greater than 5 mm);
5. The subjects volunteered to participate in this study and signed the informed consent form, with good compliance to follow-up.

Exclusion Criteria

1. Pregnant or lactating women;
2. Patients allergy to albumin-bound paclitaxel or its excipients
3. Patients with albumin-bound paclitaxel contraindication;
4. Doctors consider those who are not suitable for this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Baorui Liu

chief doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baorui Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Nanjing University Medical School

Locations

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The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Baorui Liu, Doctor

Role: CONTACT

Phone: 13770621908

Email: [email protected]

Juan Du, Doctor

Role: CONTACT

Phone: 13951826526

Email: [email protected]

Facility Contacts

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Baorui Liu, Doctor

Role: primary

Juan Du, Doctor

Role: backup

References

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Dai W, Qiu X, Lu C, Zou Z, Sha H, Kong W, Liu B, Du J. AGIG Chemo-Immunotherapy in Patients With Advanced Pancreatic Cancer: A Single-Arm, Single-Center, Phase 2 Study. Front Oncol. 2021 Oct 13;11:693386. doi: 10.3389/fonc.2021.693386. eCollection 2021.

Reference Type DERIVED
PMID: 34722242 (View on PubMed)

Other Identifiers

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EXPLORE-PC101

Identifier Type: -

Identifier Source: org_study_id