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Clinical Trial Record

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Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer

2021-03-25

2026-04

2026-12

934

Study Overview

Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer

This study aims to further observe and evaluate whether the three-week administration of albumin-bound paclitaxel combined with gemcitabine is equivalent to the four-week administration in the treatment of inoperable locally advanced or metastatic pancreatic cancer

Pancreatic cancer is a common clinical malignant tumor of the digestive system, and its incidence is gradually increasing worldwide.The prognosis is poor and the mortality rate is high, accounting for about 7% of cancer deaths.Albumin-bound paclitaxel is a good first-line treatment for pancreatic cancer. It has the advantages of high dose, high tumor tissue distribution, high efficacy, and low toxicity.It is hoped that the low-dose intensity can achieve the same clinical efficacy as the high-dose intensity, which provides strong evidence for the clinical choice of low-dose intensity.

  • Pancreatic Cancer
  • DRUG: albumin-bound paclitaxel
  • TJGI-003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-08-16  

N/A  

2021-09-14  

2021-08-31  

N/A  

2021-09-21  

2021-09-05  

N/A  

2021-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Low dose strength: albumin-bound paclitaxel + gemcitabine

albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8 q3w

DRUG: albumin-bound paclitaxel

  • Experimental:Albumin-bound paclitaxel combined with gemcitabine was administered on the first and eighth day, a cycle of three weeks Active Comparator: Albumin-bound paclitaxel combined with gemcitabine was administered on the first, eighth, and fifteenth
ACTIVE_COMPARATOR: High dose strength: albumin-bound paclitaxel + gemcitabine

albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8,15 q4w

DRUG: albumin-bound paclitaxel

  • Experimental:Albumin-bound paclitaxel combined with gemcitabine was administered on the first and eighth day, a cycle of three weeks Active Comparator: Albumin-bound paclitaxel combined with gemcitabine was administered on the first, eighth, and fifteenth
Primary Outcome MeasuresMeasure DescriptionTime Frame
Progression-free Survival (PFS)From date of randomization until the date of first documented progression or date of death from any causethrough study completion, an average of 5year
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease Control Rate(DCR)The percentage of confirmed complete remission, partial remission and stable disease among patients with evaluable efficacythrough study completion, an average of 5year
Objective response rate(ORR)The proportion of patients whose tumors have shrunk to a certain level and maintained for a certain period of time, including CR and PR cases.The solid tumor response assessment standard (RECIST 1.1 standard) was used to assess the objective tumor response.The subject must have measurable tumor lesions at baseline.According to the RECIST 1.1 standard, the efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable (SD), and progress (PD)through study completion, an average of 5year
Overall survival(OS)From date of randomization until the date of death from any causethrough study completion, an average of 5year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Liu rui, professor

Phone Number: 13602139003

Email: Liurui9003@163.com

Study Contact Backup

Name: Ji zhi, professor

Phone Number: 18526643284

Email: jizhikey@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Age: ≥18 years old, no gender limit; 2. Inoperable locally advanced or metastatic pancreatic cancer patients (except islet cell carcinoma) diagnosed by pathology or histology; 3. The patient has not undergone standard systemic treatment in the past, or more than half a year after the end of postoperative treatment.For those who have undergone major surgery or radiotherapy, the interval must be more than 4 weeks and their metastases have not received any local treatment including radiotherapy, chemotherapy, surgical treatment, etc.; 4. At least one measurable lesion (CT scan of tumor lesions with long diameter ≥ 10 mm, CT scan of lymph node lesions with short diameter ≥ 15 mm, and scan thickness not greater than 6 mm); 5. The main organs are functioning normally, that is, they meet the following standards:Routine blood examination: Hb≥90g/L (no blood transfusion within 14 days);ANC ≥1.5×109/L;PLT ≥100×109/L;Biochemical examination: ALB≥29 g/L (without ALB in 14 days), TBIL <1.5 times the upper limit of normal (ULN);ALT and AST≤3ULN, accompanied by liver metastasis, then ALT and AST<5×ULN;Cr ≤1.5×ULN or creatinine clearance rate ≥60ml/min; 6. The subject voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up
    Exclusion Criteria:
    1. Pregnant or lactating women; 2. Patients suffering from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. Those who have been confirmed to be allergic to the test drug albumin-bound paclitaxel and gemcitabine or its excipients. 4. The patient has clinically significant ascites; 5. Those who have experienced arterial/venous thrombosis within six months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 6. Patients with active hepatitis B or C; 7. Doctors think it is not suitable for inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_DIRECTOR: Ji zhi, professor, Tianjin Medical University Cancer Institute and Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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