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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2026
  • participants needed
    934
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 1 October 2021
ct scan
paclitaxel
measurable disease
carcinoma
metastasis
liver metastasis
gemcitabine
cancer chemotherapy
metastatic pancreatic cancer

Summary

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

Description

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.

Details
Condition Islet Ce417ll Cancer, pancreatic cancers, Digestive System Neoplasms, Neoplasm of unspecified nature of digestive system, Pancreatic disorder, cancer, pancreatic, cancer of the pancreas, Pancreatic Disorders, Pancreatic Cancer
Treatment albumin-bound paclitaxel, albumin-bound paclitaxel + gemcitabine
Clinical Study IdentifierNCT05035147
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on1 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 18 years old, no gender limit
Inoperable locally advanced or metastatic pancreatic cancer patients (except islet cell carcinoma) diagnosed by pathology or histology
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
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)
The main organs are functioning normally, that is, they meet the following standards:Routine blood examination: Hb90g/L (no blood transfusion within 14 days);ANC 1.5109/L;PLT 100109/L;Biochemical examination: ALB29 g/L (without ALB in 14 days), TBIL <1.5 times the upper limit of normal (ULN);ALT and AST3ULN, accompanied by liver metastasis, then ALT and AST<5ULN;Cr 1.5ULN or creatinine clearance rate 60ml/min
The subject voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up

Exclusion Criteria

Pregnant or lactating women
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
Those who have been confirmed to be allergic to the test drug albumin-bound paclitaxel and gemcitabine or its excipients
The patient has clinically significant ascites
Those who have experienced arterial/venous thrombosis within six months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism
Patients with active hepatitis B or C
Doctors think it is not suitable for inclusion
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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