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

Last updated: September 14, 2021
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Pancreatic Disorders

Digestive System Neoplasms

Cancer

Treatment

N/A

Clinical Study ID

NCT05035147
TJGI-003
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: ≥18 years old, no gender limit;
  2. Inoperable locally advanced or metastatic pancreatic cancer patients (except isletcell carcinoma) diagnosed by pathology or histology;
  3. The patient has not undergone standard systemic treatment in the past, or more thanhalf a year after the end of postoperative treatment.For those who have undergonemajor surgery or radiotherapy, the interval must be more than 4 weeks and theirmetastases 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 notgreater than 6 mm);
  5. The main organs are functioning normally, that is, they meet the followingstandards:Routine blood examination: Hb≥90g/L (no blood transfusion within 14days);ANC ≥1.5×109/L;PLT ≥100×109/L;Biochemical examination: ALB≥29 g/L (without ALBin 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 creatinineclearance rate ≥60ml/min;
  6. The subject voluntarily joined the study and signed an informed consent form, withgood compliance and cooperation with follow-up

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Patients suffering from other malignant tumors in the past or at the same time, exceptfor 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 paclitaxeland gemcitabine or its excipients.
  4. The patient has clinically significant ascites;
  5. Those who have experienced arterial/venous thrombosis within six months, such ascerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosisand pulmonary embolism;
  6. Patients with active hepatitis B or C;
  7. Doctors think it is not suitable for inclusion.

Study Design

Total Participants: 934
Study Start date:
March 25, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Rui Liu

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

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