Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer
Recruiting · NCT05035147 · Interventional (participants receive a specific treatment) · Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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: 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;
- 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.
Where it is running
1 location listed.
- Rui Liu - Tianjin, Tianjin Municipality, China