Combining albumin-bound paclitaxel with gemcitabine for treating inoperable pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of administering albumin-bound paclitaxel combined with gemcitabine every three weeks compared to a four-week regimen for patients with inoperable locally advanced or metastatic pancreatic cancer. The aim is to determine if a lower dose intensity can achieve similar clinical outcomes as a higher dose, potentially leading to improved treatment options. The trial focuses on patients who have not received prior systemic treatment or have had a significant interval since their last treatment. The study will measure the efficacy based on tumor response and patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rui Liu
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Liu rui, professor
• Email: Liurui9003@163.com
• Phone: 13602139003

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.