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

Non-inferiority Study of Albumin-bound Paclitaxel Combined With Gemcitabine for Three Weeks Versus Four Weeks for First-line Inoperable Locally Advanced or Metastatic Pancreatic Cancer

This study is testing if giving a combination of two cancer drugs, albumin-bound paclitaxel and gemcitabine, every three weeks can help people with inoperable pancreatic cancer just as well as giving them every four weeks.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 934 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT05035147 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with inoperable locally advanced or metastatic pancreatic cancer who have not received prior systemic treatment.

Not a fit: Patients with islet cell carcinoma or those who have received recent systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and less toxic treatment option for patients with inoperable pancreatic cancer.

How similar studies have performed: Previous studies have shown promise with albumin-bound paclitaxel in treating pancreatic cancer, but this specific combination and dosing schedule is being evaluated for the first time.

Eligibility criteria

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 this trial is running

Tianjin, Tianjin Municipality

• Rui Liu — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Liu rui, professor

Conditions Pancreatic Cancer