Clinical trial · Interventional
Albumin-bound Paclitaxel Combined With Gemcitabine First-line 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
NCT05035147CI-TRIAL-00053983recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low dose strength: albumin-bound paclitaxel + gemcitabine
- description
- albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8 q3w
- interventionNames
- Drug: albumin-bound paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- High dose strength: albumin-bound paclitaxel + gemcitabine
- description
- albumin-bound paclitaxel 125mg/m2+ gemcitabine1000mg/m2:day1,8,15 q4w
- interventionNames
- Drug: albumin-bound paclitaxel
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.