NCT05035147 Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer
| NCT ID | NCT05035147 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 934 participants |
| Start Date | 2021-03-25 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 934 participants in total. It began in 2021-03-25 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Ji zhi, professor
STUDY DIRECTOR
Tianjin Medical University Cancer Institute and Hospital
Frequently Asked Questions
Who can join the NCT05035147 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05035147 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05035147 currently recruiting?
Yes, NCT05035147 is actively recruiting participants. Contact the research team at Liurui9003@163.com for enrollment information.
Where is the NCT05035147 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05035147 clinical trial?
NCT05035147 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The principal investigator is Ji zhi, professor at Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 934 participants.
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