Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer
NCT06361030 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-04-11
Summary
To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer
Conditions
- Pancreatic Cancer
- Pancreatic Cancer Non-resectable
- Pancreatic Ductal Adenocarcinoma, PDAC
Interventions
- DRUG
-
surufatinib combined with gemcitabine plus nab-paclitaxel
Surufatinib capsules: oral, once daily. Combination treatment period: 200 mg each time, every 4 weeks for a treatment cycle(Q4W). If all the chemotherapy drugs were stopped during the maintenance treatment period, only surufatinib was left, the dose of Surufatinib could be increased to 300 mg per dose according to the patient\'s condition. Gemcitabine: iv, 1000 mg/m2, days 1, 8, and 15 of each treatment cycle, Q4W. Paclitaxel (albumin-bound), iv, 125mg/m2, on days 1, 8 and 15 of each treatment cycle, Q4W. All they will be used until disease progression, death, intolerable toxicity, initiation of new antineoplastic therapy, withdrawal of consent, loss to follow-up, or any other protocol-specified event requiring treatment discontinuation or study closure, whichever occurred first. But If surgical resection was performed, they will be only maintained for 6 months after surgery.
Sponsors & Collaborators
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Heshui Wu · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2026-06-01
- Completion
- 2027-06-01
Countries
- China
Study Locations
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