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Brief Title: Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer
Official Title: An Exploratory Clinical Study of Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Patients With Locally Advanced Pancreatic Cancer
Study ID: NCT06361030
Brief Summary: To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer
Detailed Description: Pancreatic ductal adenocarcinoma (PDAC) has a very poor prognosis. Currently, there is no standard treatment for locally unresectable PDAC, and clinical research and conversion therapy are encouraged by guidelines. Whether it is conversion or palliative chemotherapy, in fact, the choice of chemotherapy is based on the existing first-line regimens of metastatic PDCA. Gemcitabine combined with nab-paclitaxel is one of the preferred first-line chemotherapy regimens for metastatic or locally advanced PDAC. However, the conversion rate of gemcitabine combined with nab-paclitaxel is not ideal according to the current results. The aim of this study is to investigate whether the combination of gemcitabine and nab-paclitaxel with surufatinib can improve the surgical conversion rate. This is a prospective, single-arm exploratory clinical study. A safety run-in period of 6 patients will be set. After 4-6 cycles of induction therapy with gemcitabine and nab-paclitaxel plus surufatinib, if become operable, the therapy will be continued for another 6 months after surgery; if not operable, the therapy will be also continued as long as no PD during induction therapy. If PD occurs, it will enter second-line therapy. Surufatinib capsule will be administered orally 200mg, once daily, a 4-week treatment cycle(Q4W) during combined with gemcitabine and nab-paclitaxel. If all chemotherapy drugs are stopped during the maintenance treatment period and only surufatinib is left, the dose of surufatinib can be increased to 300 mg per dose according to the patient's condition. Gemcitabine and nab-paclitaxel plus surufatinib will be used until disease progression, death, intolerable toxicity, initiation of new antineoplastic therapy, withdrawal of informed consent, loss of follow-up, and other conditions that require treatment discontinuation or the study is completed. Whichever comes first. If surgical resection was performed, it will be maintained for 6 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Name: Heshui Wu
Affiliation: Wuhan Union Hospital, China
Role: PRINCIPAL_INVESTIGATOR