To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer
The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up;
Aged 18-75 years old (including 18 and 75 years old)
male or female
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Participants had a second primary malignancy detected prior to the first dose of study treatment, or has other malignancies diagnosed within 5 years prior to the first dose of study treatment, with the exception of radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ;
Allergy to study medication or excipients
With dysphagia or known malabsorption of drugs
Have participated in any other drug clinical trial and received the corresponding trial drug within the previous 4 weeks. Or are participating in other clinical studies that may interfere with this study.
Single group
surufatinib combined with gemcitabine plus nab-paclitaxel
DrugSurufatinib 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.
Surgical conversion rate
Surgical conversion rate, defined as the proportion of patients who achieved gross complete resection after 4-6 cycles of study induction therapy.
Objective Response Rate (ORR)
Objective response rate (ORR) was defined as complete response (CR) and partial response (PR) proportion of participants.
Disease control rate (DCR)
Disease control rate (DCR) was defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD).
R0 surgical conversion rate
R0 surgical conversion rate: defined as the proportion of patients who achieved R0 surgical resection after 4-6 cycles of study induction therapy.
progression free survival(PFS)
Progression-free survival (PFS), defined as the time from the first initiation of study regimen treatment to the first imaging disease progression or the time of death, whichever occurs first.
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