To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
This is a multicenter, randomized, open-label, active-controlled, phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
502
Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Camrelizumab: 200mg, IV drip, Q3W, D1 3. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 4. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 3. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause
Time frame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months)
Progression-free Survival (PFS) (RECIST1.1)
A duration from the date of initial treatment to disease progression or death of any cause.
Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
Objective response rate (ORR)(RECIST1.1)
The incidence of confirmed complete response or partial response
Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
Duration of response (DoR)(RECIST1.1)
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
Disease control rate (DCR)(RECIST1.1)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months)
Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)(only for phase III)
The changes in health-related quality of life (HRQoL) score from baseline and the time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \- Core 30 (EORTC QLQ-C30)
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Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing General Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITING...and 42 more locations
Time frame: From the within 7 days prior to the initiation of treatment to 30 days after the last administration
Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)(only for phase III)
The changes in health-related quality of life (HRQoL) score from baseline and thehe time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \- PAN26 (EORTC QLQ-PAN26)
Time frame: From the within 7 days prior to the initiation of treatment to 30 days after the last administration