This study is designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS (nab-paclitaxel and S-1) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in unresectable advanced or metastatic pancreatic cancer.
For patients with advanced pancreatic cancer (APC), chemotherapy is still the predominant treatment. The first-line regimens include AG (nab-paclitaxel and gemcitabine) and FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). AS (nab-paclitaxel and S-1) was explored and widely used in China especially for those with poor performance. This prospective, randomized controlled phase 1b/2 clinical study was designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS as first-line treatment compared with AG in APC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
phase 1b: surufatinib 200 or 250 mg/d, qd po; camrelizumab: 200mg, I.V., D1, Q3W; nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; S-1: 40mg bid, D1-14, Q3W; DLTs will be evaluated at first cycle; phase 2: surufatinib RP2D + camrelizumab + nab-paclitaxel + S-1 when evaluated SD, PR or CR after 4-6 cycles (according to RECIST 1.1), followed by maintenance treatment: surufatinib + camrelizumab + S-1
nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W
Chinese PLA General Hospital
Beijing, China
RECRUITINGDLTs
Dose-limiting toxicities will be evaluated by the investigators at the first cycle in Ib phase
Time frame: Up to 21 days after the first dose of surufatinib
RP2D
The RP2D is defined as the dose level of surufatinib chosen by the investigators for the phase II experimental arm, based on DLTs
Time frame: Up to 21 days after the first dose of surufatinib
ORR
The proportion of patients with a confirmed complete response or partial response
Time frame: up to 3 years
PFS
PFS is defined as the time (in days) from randomization to disease progression or death.
Time frame: up to 3 years
DCR
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)
Time frame: up to 3 years
OS
OS is defined as the time from randomization to death from any cause.
Time frame: up to 3 years
DOR
DOR is defined as the time from the first documented CR or PR to disease progression or death.
Time frame: up to 3 years
TTR
TTR is defined as the time from randomization to achieving the first objective response.
Time frame: up to 3 years
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Safety and tolerability by incidence, severity and outcome of adverse events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Time frame: up to 3 years