This is a phase II open-label, one-arm, multicenter study aimed to explore the efficacy and safety of perioperative (neoadjuvant and adjuvant) treatment for patients with advanced biliary tract carcinoma.
Enrolled participants should be treated with neoadjuvant camrelizumab and apatinib and GEMOX, after surgery, be treated with adjuvant camrelizumab and S-1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Perioperative treatment: camrelizumab plus apatinib in combination with GEMOX 2-4 cycles (neoadjuvant); camrelizumab plus S-1 up to 1 year (adjuvant).
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
1-year EFS rate
EFS was defined as the time from the first administration of study treatment to the first occurrence of any of the following events: disease progression that precluded surgical resection, disease recurrence after curative-intent surgery, disease progression in patients who did not undergo surgery, or death from any cause. 1-year EFS rate was the incidence rate of event-free survival within one year.
Time frame: 1 year
R0 resection rate
The proportion of patients who underwent complete tumor resection with microscopically negative margins
Time frame: up to 2 years
Major pathologic response (MPR)
10% or less residual viable tumor cells in the resected specimen
Time frame: up to 2 years
ORR
The proportion of patients with a confirmed complete or partial response
Time frame: up to 2 years
DCR
The proportion of patients with a complete response, partial response, or stable disease
Time frame: up to 2 years
EFS
EFS was defined as the time from the first administration of study treatment to the first occurrence of any of the following events: disease progression that precluded surgical resection, disease recurrence after curative-intent surgery, disease progression in patients who did not undergo surgery, or death from any cause.
Time frame: up to 5 years
OS
The time from the first dose of study treatment to death from any cause
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Time frame: up to 5 years
adverse event
Based on the assessment using CTCAE v5.0, the safety was evaluated.
Time frame: up to 2 years