This phase II trial studies how well gemcitabine, cisplatin and durvalumab/Pembrolizumab and surufatinib work in treating participants with advanced Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Whether if adding surufatinib to a standard of care can bring addition benefit needs to be explored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
200mg,qd,po
1000mg/ m2, IV,d1,8,q3w
25mg/m2,IV,d1,8,q3w
1500mg,IV,d1,q3w
200mg,IV,d1,q3w
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGORR
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
Time frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks and then every 8 weeks, through study completion, an average of 1 year
PFS
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of treatment until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Time frame: Tumor assessments every 6 weeks for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death,through study completion, an average of 1 year.
OS
Overall Survival (OS) was defined as the time from the date of treatment until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Time frame: through study completion, an average of 24 weeks
conversion rate
Number of patients amendable to curative surgical interventions defined as number of patients receiving curative surgical resection or transplantation after successful down-sizing of tumor(s) by intervention.
Time frame: through study completion, an average of 2 year
safety
Incidence, nature, and severity of adverse events graded according to the United States National Cancer Institute The Common Terminology Criteria for Adverse Events (NCI CTCAE 5.0)
Time frame: from the date of treatment to 90 days after last treatment
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