Evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of patients with biliary tract malignancies.
Existing immune-combination chemotherapy has shown excellent data in advanced biliary malignancies, so what is the efficacy and safety of this regimen in neoadjuvant therapy? Moreover, the current combination model of immunization combined with anti-angiogenic drugs has become another new direction in the field of solid tumor treatment. Therefore, our group designed a single-arm, prospective clinical study of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of biliary malignancies, aiming at evaluating the efficacy and safety of adebrelimab in combination with apatinib, gemcitabine and cisplatin in the neoadjuvant treatment of biliary malignancies in patients with a view to bringing longer-term benefits to patients with resectable biliary malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Adebrelimab: 1200mg or 20mg/kg, iv, D1, Q3W;
Apatinib: 250 mg, po, QD, Q3W;
Gemcitabine: 1000 mg/m2, iv, 30min, D1, D8, Q3W;
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGRelapse free survival(RFS)
Means the time from the date of the curative surgery to the date of relapse or death.
Time frame: 3 years
AE
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: 3 years
Pathological complete response rate (pCR)
Rate of residual tumor cells not detected by pathology in excised tissue samples.
Time frame: Within one week after surgery
Major pathological response rate (MPR)
The percentage of active tumor cells in excised tissue samples is less than 10% of the rate.
Time frame: Within one week after surgery
surgery rate
Proportion of patients with final surgical resection among enrolled surgically resectable patients.
Time frame: Within one week after surgery
Radical (R0) resection rate
No residual cancer cells on the margins
Time frame: Within one week after surgery
Objective response rate (ORR)
Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR) or partial remission (PR) as rated according to RECIST 1.1 criteria. If efficacy of CR or PR is achieved, subjects must be confirmed not less than 4 weeks ± 7 days after the initial evaluation.
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Cisplatin: 25 mg/m2, iv, 30min, D1, D8, Q3W; Injection sequence: adebelizumab → gemcitabine → cisplatin (sequential interval of at least 30 min), 3 cycles of neoadjuvant therapy.
Time frame: Within 2 weeks prior to surgery
Disease control rate (DCR)
Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR), partial remission (PR), and stable disease (SD) as rated according to RECIST 1.1 criteria.
Time frame: Within 2 weeks prior to surgery
Overall survival (OS)
Defined as the time between the date of first dose and the death of the subject due to all causes. Subjects who were alive at the last follow-up visit had OS counted as data censored at the time of the last follow-up visit. The OS of subjects who were lost to follow-up was counted as data censored at the time of last confirmed survival prior to the lost follow-up. OS for data censoring was defined as the time from first dose to censoring.
Time frame: 5 years