Abstract 136P
Background
Advanced biliary tract cancer (BTC) has a poor prognosis, with a 5-year survival rate of less than 5%.Chemotherapy combined with tyrosine kinase inhibitors and immune checkpoint inhibitors as the first-line treatment has shown good safety in the phase I study. The purpose of this phase II study was to further evaluate the efficacy and safety of gemcitabine and oxaliplatin (Gemox) plus tislelizumab and donafenib.
Methods
This is a prospective single-center exploratory study. Patients were enrolled if they were aged 18-75 years (inclusive) with histologically or cytologically documented stage III/IV (AJCC Cancer Staging Manual, 8th Edition) BTC, at least one measurable disease per RECIST v1.1, ECOG PS 0-1 and Child-Pugh A/B. Patients received gemcitabine 1000 mg/m2 IV Q3W, oxaliplatin 100 mg/m2 lV Q3W, donafenib 200 mg PO BlD and tislelizumab 200 mg IV Q3W until disease progression, unacceptable toxicity or withdrawal of consent, whichever occurred first. The primary endpoint was the objective response rate (ORR).
Results
From December 2022 to April 2024,23 patients were enrolled (17 males and 6 females; 4 stage Ⅲ and 19 stage Ⅳ; ECOG PS 1; median age 58 years; 4 gallbladder cancer, 1 hilar cholangiocarcinoma and 18 intrahepatic cholangiocarcinoma).At data cut-off (April 15 2024), the median follow-up time was 10.3 months(95%CI,9.6-11.0).The ORR was 39.1%, with a partial response (PR) rate of 39.1%.The disease control rate (DCR) was 95.7%. Treatment-related adverse events (TRAEs) occurred in all patients (100%), including 12 (52.2%) patient had grade 3-4 TRAEs. No grade 5 TRAEs were observed. The most common grade 3-4 TRAEs were rash (6/23, 26.1%), fever (3/23, 13.0%) and Joint pain(2/23,8.7%). One stage Ⅲ patient underwent subsequent surgery.
Conclusions
GEMOX plus tislelizumab and donafenib as a 1L treatment option for advanced BTC patients shows favorable efficacy and tolerability. This therapy may also provide an opportunity for curative resection.
Clinical trial identification
NCT05668884.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.