In a Chinese phase II trial (ZSAB-TransGOLP) reported in The Lancet Oncology, Shi et al found promising results with tislelizumab plus lenvatinib and GEMOX (gemcitabine plus oxaliplatin) chemotherapy (GOLP) in converting unresectable locally advanced biliary tract cancer to resectable disease.
Study Details
In the trial, 41 eligible patients enrolled from two sites in China between December 2021 and July 2023 were treated with GOLP, consisting of tislelizumab at 200 mg on day 1, GEMOX (gemcitabine at 1,000 mg/m² on days 1 and 8 and oxaliplatin at 85 mg/m² on day 1) in 21-day cycles, and lenvatinib at 8 mg once daily. Tumor resectability was determined by a multidisciplinary team after every three cycles of treatment; patients ineligible for R0 resection or who did not require surgery after six cycles received maintenance therapy with tislelizumab plus lenvatinib at the same doses for up to 1 year. The primary outcome measure was R0 resection rate among all patients.
Key Findings
Median duration of GOLP treatment was three cycles (interquartile range [IQR] = three to six cycles).
Of 41 patients, 28 (68%) underwent surgery. At a median follow-up of 19.5 months (IQR = 14.6–25.0 months) by data cutoff (in January 2025), R0 resection had been achieved in 26 patients (63%, 95% confidence interval [CI] = 47%–78%). Two additional patients had R1 resection. Of the 28 patients undergoing surgery, 19 (68%) had recurrence; median recurrence-free survival was 8.4 months (95% CI = 7.2 months to not evaluable).
Median overall survival was: 30.8 months (95% CI = 18.5 months to not evaluable) among all patients, with 1- and 2-year rates of 81% and 57%; 30.8 months (95% CI = not evaluable to not evaluable) among patients undergoing surgery, with 1- and 2-year rates of 93% and 76%; and 13.4 months (95% CI = 7.0 months to not evaluable) among patients who did not undergo surgery, with 1- and 2-year rates of 54% and 15%.
The most common treatment-related adverse events of any grade were nausea (90%), increased alkaline phosphatase (80%), anemia (73%), and increased aspartate aminotransferase (73%); grade 3 to 4 events occurred in 49% of patients, most commonly neutropenia (34%) and increased γ-glutamyltransferase (20%). Serious treatment-related adverse events occurred in 10% of patients, most commonly neutropenia (7%). No treatment-related deaths were observed.
The investigators concluded: “With promising efficacy and manageable safety, GOLP represents a potentially feasible and high-efficiency conversion regimen for unresectable locally advanced biliary tract cancer.”
Jia Fan, MD, of the Department of Hepatobiliary Surgery and Liver Transplantation, Zhongshan Hospital, Fudan University, Shanghai, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by the Program of Shanghai Academic Research Leader, National Science and Technology Major Project of China, National Natural Science Foundation of China, and others. For full disclosures of all study authors, visit thelancet.com.
