Abstract 153P
Background
Less than 20% of patients(pts) with gallbladder carcinoma (GBCs) are eligible for surgery at the time of diagnosis. Nowadays, systemic therapy holds great promise for downstaging or even converting unresectable tumors to resectable tumors. Previous studies have shown that the conversion rate of unresectable GBCs is less than 17% only with chemotherpy. This study intends to provide a thorough analysis of the efficacy and safety of Camrelizumab in combination with gemcitabine plus oxaliplatin (GEMOX) as conversion therapy for patients (pts) diagnosed with unresectable GBCs*.
Methods
The study is an ongoing single-arm, phase II trial. A total of 37 pts diagnosed with unresectable GBCs pathologically and radiologically are expected to be enrolled. Pts enrolled will receive Camrelizumab (200mg iv. d1, q3w) combined with gemcitabine (800-1000mg/kg iv. d1, q3w) plus oxaliplatin (80-100mg/kg iv. d1, q3w) (Trial registration number: NCT05919095). Treatment is maintained for 4-8 sessions until disease progression or intolerable toxicity. The primary endpoint is radical tumor resection rate.
Results
At the data cutoff (July 2024), the median follow-up was 8.43 months(95%CI:7.23-9.63months), 8 pts had been enrolled and accepted the Camrelizumab plus GEMOX. Among them, 8 pts with hilar lymph node metastasis, 2 pts with invasion of the pancreas, 1 pts with invasion of duodenum, 4 pts with invasion portal vein or hepatic artery. After a median of 4(2-6) treatment cycles, 7 patients achieved partial response. Successful conversion rate based on radiology was 75% (6/8), of which 5 (62.5%) pts underwent R0 resection and 2 (25%) pts were waiting further surgical intervention. All patients survived without any signs of tumor recurrence. No patients had grade ≥3 treatment-related adverse events (TRAEs). For the patients who received successful conversion, the median survival time after surgery was 4.43 months (95% CI: 3.99–5.14 months).
Conclusions
Camrelizumab combined with GEMOX may be a favorable conversion therapy in unresectable GBCs patients. However, sufficient patients need to be enrolled to further evaluate the efficacy and safety of the conversion therapy.
Clinical trial identification
NCT06423170.
Editorial acknowledgement
Xiao-qiang Fang (Jiangsu Hengrui Pharmaceuticals Co., Ltd.) provided editorial assistance in the writing of the abstract.
Legal entity responsible for the study
Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Funding
Jiangsu Hengrui Pharmaceuticals Co, Ltd.
Disclosure
All authors have declared no conflicts of interest.