A Phase 2 Prospective Trial of Capecitabine Plus Oxaliplatin as First-Line Therapy for Advanced Gall Bladder Cancers

This study aimed to evaluate the efficacy and safety of Capecitabine plus Oxaliplatin (CapOx) chemotherapy in patients with locally advanced, inoperable, or metastatic adenocarcinoma of the gallbladder. The primary objective of the study was to determine the objective tumour response rates (complete and partial). The secondary objectives included assessment of toxicity, progression free survival, and overall survival.

A prospective, single-arm, phase II study was conducted at a single center between January 2021 and December 2021. Forty-three patients with histologically confirmed advanced gallbladder adenocarcinoma were enrolled. All patients received CapOx chemotherapy (Capecitabine 1000 mg/m² orally twice daily for 14 days and Oxaliplatin 130 mg/m² intravenously on day 1, every 3 weeks for six cycles). Tumor responses were assessed clinically after each cycle and radiologically after three cycles using RECIST 1.1 criteria. Treatment-related adverse events were graded per NCI CTCAE version 5. Progression-free survival (PFS) and overall survival (OS) were analyzed using SPSS version 29.

Among the 43 patients, 35 completed three or more cycles, and 19 completed six cycles. The objective response rate (ORR) was 30.2%, and the disease control rate (DCR) was 65.1%. Median OS for all patients was 7.4 months, and PFS was 5.5 months. In patients completing six cycles, median OS was 9.8 months, and PFS was 7.3 months. The most common metastatic site was the liver. Sensory neuropathy was observed in 58.1% of patients, with grade 3/4 toxicity in 16.3%. Other reported toxicities included anemia (grade 3 in four patients), biochemical abnormalities, and gastrointestinal symptoms.

CapOx chemotherapy demonstrated modest efficacy with a disease control rate of 65.1% in patients with advanced gallbladder cancer. Toxicities were generally manageable, with sensory neuropathy being the most common. Further studies are needed to validate these findings and explore additional therapeutic options.