Camrelizumab plus oxaliplatin-based chemotherapy as first-line therapy for advanced biliary tract cancer: a multicenter, phase 2 trial
Mené sur 92 patients atteints d'un cancer des voies biliaires de stade avancé, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité du camrélizumab en combinaison avec une chimiothérapie de première ligne à base d'oxaliplatine (chimiothérapie de type FOLFOX4 ou GEMOX)
Biliary tract cancer (BTC) is a highly malignant tumor with limited treatment options and poor prognosis. This study aimed to evaluate camrelizumab plus oxaliplatin-based chemotherapy as first-line therapy for advanced BTC. In this multicenter, open-label, phase 2 trial conducted in China (ClinicalTrials.gov, NCT03092895), untreated patients with advanced BTC were given camrelizumab (3 mg/kg iv gtt, every 2 weeks) plus typical FOLFOX4 (Cam-FOLFOX4 group; infusional 5-fluorouracil, leucovorin and oxaliplatin) or GEMOX (Cam-GEMOX group; infusional gemcitabine and oxaliplatin). The primary endpoint was objective response rate (ORR). 92 patients were enrolled: 29 received Cam-FOLFOX4 and 63 received Cam-GEMOX. The confirmed ORR and disease control rate were 16.3% (95% CI: 9.4–25.5) and 75.0% (95% CI: 64.9–83.4) respectively. Median duration of response was 8.7 months (95% CI: 5.1–not reached). Median progression-free survival and overall survival were 5.3 months (95% CI: 3.7–5.7) and 12.4 months (95% CI: 8.9–16.1) respectively. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 82.8% of patients receiving Cam-FOLFOX4 and in 68.3% receiving Cam-GEMOX, with no unexpected effects observed. Six (6.5%) patients discontinued treatment due to TRAE. Camrelizumab plus FOLFOX4 or GEMOX as first-line treatment was effective and tolerable for Chinese patients with advanced BTC, warranting phase 3 trials.