Camrelizumab plus apatinib as second-line treatment for advanced oesophageal squamous cell carcinoma (CAP 02): a single-arm, open-label, phase 2 trial
Mené sur 52 patients atteints d'un carcinome épidermoïde de l'oesophage de stade avancé (âge : 18-75 ans ; durée médiane de suivi : 7,5 mois), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité du camrélizumab combiné à l'apatinib en traitement de deuxième ligne
Background : Camrelizumab, an anti-PD-1 antibody, has shown moderate efficacy in oesophageal squamouscell carcinoma. Apatinib, a selective inhibitor of VEGFR2, has a synergistic effectwith immunotherapy. We aimed to assess the combination of camrelizumab and apatinibas second-line treatment for advanced oesophageal squamous cell carcinoma.
Methods : This single-arm, open-label, phase 2 study was conducted at eight centres in China.Eligible patients were aged 18–75 years, with an Eastern Cooperative Oncology Groupperformance status of 0 or 1, who had unresectable locally advanced, locally recurrent,or metastatic oesophageal squamous cell carcinoma, and had progressed after or were intolerant to first-line chemotherapy. Patients received intravenous camrelizumab200 mg once every 2 weeks plus oral apatinib 250 mg once daily for a 28-day cycleuntil disease progression, unacceptable adverse events, or withdrawal of consent.The primary endpoint was investigator-assessed confirmed objective response rate.Efficacy was analysed in patients who had received at least one dose of study drug,and safety was analysed in patients who received the study drug and had at least onepost-baseline safety assessment. The study of this cohort is complete and this trialis registered with ClinicalTrials.gov, number NCT03736863.
Findings : Between Dec 5, 2019, and Feb 10, 2021, 52 patients were enrolled and included in analyses.At data cutoff (June 20, 2021), median follow-up was 7·5 months (IQR 4·0–11·2). 18(34·6%, [95% CI 22·0–49·1]) of 52 patients had a confirmed objective response. 23(44%) of 52 patients had grade 3 or worse treatment-related adverse events. The mostcommon grade 3 or worse treatment-related adverse events were increased aspartateaminotransferase (10 [19%]), increased gamma-glutamyltransferase (10 [19%]), and increasedalanine aminotransferase (five [10%]). No treatment-related deaths occurred.
Interpretation : Camrelizumab combined with apatinib showed promising activity and manageable toxicity,and might be a potential second-line treatment option for patients with advanced oesophagealsquamous cell carcinoma. Another cohort of this study, enrolling patients previouslytreated with first-line immunotherapy, is ongoing.
The Lancet Gastroenterology & Hepatology , résumé, 2021