Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study.

Abstract

e16070 Background: Our preliminary results suggested potential synergistic activity of fruquintinib combined with camrelizumab, paclitaxel liposome, and nedaplatin in first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). Here we present updated findings from our study (NCT06010212). Methods: This study included a dose-finding (3+3 design) phase to determine the recommended phase 2 dose (RP2D) of fruquintinib and a dose-expansion phase in which patients received camrelizumab (200 mg), paclitaxel liposome (135 mg/m²), and nedaplatin (70 mg/m²) on day 1 of each 3-week cycle, along with fruquintinib 5 mg daily on days 1-14 of each cycle. A maximum of six cycles was administered, followed by maintenance therapy with fruquintinib and camrelizumab. The primary endpoint was objective response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and safety. Results: AS of December 15, 2025, 34 patients (median age 66; 29 males) were enrolled. Patients with three or more organ metastases accounted for 41.2% (14/34), primarily involving lymph nodes (91.2%, 31/34), lung (47.1%, 16/34), and liver (32.4%, 11/34). Tumors were G3 in 29.4% (10/34) of patients. Radical surgery was performed in 23.5% (8/34) of patients, and adjuvant chemotherapy was administered in 11.8% (4/34) of patients. Among intention-to-treat population (34 patients), the confirmed ORR was 64.7% (22/34; 95% CI: 48.6%–80.8%) and DCR was 94.1% (32/34; 95% CI: 80.3%–99.3%). At a median follow-up of 16.1 months and 15.3 months, the median PFS was 13.7 months (95% CI: 10.3–not reached [NR]) and the median OS was NR (95% CI: 18.8–NR). The 1-year PFS rate and 1-year OS rate were 58.6% and 83.9%, respectively. Treatment-related adverse events (TRAEs) occurred in 33 patients (97.1%). The most common(≥40%) TRAEs were anemia (82.4%), hypoproteinemia (50.0%), and nausea (41.2%). Grade ≥3 TRAEs were observed in 13 patients (38.2%), most commonly (≥10%) neutropenia and leukopenia (20.6% each). Dose modifications (discontinuation or dose reduction) due to TRAEs were necessary in 15 of 34 patients (44.1%). No serious adverse events occurred. Conclusions: The combination of fruquintinib, camrelizumab, paclitaxel liposome, and nedaplatin demonstrated encouraging anti-tumor activity with a manageable toxicity profile as a first-line treatment for advanced ESCC, warranting further investigation in larger, randomized studies. Clinical trial information: NCT06010212 .