What type of study is this?

This is a Phase 2 study (also classified as: Observational).

September 10, 2025

Camrelizumab, Paclitaxel and Nedaplatin as Conversion Therapy for Locally Advanced/Advanced Esophageal Squamous Cell Carcinoma: A Phase Ii, Single-Arm Study

Key Points

The study reveals a 56.7% objective response rate for patients with unresectable esophageal squamous cell carcinoma, indicating good efficacy.
Among the patients treated, the surgical conversion rate was found to be 48.9%, enhancing the potential for surgical resection.
Utilizing a model that combines habitat radiomics data with clinical variables, the study effectively predicts pathological complete response rates.
Adverse events were reported in 75.9% of patients, suggesting that while the therapy is promising, monitoring for side effects is important.

Abstract

Abstract Background This study investigated the efficacy and safety of camrelizumab in combination with paclitaxel and nedaplatin as preoperative therapy for patients with unresectable esophageal squamous cell carcinoma (ESCC). We also examined the tumor microenvironment through habitat radiomics to evaluate its potential for predicting treatment response. Methods This single-arm, phase II study enrolled patients with clinically confirmed unresectable ESCC (staged T2–4, Nany, M0/M1). Participants received camrelizumab (200 mg) with paclitaxel (155 mg/m2) and nedaplatin (80 mg/m2) every three weeks. Efficacy was assessed every two cycles to evaluate operability. Endpoints included overall survival (OS) at 12 months, pathological complete response (pCR) rates, objective response rate (ORR), disease control rate (DCR), and disease-free survival (DFS). We also utilized retrospective clinical data as training set and the patient data of this study as test set to extract radiomic features from the tumor and its surrounding environment. Results Among 134 patients analyzed, the overall ORR was 56.7%. The surgical conversion rate was 48.9%. In a pathological analysis of 67 patients, the pCR rate was 20.9%, and the major pathological response (MPR) rate was 55.2%. The median OS for all patients was 30.7 months, and 12.8 months for non-surgical patients. The median OS for surgical patients has not been reached, but significantly higher than OS of non-surgical patients. The median DFS for surgical patients has not been reached. Adverse events occurred in 75.9% of patients. A model integrating intratumoral and peritumoral habitat radiomics with clinical variables effectively predicted pCR. Conclusion The combination of camrelizumab, paclitaxel, and nedaplatin demonstrates promising efficacy and manageable adverse effects as a conversion therapy, enhancing surgical resectability and survival outcomes without delaying surgery.

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