NCT06599775

Study of Adebrelimab With Chemotherapy, Endoscopy and Sequential Chemoradiotherapy In Inoperable Esophageal Cancer

Prospective, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Chemotherapy, Endoscopic Resection and Sequential Chemoradiotherapy In the Treatment of Inoperable Clinical Staging T1b-2 Esophageal Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the efficacy and safety of PD-L1 (Programmed Death-L1)antibody combined with endoscopy and radiotherapy for inoperable cT1b-2 (clinical stage tumor 1b-2) esophageal squamous cell carcinoma

Detailed description

Previous studies have already confirm immunotherapy combine with chemotherapy can improve pathological complete response rates. Therefore, it is proposed to carry out a study of immuno-combination chemotherapy combined with endoscopic resection and synchronous radiotherapy and chemotherapy in patients with clinical stage cT1-2N0M0 (clinical stage tumor 1b-2 clinical stage nodes 0 stage metastasis 0) to evaluate the efficacy and safety

Conditions

• Resectable Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Adebrelimab injection	Experimental group：Adebrelimab is an innovative PD-L1 inhibitor, monotherapy can improve pathological complete response rates with tolerable safety
DRUG	Albumin-Bound Paclitaxel	Experimental group：combined with Adebrelimab（PD-L1 inhibitor）,and carboplatin followed by endoscopic resection and subsequent simultaneous radiotherapy combined with albumin-bound paclitaxel and carboplatin
DRUG	Carboplatin injection	Experimental group：combined with Adebrelimab（PD-L1 inhibitor），and albumin-bound paclitaxel followed by endoscopic resection and subsequent simultaneous radiotherapy combined with albumin-bound paclitaxel and carboplatin

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2028-10-01
• First posted: 2024-09-19
• Last updated: 2024-09-19