NCT05990231

Cadonilimab/Anlotinib in Locally Advanced or Relapsed/Metastatic ESCC Patients After Failure of PD-1 Combined With Platinum-containing Chemotherapy

Cadonilimab Combined With Anlotinib in Locally Advanced or Relapsed/Metastatic Esophageal Squamous Cell Carcinoma Patients After Failure of PD-1 Inhibitor Combined With Platinum-containing Chemotherapy: A Single-center, Single-arm Exploratory Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Advanced esophageal squamous cell carcinoma patients who have failed first-line PD-1 inhibitor combined with chemotherapy lack a standard treatment option. Second-line treatments have limited efficacy, indicating a significant unmet clinical need. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) has anti-tumor angiogenesis and tumor growth inhibition effects. Cadonilimab is a human immunoglobulin (Ig) G1 monoclonal antibody (mAb), which is a bispecific antibody that blocks both PD-1 and CTLA-4. Both of them have shown certain efficacy and good safety in more than second-line therapy for patients with advanced esophageal squamous cell carcinoma as monotherapy. This study aims to evaluate the efficacy and safety of cadonilimab combined with anlotinib in patients with locally advanced or recurrent/metastatic esophageal squamous cell carcinoma who have progressed on PD-1 inhibitor combined with platinum-containing chemotherapy.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab combined Anlotinib	Cadonilimab: intravenous administration at a dose of 10mg/kg on day 1 of each cycle, every 3 weeks (Q3W) Anlotinib: 12mg, orally once a day (orally before breakfast, the daily medication time should be as the same as possible), continuous taking for 2 weeks, stopping for 1 week, 3 weeks (21 days) as a treatment cycle

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-08-14
• Last updated: 2023-09-11

Locations

1 site across 1 country: China