NCT06684600

Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

A Single-arm, Phase II Clinical Trial of Dalpiciclib Combined with Pyrotinib As Second-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of dalpiciclib combined with pyrotinib as second-line therapy in patients with advanced esophageal squamous cell carcinoma.

Detailed description

The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. At present, the first-line treatment of advanced esophageal cancer is mainly based on the combination of paclitaxel, cisplatin and fluorouracil. After the failure of first-line treatment, there is no standard second-line treatment. The investigators designed a single-arm, phase II clinical trial of dalpiciclib combined with pyrotinib as second-line therapy in patients with advanced esophageal squamous cell carcinoma.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Dalpiciclib + Pyrotinib	Dalpiciclib Isethionate tablets, 125mg, oral administration on days 1 to 21, followed by a 7-day drug holiday, every 4 weeks; Pyrotinib Maleate tablets, 320mg, oral administration once daily on days 1 to 28, every 4 weeks; Treatment will continue until disease progression, intolerable toxicity, initiation of new antitumor therapy, withdrawal of informed consent, or the investigator determines that the subject should discontinue study treatment.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-10-30
• Completion: 2027-10-30
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: China