NCT05927844

XH-30002 Capsule Combined With Afatinib Tablets for the Treatment of Squamous Cell Carcinoma

An Open, Single-arm, Multicenter Phase Ib Clinical Study of XH-30002 Capsule Combined With Afatinib Tablets for the Treatment of Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an exploratory clinical trial and does not involve statistical assumptions or sample size estimation. the mainly purpose for the study is to evaluate the safety of XH-30002 capsule combined with afatinib tablets in the treatment of locally advanced or metastatic esophageal squamous cell carcinoma.

Detailed description

This is an open, single-arm, multicenter, investigator-initiated Phase Ib clinical study to evaluate the efficacy and safety of XH-30002 capsule in combination with afatinib maleate tablets in patients with locally advanced or metastatic esophageal squamous cell carcinoma. The primary endpoint of the study was the safety of XH-30002 capsule combined with afatinib maleate tablets.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	XH-30002 capsule	receive the study drug until the investigator assessed no longer benefit, toxic intolerance, withdrawal of consent, loss of follow-up, or death, whichever occurred first
DRUG	Afatiinb tablet	receive the study drug until the investigator assessed no longer benefit, toxic intolerance, withdrawal of consent, loss of follow-up, or death, whichever occurred first

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-07-03
• Last updated: 2023-07-03