← Back to Clinical Trials
Recruiting Phase 2 NCT06684600

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

Trial Parameters

Condition Esophageal Squamous Cell Carcinoma
Sponsor Peking University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 35
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-11-01
Completion 2025-10-30
Interventions
Dalpiciclib + Pyrotinib

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. 18\~75 years, both men and women.; 2. Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (ESCC), and local recurrence or distant metastasis; 3. Patients undergoing first-line systemic chemotherapy progression or intolerance (progress in maintenance therapy after first-line chemotherapy can also be included). Synchronous chemoradiotherapy for postoperative recurrence or metastasis is considered as first-line treatment; For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, Count it as a first-line treatment failure. 4. At least one measurable/evaluable lesion by RECIST v1.1. And the measurable lesions should not have received local treatment such as radiotherapy (The lesion located in the previous radiotherapy area, if confirmed to progress, and meets the RECIST 1.1

Related Trials