RecruitingPhase 2NCT06684600

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


Sponsor

Peking University

Enrollment

35 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted drugs — dalpiciclib and pyrotinib — in people with advanced esophageal squamous cell cancer that has come back or spread after prior chemotherapy. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with advanced or metastatic esophageal squamous cell carcinoma - Your cancer has progressed or you could not tolerate first-line chemotherapy - You have at least one measurable tumor on a scan - You are physically functional (ECOG 0–1) - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have uncontrolled fluid buildup around the lungs or abdomen - You have chronic diarrhea, intestinal obstruction, or bowel disease - You received other anti-cancer treatment within the past 4 weeks - You have brain metastases that are untreated or causing symptoms - You have a history of another cancer in the past 5 years - You have serious heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDalpiciclib + 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.


Locations(1)

Department of GI Oncology, Peking University Cancer Hospital,

Beijing, Beijing Municipality, China

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NCT06684600


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