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

Peking University1 site in 1 country35 target enrollmentNovember 1, 2024

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsDalpiciclib + Pyrotinib

DrugsDalpiciclib + Pyrotinib

Overview

Phase: Phase 2
Intervention: Dalpiciclib + Pyrotinib
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Peking University
Enrollment: 35
Locations: 1
Primary Endpoint: Objective Response Rate (ORR)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2024

End Date

October 30, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18\~75 years, both men and women.；
•Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (ESCC), and local recurrence or distant metastasis；
•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.
•At least one measurable/evaluable lesion by RECIST v1.
•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 standard, can also be used as a target lesion).
•Tissue samples shall be provided for biomarker analysis, preferably newly acquired tissues, and patients who are unable to provide newly acquired tissues may provide 5-8 pieces of 5um thick paraffin sections that are archived and preserved.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or
•Capable of swallowing tablets normally.
•Life expectancy of ≥ 12 weeks.
•The main organs function normally, that is, the following criteria are met:

Exclusion Criteria

•Presence of clinically significant symptoms and uncontrollable third-space fluid accumulations, such as large pleural effusions or ascites, that cannot be managed through drainage or other methods.
•Chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction, among other factors that may affect medication intake and absorption.
•Prolonged corticosteroid therapy exceeding 30 days or requiring long-term corticosteroid use.
•Prior radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular-targeted therapy within 4 weeks of enrollment (eligible for enrollment if the last dose of anti-neoplastic medication was discontinued for ≥5 half-lives before the initial treatment); prior chemotherapy with nitrosoureas or mitomycin within 6 weeks of enrollment.
•Unresolved adverse events related to prior treatments to less than grade 2 (excluding alopecia, asthenia, and adverse events deemed by the investigator not to affect eligibility).
•Participation in another clinical trial of a new drug within 4 weeks, unless the trial is observational (non-interventional) or in a follow-up phase.
•Persistent uncorrectable hypokalemia and hypomagnesemia at the time of enrollment.
•Symptomatic or untreated brain metastases.
•History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
•Concurrent administration of other anti-neoplastic treatments.