Actively Recruiting
Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Led by Peking University · Updated on 2024-11-12
35
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender.
- Confirmed diagnosis of esophageal squamous cell carcinoma with local recurrence or distant metastasis.
- Disease progression or intolerance after first-line systemic chemotherapy.
- At least one measurable or evaluable lesion by RECIST v1.1 that has not received local treatment such as radiotherapy.
- Able to provide tissue samples for biomarker analysis.
- ECOG performance status of 0 or 1.
- Able to swallow tablets normally.
- Life expectancy of at least 12 weeks.
- Normal main organ function meeting specified blood count, liver, kidney, coagulation, and biochemical criteria.
- For women of childbearing potential, negative pregnancy test within 72 hours before first drug dose and agreement to use effective contraception during and after the trial.
- For men with partners of childbearing potential, surgical sterilization or agreement to use effective contraception during and after the trial.
- Voluntary informed consent and willingness to comply with study follow-up.
You will not qualify if you...
- Presence of uncontrollable fluid buildup like large pleural effusions or ascites.
- Chronic diarrhea or intestinal obstruction affecting medication intake.
- Long-term corticosteroid therapy over 30 days.
- Recent radiotherapy, chemotherapy, hormonal therapy, surgery, or targeted therapy within 4 weeks before enrollment.
- Unresolved side effects from previous treatments worse than grade 2 (except certain mild conditions).
- Participation in another new drug trial within 4 weeks (except observational or follow-up studies).
- Persistent low potassium or magnesium levels.
- Symptomatic or untreated brain metastases.
- History of other cancers within 5 years except certain skin and cervical cancers.
- Concurrent anti-cancer treatments.
- Known allergy to study drugs.
- Conditions predisposing to gastrointestinal bleeding or recent active bleeding.
- Active infections including tuberculosis.
- Immunodeficiency or history of organ transplant.
- Severe heart conditions within last 6 months.
- Pregnant or breastfeeding women.
- Serious other illnesses that may affect safety or study completion.
- Habitual heavy alcohol use or smoking 5 or more cigarettes daily.
- History of significant neurological or psychiatric disorders including epilepsy or dementia.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of GI Oncology, Peking University Cancer Hospital,
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
Z
Zhihao Lu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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