Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas
NCT ID: NCT06225921
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
6 participants
INTERVENTIONAL
2023-12-29
2025-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Adebrelimab+Dalpiciclib(100mg)
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.
Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.
Adebrelimab
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.
Dalpiciclib 100mg
Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
Adebrelimab+Dalpiciclib(150mg)
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.
Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.
Adebrelimab
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.
Dalpiciclib 150mg
Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
Interventions
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Adebrelimab
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.
Dalpiciclib 100mg
Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
Dalpiciclib 150mg
Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
Eligibility Criteria
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Inclusion Criteria
* The primary tumor should be located in the thorax.
* The patients should be evaluated to be able to have surgical resection before the surgery according to the examinations .
2. The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.
3. The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent.
Exclusion Criteria
2. Currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy.
3. History of other malignancies.
4. Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
5. Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
6. Presence of serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart diseases, etc.
7. The patients with severe systematic intercurrent diseases, including active infection or poorly controlled diabetes, coagulation disorders, hemorrhagic tendency, or those undergoing thrombolysis or anticoagulant therapy, are excluded from the study.
8. Female participants who test positive for a serum pregnancy test, are in the lactation period, or are at a childbearing stage and unwilling to use contraception measures during the research are excluded.
9. Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
10. Any other factors that are not suitable for inclusion in this study judged by investigators.
18 Years
75 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Xingchen Peng
professor
Principal Investigators
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Jin Zhou, MD.,PhD.
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2024-5
Identifier Type: -
Identifier Source: org_study_id
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