Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

The Safety and Feasibility of Neoadjuvant Adebrelimab With Dalpiciclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225921
• Other study ID #: 2024-5
• Status: Recruiting
• Phase: Phase 1
• Start date: December 29, 2023
• Est. completion date: January 15, 2025

Study information

• Verified date: March 2024
• Source: West China Hospital
• Contact: Jin Zhou, MD.,PhD.
• Phone: +8613880626596
• Email: zhoujin096[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death ligand 1(PD-L1) immunotherapy, Adebrelimab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies.

• 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:

1. The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) and cannot be resected.

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (16)

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of combination adebrelimab and dalpiciclib as assessed by number of participants who experience adverse events	Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).	up to 15 weeks
Primary	Feasibility of combination adebrelimab and dalpiciclib as assessed by number of participants who experience adverse events	Patients proceed to surgery without experiencing prolonged treatment-related delays. An extended treatment-related delay will be considered if it exceeds 37 days from the initially scheduled surgery date. In terms of feasibility, if there is any treatment toxicity of any grade that could adversely impact prognosis, as judged by the investigators, the planned operative date should be re-evaluated.	up to 15 weeks
Secondary	Maximum Tolerated Dose (MTD) of dalpiciclib as determined by number of participants with dose limiting toxicities (DLT)	Maximum tolerated dose will be determined by the maximum dose at which the least number of participants experience dose-limiting toxicity. The dose limiting toxicity is defined using the Common Terminology Criteria for Adverse Events (CTCAE).	up to 15 weeks
Secondary	Major Pathologic Response	Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells.	up to 15 weeks
Secondary	Objective response rate (ORR)	Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of Adebrelimab and Dalpiciclib	up to 15 weeks
Secondary	Progression free survival(PFS)	Proportion of participants who achieve progression free survival post treatment	Up to 2 years
Secondary	Overall survival (OS)	Proportion of participants who achieve survival post treatment	Up to 2 years