Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
Efficacy and Safety of Pembrolizumab Plus Paclitaxel, Cisplatin Followed by Surgery in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (KEYSTONE-001)
Verified date | April 2022 |
Source | Tianjin Medical University Cancer Institute and Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced esophageal squamous cell carcinoma.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | February 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Histologically confirmed esophageal squamous cell carcinoma; 2. Potentially resectable cT3N1M0,cT1-3N2M0(stage III)(AJCC 8 TNM classification); 3. Have a performance status of 0 or 1 on the ECOG Performance Scale; 4. Age 18-70 years old, both men and women; 5. Be willing and able to provide written informed consent/assent for the trial; 6. Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation; 7. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; 8. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor. Exclusion Criteria: 1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer; 2. Ineligibility or contraindication for esophagectomy; 3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); 5. Has severe hypersensitivity and adverse events (=Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors. |
Country | Name | City | State |
---|---|---|---|
China | Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Cancer Institute and Hospital |
China,
Kassab J, Saba L, Kassab R, Kourie HR. Tsunami of immunotherapies in the management of esophageal cancer. Immunotherapy. 2022 Aug;14(11):879-884. doi: 10.2217/imt-2022-0035. Epub 2022 Jun 15. — View Citation
Lv H, Tian Y, Li J, Huang C, Sun B, Gai C, Li Z, Tian Z. Neoadjuvant Sintilimab Plus Chemotherapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma. Front Oncol. 2022 Apr 29;12:864533. doi: 10.3389/fonc.2022.864533. eCollection 2022. — View Citation
Shang X, Zhang W, Zhao G, Liang F, Zhang C, Yue J, Duan X, Ma Z, Chen C, Pang Q, Zhang W, Liu L, Ren X, Meng B, Zhang P, Ma Y, Zhang L, Li H, Kang X, Li Y, Jiang H. Pembrolizumab Combined With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy Followed by Surgery for Locally Advanced Oesophageal Squamous Cell Carcinoma: Protocol for a Multicentre, Prospective, Randomized-Controlled, Phase III Clinical Study (Keystone-002). Front Oncol. 2022 Mar 31;12:831345. doi: 10.3389/fonc.2022.831345. eCollection 2022. — View Citation
Shang X, Zhao G, Liang F, Zhang C, Zhang W, Liu L, Li R, Duan X, Ma Z, Yue J, Chen C, Meng B, Ren X, Jiang H. Safety and effectiveness of pembrolizumab combined with paclitaxel and cisplatin as neoadjuvant therapy followed by surgery for locally advanced resectable (stage III) esophageal squamous cell carcinoma: a study protocol for a prospective, single-arm, single-center, open-label, phase-II trial (Keystone-001). Ann Transl Med. 2022 Feb;10(4):229. doi: 10.21037/atm-22-513. — View Citation
Teixeira Farinha H, Digklia A, Schizas D, Demartines N, Schafer M, Mantziari S. Immunotherapy for Esophageal Cancer: State-of-the Art in 2021. Cancers (Basel). 2022 Jan 22;14(3):554. doi: 10.3390/cancers14030554. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major pathologic response | Viable tumor comprised = 10% of resected tumor specimens | 3 months | |
Secondary | Objective response rate (ORR) | Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions | 3 months | |
Secondary | Disease-free survival (DFS) | DFS is defined as the time interval between the date of enrollment and the date of the first documented evidence of relapse after radical resection at any site or death related to cancer (including toxicity), whichever occurred first. | 24 months | |
Secondary | Overall survival (OS) | Time from the enrollment to death of any cause | 24 months | |
Secondary | Lymph node derating rate | Lymph node derating rate | At time of surgery | |
Secondary | R0 resection rate | R0 resection rate | At time of surgery |
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