drugset / Trial / NCT05173246
JS001 Combined With TP as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma
Phase 2
Recruiting
43 enrolled
Sun Yat-sen University
CSPC Ouyi Pharmaceutical Co., Ltd. · collabShanghai Junshi Bioscience Co., Ltd. · collabThe First Affiliated Hospital of Zhengzhou University · collab
NaSingle-groupOpen-labelTreatment
Summary
Small cell esophageal carcinoma (SCCE) is a kind of malignant tumor with poor prognosis. Our study found that the mutation spectrum and somatic CNV spectrum of SCCE were similar to those of esophageal squamous cell carcinoma (ESCC). Paclitaxel combined with cisplatin or carboplatin is the first-line treatment for ESCC. JS001 is a Chinese anti-PD-1 monoclonal antibody, which has been approved for the treatment of melanoma. This is a prospective, single arm, multicenter, phase II clinical trial of JS001 combined with nab-paclitaxel and cisplatin or carboplatin in the first-line treatment of unresectable or advanced SCCE. Aim to evaluate the safety and efficacy of this regimen in patients with unresectable or advanced SCCE.
Timeline
- Start
- 2020-11-17
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
Publications
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- Background Huang J, Mo H, Zhang W, Chen X, Qu D, Wang X, Wu D, Wang X, Lan B, Yang B, Wang P, Zhang B, Yang Q, Jiao Y, Xu B. Promising efficacy of SHR-1210, a novel anti-programmed cell death 1 antibody, in patients with advanced gastric and gastroesophageal junction cancer in China. Cancer. 2019 Mar 1;125(5):742-749. doi: 10.1002/cncr.31855. Epub 2018 Dec 3.
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- Background Wang F, Liu DB, Zhao Q, Chen G, Liu XM, Wang YN, Su H, Qin YR, He YF, Zou QF, Liu YH, Lin YE, Liu ZX, Bei JX, Xu RH. The genomic landscape of small cell carcinoma of the esophagus. Cell Res. 2018 Jul;28(7):771-774. doi: 10.1038/s41422-018-0039-1. Epub 2018 May 4. No abstract available.
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- Background Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Corvera C, Das P, Denlinger CS, Enzinger PC, Fanta P, Farjah F, Gerdes H, Gibson M, Glasgow RE, Hayman JA, Hochwald S, Hofstetter WL, Ilson DH, Jaroszewski D, Johung KL, Keswani RN, Kleinberg LR, Leong S, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Paluri RK, Park H, Perry KA, Pimiento J, Poultsides GA, Roses R, Strong VE, Wiesner G, Willett CG, Wright CD, McMillian NR, Pluchino LA. Esophageal and Esophagogastric Junction Cancers, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Jul 1;17(7):855-883. doi: 10.6004/jnccn.2019.0033.
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- Background Paz-Ares L, Vicente D, Tafreshi A, Robinson A, Soto Parra H, Mazieres J, Hermes B, Cicin I, Medgyasszay B, Rodriguez-Cid J, Okamoto I, Lee S, Ramlau R, Vladimirov V, Cheng Y, Deng X, Zhang Y, Bas T, Piperdi B, Halmos B. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. J Thorac Oncol. 2020 Oct;15(10):1657-1669. doi: 10.1016/j.jtho.2020.06.015. Epub 2020 Jun 26.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 220 mg/m2 | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |