drugset / Trial / NCT06086457
PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer
Phase 3
Recruiting
436 enrolled
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Affiliated Hospital of North Sichuan Medical College · collabAnyang Tumor Hospital · collabBeijing Cancer Prevention & Treatment Society · collabChangzhou Cancer Hospital of Soochow University · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabFujian Cancer Hospital · collabHebei Medical University Fourth Hospital · collabHenan Cancer Hospital · collabPeking University Cancer Hospital & Institute · collabSecond Affiliated Hospital of Xi'an Jiaotong University · collabSichuan Cancer Hospital and Research Institute · collabTengzhou Central People's Hospital · collabThe First Affiliated Hospital of Xiamen University · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First Affiliated Hospital with Nanjing Medical University · collabTianjin Medical University Cancer Institute and Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The treatment efficacy for stage IVb esophageal cancer has been improved through chemotherapy combined with immunotherapy recently. On this basis, the investigators intend to conduct a prospective, multicenter phase III clinical trial to assess whether radiotherapy with concurrent chemotherapy and immunotherapy could further improve the survival of patients with metastatic esophageal cancer. Accompanied tissue samples, blood samples and urine samples will be analyzed by molecular biological detection (Including Whole Exome Sequencing and proteomics) to explore potential biomarkers for predicting outcomes, efficacy and toxicity.
Timeline
- Start
- 2024-02-04
- Primary completion
- 2026-06-28
- Completion
- 2029-08-28
Publications
- Background Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4.
- Background Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.
- Background Guttmann DM, Mitra N, Bekelman J, Metz JM, Plastaras J, Feng W, Swisher-McClure S. Improved Overall Survival with Aggressive Primary Tumor Radiotherapy for Patients with Metastatic Esophageal Cancer. J Thorac Oncol. 2017 Jul;12(7):1131-1142. doi: 10.1016/j.jtho.2017.03.026. Epub 2017 Apr 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Camrelizumab | Monoclonal antibody | 200 mg | — |
| Background | Capecitabine | Small molecule | 800 mg/m2 | — |
| Background | Cisplatin | Other / unclassified | 60 mg/m2 | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 110 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 130 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 150 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | — |