drugset / Trial / NCT06084897
Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy
Phase 2
Recruiting
120 enrolled
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Anyang Tumor Hospital · collabHebei Medical University Fourth Hospital · collabPeking University Cancer Hospital & Institute · 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 II clinical trial to assess whether radiotherapy could further improve the survival of patients with metastatic esophageal cancer responding to PD-1 Inhibitor plus chemotherapy. 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
- 2023-10-16
- Primary completion
- 2026-04-26
- Completion
- 2028-10-26
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 | — | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |
| Background | Serplulimab | Monoclonal antibody | — | — |
| Background | Sintilimab | Monoclonal antibody | — | — |
| Background | Tislelizumab | Monoclonal antibody | — | — |
| Background | Toripalimab | Monoclonal antibody | — | — |
| Background | fluorouracil | Small molecule | — | — |