Trials / Unknown
UnknownNCT05596890
Patient-reported Outcomes in Preoperative Immunochemotherapy/Radiotherapy-treated Esophageal Cancer Patients
Patient-reported Outcome-based Surveillance System Evaluating Safety and Efficacy of Preoperative Immunochemotherapy +/- Chemoradiation in Patients With Esophageal Squamous Cell Carcinoma - A Prospective, Explorative, Phase II Study
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Guangdong Provincial People's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Currently, no effective biomarkers were identified to stratify responders and non-responders. Early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. In this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (PROs) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in PROs-insensitive patients after one cycle of neoadjuvant immunochemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paclitaxel-albumin | 260mg/m2, ivdrip, d1 |
| DRUG | Cisplatin | 60mg/m2, ivdrip, d1 |
| DRUG | Carboplatin | AUC=4-6, ivdrip, d1 |
| DRUG | Tislelizumab | 200mg, ivdrip, d1 |
| RADIATION | VMAT or IMRT | 15Gy/5F (d43-d50, d57-d64), 5 times a week |
| PROCEDURE | Esophagectomy | Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy |
Timeline
- Start date
- 2022-11-30
- Primary completion
- 2025-09-30
- Completion
- 2025-09-30
- First posted
- 2022-10-27
- Last updated
- 2022-11-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05596890. Inclusion in this directory is not an endorsement.