Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Immunotherapy | — | UNRESOLVED | — |
| Patient-reported Outcomes | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Esophagectomy | Procedure | — | UNRESOLVED |
| Paclitaxel-albumin | Drug | Nab-paclitaxel | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| VMAT or IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant immunochemotherapy +/- short-term radiotherapy
- description
- Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
- interventionNames
- Drug: Paclitaxel-albumin
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Tislelizumab
- Radiation: VMAT or IMRT
- Procedure: Esophagectomy
Primary outcomes (1)
- measure
- Pathologic complete response rate
- timeFrame
- Three to five working days after surgery
- description
- The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed esophageal squamous cell carcinoma * Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4aN1-2M0, cT3-T4aN0M0) * Treatment-naive * Expected life span \> 6 months * Aged 18 - 75 years old * Adequate organ functions * PS 0-2 * Participants are fully informed about the whole study and are willing to sign the informed consent Exclusion Criteria: * Previous history of thoracic surgery or radiation * Cervical or multi-origin esophageal cancer * Known or suspected experimental drug allergy * Pregnant or lactating women * Esophagomediastianl fistula * Peripheral neuropathy * Previous cancer history other than esophageal cancer * Severe organ function deterioration that can not tolerate neoadjuvant therapy * Previous autoimmune diseases * diabetic history \> 10 years * interstitial pulmonary disease, non-infectious pulmonitis * Active type B hepatitis * Any other conditions that may affect patients' safety and compliance
References
Publications (1)
- DERIVEDHuang S, Yu H, Li Z, Tang Y, Luo L, Wu J, Li X, Shi Q, Xie S, Qiao G. Electronic patient-reported outcome-based surveillance system to evaluate safety and efficacy of preoperative immunochemotherapy with or without short-term chemoradiation in patients with esophageal squamous cell carcinoma (ePRO-PICCRT): protocol for a prospective, single-arm, phase II study. J Thorac Dis. 2024 Jul 30;16(7):4719-4726. doi: 10.21037/jtd-24-274. Epub 2024 Jul 8. PMID 39144362