Esophageal Squamous Cell Carcinoma, Patient-reported Outcomes, Immunotherapy
Conditions
Keywords
Pathological complete response, Efficacy, Safety, Dysphagia
Brief 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.
Interventions
260mg/m2, ivdrip, d1
DRUGCisplatin
60mg/m2, ivdrip, d1
DRUGCarboplatin
AUC=4-6, ivdrip, d1
DRUGTislelizumab
200mg, ivdrip, d1
RADIATIONVMAT or IMRT
15Gy/5F (d43-d50, d57-d64), 5 times a week
PROCEDUREEsophagectomy
Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response rate | Three to five working days after surgery | The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety as measured by number of participants with Grade 3 and 4 adverse events | Up to 12 weeks | Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0 |
| R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate | Three to five working days after surgery | The R0 resection rate of esophagectomy |
| Major pathological response | Three to five working days after surgery | less than 10% residual viable tumor follow neoadjuvant therapy |
| Objective Response Rate (ORR) | Up to 24 weeks | iRECIST criteria defined complete response and partial response |
| Event-free survival | From the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months | EFS |
| Dysphagia relief score | score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months | DRS |
| Overall survival | From the date of diagnosis to the date of death, assessed up to 100 months | Overall survival rate |
Countries
China
Contacts
Primary ContactGuibin Qiao, MD
Outcome results
None listed