To hear about similar clinical trials, please enter your email below
Trial Title:
Patient-reported Outcomes in Preoperative Immunochemotherapy/Radiotherapy-treated Esophageal Cancer Patients
NCT ID:
NCT05596890
Condition:
Esophageal Squamous Cell Carcinoma
Patient-reported Outcomes
Immunotherapy
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Carboplatin
Tislelizumab
Conditions: Keywords:
Pathological complete response
Efficacy
Safety
Dysphagia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel-albumin
Description:
260mg/m2, ivdrip, d1
Arm group label:
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
60mg/m2, ivdrip, d1
Arm group label:
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC=4-6, ivdrip, d1
Arm group label:
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200mg, ivdrip, d1
Arm group label:
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Intervention type:
Radiation
Intervention name:
VMAT or IMRT
Description:
15Gy/5F (d43-d50, d57-d64), 5 times a week
Arm group label:
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Intervention type:
Procedure
Intervention name:
Esophagectomy
Description:
Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy
Arm group label:
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Guibin Qiao, MD
Phone:
13602749153
Email:
guibinqiao@126.com
Contact backup:
Last name:
Songxi Xie
Investigator:
Last name:
Guibin Qiao, MD
Email:
Principal Investigator
Investigator:
Last name:
Songxi Xie, MD
Email:
Principal Investigator
Start date:
November 30, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05596890
