Clinical trial NCT05596890: Patient-reported Outcomes in Preoperative Immunochemotherapy/Radiotherapy-treated Esophageal Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Patient-reported Outcomes
Immunotherapy
Keywords: Pathological complete response
Efficacy
Safety
Dysphagia
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pathologic complete response rate
timeFrame: Three to five working days after surgery
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 weeks
measure: Safety as measured by number of participants with Grade 3 and 4 adverse events
timeFrame: Up to 12 weeks
measure: R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate
timeFrame: Three to five working days after surgery
measure: Major pathological response
timeFrame: Three to five working days after surgery
measure: Overall survival
timeFrame: From the date of diagnosis to the date of death, assessed up to 100 months
measure: Event-free survival
timeFrame: 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
measure: Dysphagia relief score
timeFrame: score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Guibin Qiao, MD
role: PRINCIPAL_INVESTIGATOR
References: