Patient-reported Outcomes in Preoperative Immunochemotherapy/Radiotherapy-treated Esophageal Cancer Patients

Phase 2

Recruiting

• Conditions: Patient-reported Outcomes; Immunotherapy; Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Paclitaxel-albumin; Drug: Cisplatin; Drug: Carboplatin; Drug: Tislelizumab; Radiation: VMAT or IMRT; Procedure: Esophagectomy

• Registration Number: NCT05596890
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-28
• Study Start: 2022-11-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant immunochemotherapy +/- short-term radiotherapy	Tislelizumab	Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
Neoadjuvant immunochemotherapy +/- short-term radiotherapy	Carboplatin	Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
Neoadjuvant immunochemotherapy +/- short-term radiotherapy	Esophagectomy	Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
Neoadjuvant immunochemotherapy +/- short-term radiotherapy	Paclitaxel-albumin	Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
Neoadjuvant immunochemotherapy +/- short-term radiotherapy	VMAT or IMRT	Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
Neoadjuvant immunochemotherapy +/- short-term radiotherapy	Cisplatin	Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 24 weeks	iRECIST criteria defined complete response and partial response
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
Overall survival	From the date of diagnosis to the date of death, assessed up to 100 months	Overall survival rate
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
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
Dysphagia relief score	score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months	DRS

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China