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

Esophageal Squamous Cell Carcinoma Clinical Trial

— PICCRT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596890
• Other study ID #: RICE-PICCRT
• Status: Recruiting
• Phase: Phase 2
• Start date: November 30, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2022
• Source: Guangdong Provincial People's Hospital
• Contact: Guibin Qiao, MD
• Phone: 13602749153
• Email: guibinqiao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Immunotherapy
• Patient-reported Outcomes

Intervention

Drug:
• Paclitaxel-albumin
260mg/m2, ivdrip, d1
• Cisplatin
60mg/m2, ivdrip, d1
• Carboplatin
AUC=4-6, ivdrip, d1
• Tislelizumab
200mg, ivdrip, d1

Radiation:
• VMAT or IMRT
15Gy/5F (d43-d50, d57-d64), 5 times a week

Procedure:
• Esophagectomy
Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic complete response rate	The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery	Three to five working days after surgery
Secondary	Objective Response Rate (ORR)	iRECIST criteria defined complete response and partial response	Up to 24 weeks
Secondary	Safety as measured by number of participants with Grade 3 and 4 adverse events	Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0	Up to 12 weeks
Secondary	R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate	The R0 resection rate of esophagectomy	Three to five working days after surgery
Secondary	Major pathological response	less than 10% residual viable tumor follow neoadjuvant therapy	Three to five working days after surgery
Secondary	Overall survival	Overall survival rate	From the date of diagnosis to the date of death, assessed up to 100 months
Secondary	Event-free survival	EFS	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
Secondary	Dysphagia relief score	DRS	score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months