search
Back to results

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

Primary Purpose

Esophageal Squamous Cell Carcinoma, Patient-reported Outcomes, Immunotherapy

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel-albumin
Cisplatin
Carboplatin
Tislelizumab
VMAT or IMRT
Esophagectomy
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Pathological complete response, Efficacy, Safety, Dysphagia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant immunochemotherapy +/- short-term radiotherapy

Arm Description

Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy

Outcomes

Primary Outcome Measures

Pathologic complete response rate
The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

Secondary Outcome Measures

Objective Response Rate (ORR)
iRECIST criteria defined complete response and partial response
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
R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate
The R0 resection rate of esophagectomy
Major pathological response
less than 10% residual viable tumor follow neoadjuvant therapy
Overall survival
Overall survival rate
Event-free survival
EFS
Dysphagia relief score
DRS

Full Information

First Posted
October 24, 2022
Last Updated
November 24, 2022
Sponsor
Guangdong Provincial People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05596890
Brief Title
Patient-reported Outcomes in Preoperative Immunochemotherapy/Radiotherapy-treated Esophageal Cancer Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Patient-reported Outcomes, Immunotherapy
Keywords
Pathological complete response, Efficacy, Safety, Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Arm Type
Experimental
Arm Description
Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
Intervention Type
Drug
Intervention Name(s)
Paclitaxel-albumin
Intervention Description
260mg/m2, ivdrip, d1
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
60mg/m2, ivdrip, d1
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
AUC=4-6, ivdrip, d1
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
200mg, ivdrip, d1
Intervention Type
Radiation
Intervention Name(s)
VMAT or IMRT
Intervention Description
15Gy/5F (d43-d50, d57-d64), 5 times a week
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy
Intervention Description
Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy
Primary Outcome Measure Information:
Title
Pathologic complete response rate
Description
The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
Time Frame
Three to five working days after surgery
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
iRECIST criteria defined complete response and partial response
Time Frame
Up to 24 weeks
Title
Safety as measured by number of participants with Grade 3 and 4 adverse events
Description
Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0
Time Frame
Up to 12 weeks
Title
R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate
Description
The R0 resection rate of esophagectomy
Time Frame
Three to five working days after surgery
Title
Major pathological response
Description
less than 10% residual viable tumor follow neoadjuvant therapy
Time Frame
Three to five working days after surgery
Title
Overall survival
Description
Overall survival rate
Time Frame
From the date of diagnosis to the date of death, assessed up to 100 months
Title
Event-free survival
Description
EFS
Time Frame
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
Title
Dysphagia relief score
Description
DRS
Time Frame
score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guibin Qiao, MD
Phone
13602749153
Email
guibinqiao@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guibin Qiao, MD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guibin Qiao, MD
Phone
13602749153
Email
guibinqiao@126.com
First Name & Middle Initial & Last Name & Degree
Songxi Xie
First Name & Middle Initial & Last Name & Degree
Guibin Qiao, MD
First Name & Middle Initial & Last Name & Degree
Songxi Xie, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs