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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma Patient-reported Outcomes Immunotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant immunochemotherapy +/- short-term radiotherapy

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

Group Type EXPERIMENTAL

Paclitaxel-albumin

Intervention Type DRUG

260mg/m2, ivdrip, d1

Cisplatin

Intervention Type DRUG

60mg/m2, ivdrip, d1

Carboplatin

Intervention Type DRUG

AUC=4-6, ivdrip, d1

Tislelizumab

Intervention Type DRUG

200mg, ivdrip, d1

VMAT or IMRT

Intervention Type RADIATION

15Gy/5F (d43-d50, d57-d64), 5 times a week

Esophagectomy

Intervention Type PROCEDURE

Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy

Interventions

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Paclitaxel-albumin

260mg/m2, ivdrip, d1

Intervention Type DRUG

Cisplatin

60mg/m2, ivdrip, d1

Intervention Type DRUG

Carboplatin

AUC=4-6, ivdrip, d1

Intervention Type DRUG

Tislelizumab

200mg, ivdrip, d1

Intervention Type DRUG

VMAT or IMRT

15Gy/5F (d43-d50, d57-d64), 5 times a week

Intervention Type RADIATION

Esophagectomy

Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No