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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Enrolling; Phase 2

Conditions: Immunotherapy; Esophageal Squamous Cell Carcinoma; Patient-reported Outcomes

Treatments: Drug: Tislelizumab; Radiation: VMAT or IMRT; Drug: Cisplatin; Drug: Paclitaxel-albumin; Drug: Carboplatin; Procedure: Esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05596890

RICE-PICCRT

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Neoadjuvant immunochemotherapy +/- short-term radiotherapy

Experimental group

Description:

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

Treatment:

Procedure: Esophagectomy

Radiation: VMAT or IMRT

Drug: Tislelizumab

Drug: Carboplatin

Drug: Cisplatin

Drug: Paclitaxel-albumin