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

NCT05596890 | Unknown Phase 2

• 1 other identifier: RICE-PICCRT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma; Patient-reported Outcomes; Immunotherapy

Keywords

Pathological complete response; Efficacy; Safety; Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Objective Response Rate (ORR)

  Up to 24 weeks

• Safety as measured by number of participants with Grade 3 and 4 adverse events

  Up to 12 weeks

• 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

• Major pathological response

  Three to five working days after surgery

• Overall survival

  From the date of diagnosis to the date of death, assessed up to 100 months

Study Arms (1)

Neoadjuvant immunochemotherapy +/- short-term radiotherapy

EXPERIMENTAL

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

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

Interventions

Paclitaxel-albumin DRUG

260mg/m2, ivdrip, d1

Neoadjuvant immunochemotherapy +/- short-term radiotherapy

Cisplatin DRUG

60mg/m2, ivdrip, d1

Neoadjuvant immunochemotherapy +/- short-term radiotherapy

Carboplatin DRUG

AUC=4-6, ivdrip, d1

Neoadjuvant immunochemotherapy +/- short-term radiotherapy

Tislelizumab DRUG

200mg, ivdrip, d1

Neoadjuvant immunochemotherapy +/- short-term radiotherapy

VMAT or IMRT RADIATION

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

Neoadjuvant immunochemotherapy +/- short-term radiotherapy

Esophagectomy PROCEDURE

Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy

Neoadjuvant immunochemotherapy +/- short-term radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (1)

• Huang S, Yu H, Li Z, Tang Y, Luo L, Wu J, Li X, Shi Q, Xie S, Qiao G. Electronic patient-reported outcome-based surveillance system to evaluate safety and efficacy of preoperative immunochemotherapy with or without short-term chemoradiation in patients with esophageal squamous cell carcinoma (ePRO-PICCRT): protocol for a prospective, single-arm, phase II study. J Thorac Dis. 2024 Jul 30;16(7):4719-4726. doi: 10.21037/jtd-24-274. Epub 2024 Jul 8.

  PMID: 39144362 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Deglutition Disorders

Interventions

Cisplatin; Carboplatin; tislelizumab; Radiotherapy, Intensity-Modulated; Esophagectomy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Guibin Qiao, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guibin Qiao, MD

CONTACT

13602749153; guibinqiao@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: November 30, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

CN (1)